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| nonhuman biologics definition: Nonhuman Primates and Medical Research Geoffrey H. Bourne, 2014-05-10 Nonhuman Primates and Medical Research focuses on the contributions of nonhuman primates to biomedical research. The selection first elaborates on monkeys and yellow fever, cell cultures, and tuberculosis and bacterial infection. Discussions focus on bacterial diseases, tuberculosis, radiobiology, antibody formation and pharmacologic studies, cell-culture media and methods, the rhesus monkey and early history of yellow fever research, and monkeys and yellow fever in the future. The text then elaborates on virus research, models for investigation in parasitology, and primates as organ donors in transplantation studies in man. The manuscript examines the importance of monkeys for the study of malignant tumors in man; use of primates in cardiovascular research; and humanlike diseases in anthropoid apes. Topics include etiology of humanlike disease in anthropoid apes, atherosclerosis, historical aspects of primate research, selection of a suitable primate, and preeclampsia. The text also ponders on primate studies and human evolution and mental retardation. The selection is a valuable reference for researchers interested in the contributions of nonhuman primates to biomedical research. |
| nonhuman biologics definition: Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics Lisa M. Plitnick, Danuta Herzyk, 2013-06-27 Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. - Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical - Contains the most pertinent international regulatory guidance documents for nonclinical evaluation - Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or biosimilars - A multi-authored book with chapters written by qualified experts in their respective fields |
| 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: 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: 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, 2003-07-13 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: The Immune Response to Therapeutic Antibodies Daniel T. Mytych, Michael Tovey, Arno J. Kromminga, 2025-02-25 Therapeutic antibodies have revolutionized the treatment of numerous serious diseases in particular chronic diseases with a complex physiopathology such as cancer, autoimmune, and inflammatory disorders. Therapeutic antibodies are also used to treat acute diseases such as COVID-19. Although, the use of therapeutic antibodies has led to considerable progress in the treatment of numerous diseases, such therapies are often associated with adverse events and loss of the therapeutic response due in part to an undesired immune response to the therapeutic agent. |
| nonhuman biologics definition: Nonhuman Primates in Biomedical Research , 1998-07-24 This volume and its companion Nonhuman Primates in Biomedical Research: Biology and Management represent the most comprehensive publications of their type on nonhuman primates. This volume addresses the diseases of nonhuman primates with an emphasis on the etiological factors, clinical signs, diagnostic pathology, therapy, and management. Its companion volume serves as a general reference for those who provide care for these animals and for those who use them in biomedical research. |
| nonhuman biologics definition: Toxicologic Pathology for Non-Pathologists Thomas J. Steinbach, Daniel J. Patrick, Mary Ellen Cosenza, 2019-10-31 This extensive volume began as a short course primarily geared toward toxicologists who want to expand their understanding of toxicologic pathology in order to be better study directors while also proving to be of great interest to other drug development scientists and regulatory reviewers. The overall goal is to help non-pathologists understand, contextualize, and communicate the pathology data and interpretations from the study pathologist in a practical and usable format. Within the book, readers will find an overview of general pathology concepts that include fundamental vocabulary and the basics of pathophysiological processes, along with numerous chapters devoted to pathology in specific organ systems as well as topics such as biomarkers, correlation of clinical pathology endpoints (chemistry and hematology) with microscopic changes, and well-known pathology findings for classes of toxic substances. Authoritative, practical, and comprehensive, Toxicologic Pathology for Non-Pathologists aims to help non-pathologists understand, converse in, and apply a basic understanding of pathology in their day-to-day careers. |
