Nonhuman Biologics Definition

Nonhuman Biologics Definition: A Deep Dive into the World Beyond Human Therapeutics

Introduction:

Are you intrigued by the burgeoning field of biologics, but find yourself lost in the complexities of "nonhuman" applications? This comprehensive guide unravels the definition of nonhuman biologics, exploring their diverse applications, regulatory landscapes, and future implications. We'll delve into the scientific underpinnings, discuss key examples, and navigate the ethical considerations surrounding this rapidly evolving area of biotechnology. Prepare to unravel the mysteries of this fascinating and potentially transformative field. This post offers a detailed exploration of nonhuman biologics, ensuring you gain a complete understanding of their scope and significance.

What are Nonhuman Biologics? A Clear Definition

The term "biologics" broadly refers to therapeutic products derived from living organisms. These include vaccines, antibodies, blood components, gene therapies, and numerous other complex substances. Nonhuman biologics, therefore, are those derived from sources other than humans. This crucial distinction opens up a vast array of possibilities, utilizing the unique biological properties of various species to address a multitude of health challenges in both animals and humans. Think of it as harnessing the power of nature's biological diversity for therapeutic gain. This definition goes beyond simply using animal-derived components; it encompasses the entire spectrum of biological materials sourced from non-human organisms, engineered and employed for therapeutic purposes.

Sources of Nonhuman Biologics:

The diversity of nonhuman biologics mirrors the biodiversity of the planet. Major sources include:

Animals: This is perhaps the most commonly understood source. Antibodies derived from animals like mice (monoclonal antibodies) have revolutionized cancer treatment and other therapeutic areas. Other animal-derived products include growth factors and hormones.
Plants: Plant-based biologics offer a sustainable and often readily accessible source of therapeutic compounds. Many traditional medicines utilize plant-derived compounds with proven efficacy, and modern biotechnology is refining and optimizing these for greater potency and safety.
Microorganisms: Bacteria, fungi, and yeast are prolific producers of biologically active molecules, including antibiotics, enzymes, and various therapeutic proteins. Genetic engineering techniques have significantly enhanced the yield and efficiency of these microbial production systems.
Marine Organisms: The ocean is a vast reservoir of undiscovered bioactive compounds. Marine-derived biologics hold immense potential for drug discovery, particularly in areas like anti-cancer and anti-inflammatory therapies.

Applications of Nonhuman Biologics:

The applications of nonhuman biologics are extensive and span various fields:

Human Medicine: As mentioned, monoclonal antibodies derived from mice are widely used in cancer therapy, autoimmune diseases, and infectious diseases. Other nonhuman biologics are crucial in organ transplantation, blood clotting disorders, and numerous other therapeutic areas.
Veterinary Medicine: Nonhuman biologics are essential for treating diseases in animals, mirroring many applications in human medicine. Vaccines, antibiotics, and other therapeutics contribute significantly to animal health and welfare.
Agricultural Biotechnology: Biologics play a vital role in enhancing crop yields and pest resistance. Genetically modified organisms (GMOs) and biopesticides represent some notable examples.
Industrial Biotechnology: Enzymes derived from microorganisms are widely used in various industrial processes, including food production, textile manufacturing, and biofuel production.

Regulatory Landscape and Ethical Considerations:

The development and use of nonhuman biologics are subject to stringent regulations to ensure safety and efficacy. Regulatory bodies like the FDA (in the US) and EMA (in Europe) have established rigorous guidelines for the production, testing, and approval of these products. Ethical considerations are also paramount, particularly concerning animal welfare in the production of animal-derived biologics. The principles of the "3Rs" – Replacement, Reduction, and Refinement – guide efforts to minimize animal suffering.

The Future of Nonhuman Biologics:

The future of nonhuman biologics is bright, fueled by advancements in genetic engineering, synthetic biology, and high-throughput screening technologies. We can anticipate:

Personalized medicine: Tailored therapies leveraging the unique properties of specific nonhuman biologics to target individual patient needs.
Novel drug discovery: Exploring untapped sources of biodiversity for the identification of new therapeutic compounds.
Sustainable production: Developing environmentally friendly methods for producing nonhuman biologics.
Enhanced safety and efficacy: Refining production processes to ensure higher quality and reduce adverse effects.


Article Outline: "Nonhuman Biologics: A Comprehensive Guide"

Introduction: Defining nonhuman biologics and outlining the scope of the article.
Chapter 1: Sources of Nonhuman Biologics: Detailing animal, plant, microbial, and marine sources.
Chapter 2: Applications of Nonhuman Biologics: Exploring uses in human and veterinary medicine, agriculture, and industry.
Chapter 3: Regulatory Aspects and Ethical Considerations: Discussing safety regulations and ethical implications.
Chapter 4: Future Directions and Challenges: Exploring future trends and potential obstacles.
Conclusion: Summarizing key points and highlighting the importance of nonhuman biologics.


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FAQs:

1. What is the difference between human and nonhuman biologics? Human biologics are derived from humans; nonhuman biologics are from other organisms.
2. Are nonhuman biologics safe? Rigorous testing and regulations ensure safety, but potential risks exist as with any medication.
3. What are the ethical concerns surrounding nonhuman biologics? Primarily animal welfare in animal-derived products; ensuring responsible sourcing and minimal suffering.
4. How are nonhuman biologics regulated? Strict regulatory agencies (like FDA & EMA) oversee production, testing, and approval.
5. What are the major applications of nonhuman biologics in medicine? Cancer treatment, autoimmune diseases, organ transplantation, and infectious diseases.
6. What is the role of genetic engineering in nonhuman biologics? Enhancing production, improving efficacy, and creating novel therapeutic molecules.
7. What are some examples of plant-derived nonhuman biologics? Many traditional medicines, such as those containing compounds like Taxol (from the yew tree).
8. How are marine organisms used in nonhuman biologics? Discovery of novel bioactive compounds with potential therapeutic applications.
9. What are the future prospects for nonhuman biologics? Personalized medicine, novel drug discovery, sustainable production, and enhanced safety.


Related Articles:

1. Monoclonal Antibodies: A Deep Dive: Explores the production, applications, and limitations of monoclonal antibody therapies.
2. The Ethics of Animal Research in Biologics: Discusses the ethical considerations and best practices in animal-based research.
3. Plant-Based Biopharmaceuticals: A Sustainable Future: Examines the potential of plant-derived biologics as a sustainable therapeutic source.
4. Marine Bioprospecting and Drug Discovery: Explores the vast potential of the ocean for discovering novel therapeutic compounds.
5. The FDA Approval Process for Biologics: Details the regulatory pathway for bringing biologics to market.
6. Genetic Engineering and Biologics Production: Explores the role of genetic modification in improving the efficiency and efficacy of biologic production.
7. Biosimilars and Biobetters: A Comparative Analysis: Compares the similarities and differences between biosimilars and the original biologics.
8. Advances in Microbial Bioprocessing: Explores the latest advancements in using microorganisms for producing therapeutic biologics.
9. The Future of Personalized Medicine with Biologics: Discusses how biologics can be tailored to individual patients for better treatment outcomes.