| 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: Massive and Irreparable Rotator Cuff Tears Nuno Sampaio Gomes, Ladislav Kovačič, Frank Martetschläger, Giuseppe Milano, 2020-04-22 This book offers a truly comprehensive overview of the understanding and treatment of massive and irreparable rotator cuff tears, a painful and disabling shoulder condition that continues to pose major challenges. A thorough examination of basic science issues and evidence lays the foundation for discussion of key controversies in the field and exposition of a practical approach to treatment in which the role of both conservative and surgical management is explained. Special insights are provided into the new biological and nonoperative approaches that are becoming increasingly popular among practitioners. All potential surgical techniques are described, from partial repair and tendon transfer, to the use of dedicated implants. In addition, the value of anesthesia and regional blocks, both during surgery and in the postoperative phase, is discussed. The concluding section addresses particularly complex scenarios and offers guidance on the management of treatment complications and failures. Written by leading international shoulder experts, the book will be of value for shoulder surgeons, rehabilitators, and other health care practitioners. |
| nonhuman biologics definition: Biologics and Biosimilars Xiaodong Feng, Hong-Guang Xie, Ashim Malhotra, Catherine F. Yang, 2022-06-13 Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs. |
| nonhuman biologics definition: Challenges in Nonhuman Primate Research in the 21st Century Gerhard F. Weinbauer, Friedhelm Vogel, 2013 In continuation of the Covance Primate Symposium Series, the 19th Covance Primate Symposium took place in Münster on 23rd & 24th of May 2012. Altogether, 70 participants representing 43 organisations, gathered for this symposium. The 2012 Primate Symposium focussed on ?Challenges in Nonhuman Primate Research in the 21st Century?. The broad participation and the lively discussions during the symposium underlined the timeliness and importance of this topic. Expert speakers covered four major topics, i.e. biosimilars development: regulatory implications, key considerations and next steps, optimizing nonhuman primate use in nonclinical safety assessment, trends in nonhuman primate developmental & reproductive toxicology (DART) and juvenile toxicity evaluation, and relevance and importance of nonhuman primate models in regulatory toxicology. The development of biosimilar has taken up speed considerably and meanwhile needs to be considered a significant factor of potential drug development, yet there are still some uncertainties und guidelines are under development. With the increased focus on biopharmaceuticals and the associated increase for using nonhuman primates being the relevant animal model, it became necessary to optimize the use of this animal model, e.g. refine study designs and animals numbers but still execute meaningful preclinical studies. It appears that significant progress has been achieved in that context. In the area of nonhuman primate DART and juvenile toxicity evaluation, recent guideline changes had a major impact on species selection, and the experimental design plus the timing of these studies within the preclinical programmes. Finally, given the increasing regulations and justficiations of using nonhuman primates as experimental models. It is paramount to understand the essential and indispensable role that nonhuman primates can play in drug safety evaluation and medical drug development. |
| nonhuman biologics definition: Nonhuman Primates in Biomedical Research Christian R. Abee, Keith Mansfield, Suzette D. Tardif, Timothy Morris, 2012-03-29 A comprehensive, up-to-date review of the use of nonhuman primates in biomedical research, emphasising the biology and management, diseases, and biomedical models for nonhuman primate species most commonly used in research. |
| 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: Nutrient Requirements of Nonhuman Primates National Research Council, Division on Earth and Life Studies, Board on Agriculture and Natural Resources, Ad Hoc Committee on Nonhuman Primate Nutrition, Committee on Animal Nutrition, 2003-03-01 This new release presents the wealth of information gleaned about nonhuman primates nutrition since the previous edition was published in 1978. With expanded coverage of natural dietary habits, gastrointestinal anatomy and physiology, and the nutrient needs of species that have been difficult to maintain in captivity, it explores the impact on nutrition of physiological and life-stage considerations: infancy, weaning, immune function, obesity, aging, and more. The committee also discusses issues of environmental enrichment such as opportunities for foraging. Based on the world's scientific literature and input from authoritative sources, the book provides best estimates of nutrient requirements. The volume covers requirements for energy: carbohydrates, including the role of dietary fiber; proteins and amino acids; fats and fatty acids; minerals, fat-soluble and water-soluble vitamins; and water. The book also analyzes the composition of important foods and feed ingredients and offers guidelines on feed processing and diet formulation. |