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  nonhuman biologics definition: Safe and Effective Medicines for Children Institute of Medicine, Board on Health Sciences Policy, Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), 2012-10-13 The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
  nonhuman biologics definition: The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment Joerg Bluemel, Sven Korte, Emanuel Schenck, Gerhard Weinbauer, 2015-03-13 The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. - Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more - Includes practical examples on techniques and methods to guide your daily practice - Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes
  nonhuman biologics definition: Nonhuman Primates in Biomedical Research Christian R. Abee, Keith Mansfield, Suzette D. Tardif, Timothy Morris, 2012-05-09 The 2e of the gold standard text in the field, Nonhuman Primates in Biomedical Research provides a comprehensive, up-to-date review of the use of nonhuman primates in biomedical research. The Biology and Management volume provides basic information on the natural biology of nonhuman primates and the current state of knowledge regarding captive management. Each chapter contains an extensive list of bibliographic references, photographs, and graphic illustrations to provide the reader with a thorough review of the subject. - Now in four color throughout, making the book more visually stimulating to enhance learning and ease of use - Fully revised and updated, providing researchers with the most comprehensive review of the use of nonhuman primates in biomedical research - Addresses commonly used nonhuman primate biomedical models, providing researchers with species-specific information
  nonhuman biologics definition: Biologics, Biosimilars, and Biobetters Iqbal Ramzan, 2021-02-03 A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
  nonhuman biologics definition: Pharmaceutical Lifecycle Management Tony Ellery, Neal Hansen, 2012-04-16 A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands. Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future. While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.
  nonhuman biologics definition: Nonhuman Primates in Biomedical Research,Two Volume Set Christian R. Abee, Keith Mansfield, Suzette D. Tardif, Timothy Morris, 2012-12-31 The 2e of the gold standard text in the field, Nonhuman Primates in Biomedical Research provides a comprehensive, up-to-date review of the use of nonhuman primates in biomedical research. The publication emphasizes the biology and management, diseases, and biomedical models for nonhuman primate species most commonly used in research. Each chapter contains an extensive list of bibliographic references, photographs, and graphic illustrations to provide the reader with a thorough review of the subject. The Biology and Management volume provides basic information on the natural biology of nonhuman primates and the current state of knowledge regarding captive management. The Diseases volume provides thorough reviews of naturally occurring diseases of nonhuman primates, with a section on biomedical models reviewing contemporary nonhuman primate models of human diseases. - Now in four color throughout, making the book more visually stimulating to enhance learning and ease of use - Fully revised and updated, providing researchers with the most comprehensive review of the use of nonhuman primates in biomedical research - Addresses commonly used nonhuman primate biomedical models, providing researchers with species-specific information
  nonhuman biologics definition: Challenges in Nonhuman Primate Research in the 21st Century Gerhard F. Weinbauer, Friedhelm Vogel, 2012
  nonhuman biologics definition: Adolescent Development and the Biology of Puberty National Research Council and Institute of Medicine, Division of Behavioral and Social Sciences and Education, Commission on Behavioral and Social Sciences and Education, Forum on Adolescence, 1999-07-20 Adolescence is one of the most fascinating and complex transitions in the human life span. Its breathtaking pace of growth and change is second only to that of infancy. Over the last two decades, the research base in the field of adolescence has had its own growth spurt. New studies have provided fresh insights while theoretical assumptions have changed and matured. This summary of an important 1998 workshop reviews key findings and addresses the most pressing research challenges.
  nonhuman biologics definition: Biosimilars and Interchangeable Biologics Sarfaraz K. Niazi, 2018-10-30 What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.
  nonhuman biologics definition: Preclinical Safety Evaluation of Biopharmaceuticals Joy A. Cavagnaro, 2013-03-07 The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies. —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.
  nonhuman biologics definition: Occupational Health and Safety in the Care and Use of Nonhuman Primates National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research, Committee on Occupational Health and Safety in the Care and Use of Nonhuman Primates, 2003-06-13 The field of occupational health and safety constantly changes, especially as it pertains to biomedical research. New infectious hazards are of particular importance at nonhuman-primate facilities. For example, the discovery that B virus can be transmitted via a splash on a mucous membrane raises new concerns that must be addressed, as does the discovery of the Reston strain of Ebola virus in import quarantine facilities in the U.S. The risk of such infectious hazards is best managed through a flexible and comprehensive Occupational Health and Safety Program (OHSP) that can identify and mitigate potential hazards. Occupational Health and Safety in the Care and Use of Nonhuman Primates is intended as a reference for vivarium managers, veterinarians, researchers, safety professionals, and others who are involved in developing or implementing an OHSP that deals with nonhuman primates. The book lists the important features of an OHSP and provides the tools necessary for informed decision-making in developing an optimal program that meets all particular institutional needs.
  nonhuman biologics definition: Rational Therapeutics for Infants and Children Institute of Medicine, Division of Health Sciences Policy, Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, Jonathan R. Davis, Sarah Pitluck, Peter Bouxsein, Ronald W. Estabrook, 2000-04-07 The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.
  nonhuman biologics definition: FDA Approved Animal Drug Products , 1998
  nonhuman biologics definition: The Singularity Is Near Ray Kurzweil, 2005-09-22 NEW YORK TIMES BESTSELLER • Celebrated futurist Ray Kurzweil, hailed by Bill Gates as “the best person I know at predicting the future of artificial intelligence,” presents an “elaborate, smart, and persuasive” (The Boston Globe) view of the future course of human development. “Artfully envisions a breathtakingly better world.”—Los Angeles Times “Startling in scope and bravado.”—Janet Maslin, The New York Times “An important book.”—The Philadelphia Inquirer At the onset of the twenty-first century, humanity stands on the verge of the most transforming and thrilling period in its history. It will be an era in which the very nature of what it means to be human will be both enriched and challenged as our species breaks the shackles of its genetic legacy and achieves inconceivable heights of intelligence, material progress, and longevity. While the social and philosophical ramifications of these changes will be profound, and the threats they pose considerable, The Singularity Is Near presents a radical and optimistic view of the coming age that is both a dramatic culmination of centuries of technological ingenuity and a genuinely inspiring vision of our ultimate destiny.
  nonhuman biologics definition: FDA Regulatory Affairs Douglas J. Pisano, David S. Mantus, 2008-08-11 Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in
  nonhuman biologics definition: 1997 United States Biotechnology Regulations Handbook Edward L. Korwek, 1997
  nonhuman biologics definition: CDC Yellow Book 2018: Health Information for International Travel Centers for Disease Control and Prevention CDC, 2017-04-17 THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.
  nonhuman biologics definition: Fundamentals of Law and Regulation: An in-depth look at therapeutic products Robert P. Brady, 1997
  nonhuman biologics definition: Essentials of Glycobiology Ajit Varki, Maarten J. Chrispeels, 1999 Sugar chains (glycans) are often attached to proteins and lipids and have multiple roles in the organization and function of all organisms. Essentials of Glycobiology describes their biogenesis and function and offers a useful gateway to the understanding of glycans.
  nonhuman biologics definition: Guide for the Care and Use of Laboratory Animals National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research, Committee for the Update of the Guide for the Care and Use of Laboratory Animals, 2011-01-27 A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.
  nonhuman biologics definition: Public Health Service Policy on Humane Care and Use of Laboratory Animals National Institutes of Health (U.S.). Office for Protection from Research Risks, 1986
  nonhuman biologics definition: The ADME Encyclopedia Alan Talevi, 2022-06-14 The ADME Encyclopedia covers pharmacokinetic phenomena (Absorption, Distribution, Metabolism and Excretion processes) and their relationship with the design of pharmaceutical carriers and the success of drug therapies. It covers both basic and advanced knowledge, serving as introductory material for students of biomedical careers and also as reference, updated material for graduates and professionals working in any field related to pharmaceutical sciences (medicine, pharmaceutical technology, materials science, medicinal chemistry). Structured as alphabetically ordered entries with cross-references, the Encyclopedia not only provides basic knowledge on ADME processes, but also detailed entries on some advanced subjects such as drug transporters, last generation pharmaceutical carriers, pharmacogenomics, personalized medicine, bioequivalence studies, biowaivers, biopharmaceuticals, gene delivery, pharmacometrics, pharmacokinetic drug interactions or in silico and in vitro assessment of ADME properties
  nonhuman biologics definition: Biotechnology Law for the 1990s , 1989
  nonhuman biologics definition: Therapeutic Antibody Engineering William R Strohl, Lila M Strohl, 2012-10-16 The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. - Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships - Integration of knowledge across all areas of antibody engineering, development, and marketing - Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity
  nonhuman biologics definition: Macachiavellian Intelligence Dario Maestripieri, 2008-09-15 Judged by population size and distribution, homo sapiens are clearly the most successful primates. A close second, however, would be rhesus macaques, who have adapted to—and thrived in—such diverse environments as mountain forests, dry grasslands, and urban sprawl. Scientists have spent countless hours studying these opportunistic monkeys, but rhesus macaques have long been overshadowed in the public eye by the great apes, who, because of their greater intelligence, are naturally assumed to have more to teach us, both about other primates and about humans as well. Dario Maestripieri thinks it is high time we shelve that misperception, and with Macachiavellian Intelligence he gives rhesus macaques their rightful turn in the spotlight. The product of more than twenty years studying these fascinating creatures, Macachiavellian Intelligence caricatures a society that is as much human as monkey, with hierarchies and power struggles that would impress Machiavelli himself. High-status macaques, for instance, maintain their rank through deft uses of violence and manipulation, while altruism is almost unknown and relationships are perpetually subject to the cruel laws of the market. Throughout this eye-opening account, Maestripieri weds his thorough knowledge of macaque behavior to his abiding fascination with human society and motivations. The result is a book unlike any other, one that draws on economics as much as evolutionary biology, politics as much as primatology. Rife with unexpected connections and peppered with fascinating anecdotes, Macachiavellian Intelligence has as much to teach us about humans as it does about macaques, presenting a wry, rational, and wholly surprising view of our humanity as seen through the monkey in the mirror.
  nonhuman biologics definition: An Overview of FDA Regulated Products Eunjoo Pacifici, Susan Bain, 2018-06-13 Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
  nonhuman biologics definition: Regulatory Aspects of Gene Therapy and Cell Therapy Products Maria Cristina Galli, Mercedes Serabian, 2015-09-15 This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent must-know guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
  nonhuman biologics definition: Translational Medicine Joy A. Cavagnaro, Mary Ellen Cosenza, 2021-11-26 Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses What-Why-When-How highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