| 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: Nonclinical Development of Biologics, Vaccines and Specialty Biologics Lisa M. Plitnick, Claudette L. Fuller, 2024-11-16 Nonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics, Second Edition is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. Updated and revised, the new edition compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory guidelines. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. A multi-edited book with chapters authored by leading qualified experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late-stage biologics. - Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical - Discusses the most pertinent international regulatory guidelines - Covers early derisking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines |
| nonhuman biologics definition: Ecology, Writing Theory, and New Media Sidney Dobrin, 2011-12-22 Moving beyond ecocomposition, this book galvanizes conversations in ecology and writing not with an eye toward homogenization, but with an agenda of firmly establishing the significance of writing research that intersects with ecology. It looks to establish ecological writing studies not just as a legitimate or important form of writing research, but as paramount to the future of writing studies and writing theory. Complex ecologies, writing studies, and new-media/post-media converge to highlight network theories, systems theories, and posthumanist theories as central in the shaping of writing theory, and this study embraces work in these areas as essential to the development of ecological theories of writing. Contributors address ecological theories of writing by way of diverse and promising avenues, united by the underlying commitment to better understand how ecological methodologies might help better inform our understanding of writing and might provoke new theories of writing. Ecology, Writing Theory, and New Media fuels future theoretical conversations about ecology and writing and will be of interest to those who are interested in theories of writing and the function of writing. |
| nonhuman biologics definition: Spontaneous Pathology of the Laboratory Non-human Primate Alys Bradley, Jennifer Chilton, Beth Mahler, 2023-06-20 Spontaneous Pathology of the Laboratory Non-human Primate serves as a go to resource for all pathologists working on primates in safety assessment studies. In addition, it helps diagnostic veterinary pathologists rule out spontaneous non-clinical disease pathologies when assigning cause of death to species in zoological collections. Primate species included are rhesus, cynomolgus macaques and marmosets. Multi-authored chapters are arranged by organ system, thus providing the necessary information for continued research.Pathologists often face a lack of suitable reference materials or historical data to determine if pathologic changes they are observing in monkeys are spontaneous or a consequence of other treatments or factors. - Contains color illustrations that depict the most common lesions to augment descriptions - Covers descriptions that are compliant with the International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) guidelines set forth by the Society of Toxicologic Pathology (STP) - Provides pathologists with common terms that are compliant with the FDA's Standard for Exchange of Nonclinical Data (SEND) guidelines |
| nonhuman biologics definition: Targeted Treatment of the Rheumatic Diseases Michael H. Weisman, 2010-01-01 Michael H. Weisman, Michael Weinblatt, James S Louie, and Ronald Van Vollenhoven offer their unique insights into choosing the correct pharmacological and non-pharmacological therapies for your patients. Chapters cover the full breadth of rheumatic diseases, rheumatoid arthritis, lupus, connective tissue diseases, osteoporosis, regional pain disorders, and fibromyalgia. The full-color design presents detailed clinical photographs and treatment algorithms for visual guidance and easy reference. Covers the treatment of pediatric patients as well as adults so that you can properly address the particular needs of any patient you see. Features the guidance and specific recommendations of experts from United States and Europe for a state-of-the-art approach to the variety of treatments currently in use. Displays the clinical manifestations of rheumatic diseases in full color, along with treatment algorithms for easy at-a-glance reference. |
| nonhuman biologics definition: Biologic Markers in Urinary Toxicology National Research Council, Division on Earth and Life Studies, Commission on Life Sciences, Subcommittee on Biologic Markers in Urinary Toxicology, 1995-07-28 Diseases of the kidney, bladder, and prostate exact an enormous human and economic toll on the population of the United States. This book examines prevention of these diseases through the development of reliable markers of susceptibility, exposure, and effect and the promise that new technologies in molecular biology and sophisticated understanding of metabolic pathways, along with classical approaches to the study of nephrotoxicants and carcinogens, can be developed and prevention of the diseases achieved. The specific recommendations included in this book complement those made in the previous three volumes on biomarkers, Biologic Markers in Reproductive Toxicology (1989), Biologic Markers in Pulmonary Toxicology (1989), and Biologic Markers in Immunotoxicology (1991). |