  nonhuman biologics definition: Importing Into the United States U. S. Customs and Border Protection, 2015-10-12 Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
  nonhuman biologics definition: Human Genome Editing National Academies of Sciences, Engineering, and Medicine, National Academy of Medicine, National Academy of Sciences, Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations, 2017-08-13 Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.
  nonhuman biologics definition: Biological Drug Products Wei Wang, Manmohan Singh, 2013-08-29 Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
  nonhuman biologics definition: FDA Regulatory Affairs David Mantus, Douglas J. Pisano, 2014-02-28 FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
  nonhuman biologics definition: Principles of Regenerative Medicine Anthony Atala, Robert Lanza, James A. Thomson, Robert Nerem, 2010-12-16 Virtually any disease that results from malfunctioning, damaged, or failing tissues may be potentially cured through regenerative medicine therapies, by either regenerating the damaged tissues in vivo, or by growing the tissues and organs in vitro and implanting them into the patient. Principles of Regenerative Medicine discusses the latest advances in technology and medicine for replacing tissues and organs damaged by disease and of developing therapies for previously untreatable conditions, such as diabetes, heart disease, liver disease, and renal failure. - Key for all researchers and instituions in Stem Cell Biology, Bioengineering, and Developmental Biology - The first of its kind to offer an advanced understanding of the latest technologies in regenerative medicine - New discoveries from leading researchers on restoration of diseased tissues and organs
  nonhuman biologics definition: To Err Is Human Institute of Medicine, Committee on Quality of Health Care in America, 2000-03-01 Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€with state and local implicationsâ€for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€which begs the question, How can we learn from our mistakes? Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine
  nonhuman biologics definition: Development of FDA-Regulated Medical Products Elaine Whitmore, 2012-02-15 Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates. I have been working in medical device design and design assurance for over 10 years...Elaine Whitmore really gets this right...The point is that quality regulations are not going to go away, and those responsible for healthcare product development will have to lead the charge to keep up the momentum in their organizations. I am going to have to buy several copies of this for my clients! Joseph P. Sener, P.E.
  nonhuman biologics definition: The UFAW Handbook on the Care and Management of Laboratory and Other Research Animals Huw Golledge, Claire Richardson, 2024-04-15 The UFAW Handbook on The Care and Management of Laboratory and Other Research Animals The latest edition of the seminal reference on the care and management of laboratory and research animals The newly revised ninth edition of The UFAW Handbook on the Care and Management of Laboratory and Other Research Animals delivers an up-to-date and authoritative exploration on worldwide developments, current thinking, and best practices in the field of laboratory animal welfare science and technology. The gold standard in laboratory and captive animal care and management references, this latest edition continues the series’ tradition of excellence by including brand-new chapters on ethical review, the care of aged animals, and fresh guidance on the care of mole rats, corvids, zebrafish, and decapods. The book offers introductory chapters covering a variety of areas of laboratory animal use, as well as chapters on the management and care of over 30 different taxa of animals commonly utilised in scientific procedures and research around the world. It also provides: A thorough introduction to the design of animal experiments, laboratory animal genetics, and the phenotyping of genetically modified mice Comprehensive explorations of animal welfare assessment and the ethical review process Practical discussions of legislation and oversight of the conduct of research using animals from a global perspective In-depth examinations of the planning, design, and construction of efficient animal facilities, special housing arrangements, and nutrition, feeding, and animal welfare The UFAW Handbook on the Care and Management of Laboratory and Other Research Animals Ninth Edition is essential for laboratory animal scientists, veterinarians, animal care staff, animal care regulatory authorities, legislators, and professionals working in animal welfare non-governmental organizations.
  nonhuman biologics definition: Biosimilar Drug Product Development Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow, 2017-02-24 When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
  nonhuman biologics definition: Management of Animal Care and Use Programs in Research, Education, and Testing Robert H. Weichbrod, Gail A. (Heidbrink) Thompson, John N. Norton, 2017-09-07 AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).
  nonhuman biologics definition: Xenotransplantation Daniel J. Hurst, Luz Padilla, Wayne D. Paris, 2023-06-21 This is the first volume to comprehensively discuss the ethical, regulatory, and social aspects of xenotransplantation research. Organized into four parts, Xenotransplantation begins by examining ethical issues around informed consent of the potential xenograft recipient, the major ethical issues encountered when doing this research on pigs, and allocation issues. Part two examines regulatory aspects from a global perspective, specifically from three major regions of the world doing xenotransplantation research currently, of which include the United States, Western Europe, and Asia. Following this, part three describes religious aspects of xenotransplantation amongst the major world religions, including Christianity, Islam, Judaism, and Hinduism. The book closes with an analysis of quantitative and qualitative studies conducted by the editors that assess the public’s perception of xenotransplantation. Featuring original data collected by the editors, this book is an instrumental resource for all clinicians involved in the research and practice of xenotransplantation.
  nonhuman biologics definition: Reform and Innovation of Science and Education United States. Congress. Senate. Committee on Agriculture, Nutrition, and Forestry, 1989