| nonhuman biologics definition: Nonhuman Primates Institute of Laboratory Animal Resources (U.S.). Committee on Conservation of Nonhuman Primates, 1975 |
| nonhuman biologics definition: Stem Cells in Regenerative Medicine Alain A. Vertes, Nasib Qureshi, Arnold I. Caplan, Lee E. Babiss, 2015-12-02 This book is a unique guide to emerging stem cell technologies and the opportunities for their commercialisation. It provides in-depth analyses of the science, business, legal, and financing fundamentals of stem cell technologies, offering a holistic assessment of this emerging and dynamic segment of the field of regenerative medicine. • Reviews the very latest advances in the technology and business of stem cells used for therapy, research, and diagnostics • Identifies key challenges to the commercialisation of stem cell technology and avenues to overcome problems in the pipeline • Written by an expert team with extensive experience in the business, basic and applied science of stem cell research This comprehensive volume is essential reading for researchers in cell biology, biotechnology, regenerative medicine, and tissue engineering, including scientists and professionals, looking to enter commercial biotechnology fields. |
| 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: Size Matters Johann S. Ach, 2008 Nanotechnologies and nanobiotechnologies will come to be the key technologies of the 21st century. The possibility to study, understand and control features of materials at the nanoscale promises developments in different areas ranging from material sciences to electronics and communication technologies or life sciences and medicine. If one wants to make good use of nanotechnological research and development one has to create an environment that meets the various ethical, legal and social challenges as well. |
| nonhuman biologics definition: Remington Adeboye Adejare, 2020-11-03 The PCP's Bicentennial Edition Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics. - Contains a comprehensive source of principles of drug discovery and development topics, especially for scientists that are new in the pharmaceutical industry such as those with trainings/degrees in chemistry and engineering - Provides a detailed source for formulation scientists and compounding pharmacists, from produg to excipient issues - Updates this excellent source with the latest information to verify facts and refresh on basics for professionals in the broadly defined pharmaceutical industry |
| 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: Food Safety of Proteins in Agricultural Biotechnology Bruce G. Hammond, 2007-11-28 With contributions from internationally recognized experts, Food Safety of Proteins in Agricultural Biotechnology comprehensively addresses how toxicology testing of proteins should be accomplished and how protein safety assessments should be carried out. Beginning with a background on protein biology, the book delineates the fundamental difference |
| nonhuman biologics definition: Nonhuman Primates National Academy of Sciences (U.S.), 1975 |
| nonhuman biologics definition: Progress and challenges in computational structure-based design and development of biologic drugs Traian Sulea, Sandeep Kumar, Daisuke Kuroda, 2024-03-25 |
| nonhuman biologics definition: Pediatric Non-Clinical Drug Testing Alan M. Hoberman, Elise M. Lewis, 2011-12-28 This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource. |
| nonhuman biologics definition: A Comprehensive Guide to Toxicology in Nonclinical Drug Development Ali S. Faqi, 2024-02-11 A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy - Includes the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology |
| nonhuman biologics definition: The Principles of Biomedical Instrumentation Stanley A. Rubin, 1987 |
| nonhuman biologics definition: National Institutes of Health Annual Report of International Activities John E. Fogarty International Center for Advanced Study in the Health Sciences, 1981 |
| nonhuman biologics definition: Preclinical Drug Development Mark Rogge, David R. Taft, 2016-04-19 Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: PharmacokineticsModeling and simula |
| nonhuman biologics definition: Federal Register , 1979-06 |
| nonhuman biologics definition: Biotechnology Law for the 1990s , 1989 |
| nonhuman biologics definition: Handbook of Ecosystem Theories and Management Felix Muller, 2000-02-10 As part of the Environmental and Ecological Modeling Handbooks series, the Handbook of Ecosystem Theories and Management provides a comprehensive overview of ecosystem theory and the tools - ecological engineering, ecological modeling, ecotoxicology and ecological economics -to manage these systems. The book is laid out to provide a summary or |
| nonhuman biologics definition: Research Needs for Radiation Protection National Council on Radiation Protection and Measurements. Scientific Committee 83, 1993 |
| nonhuman biologics definition: Nonhuman Primates National Research Council (U.S.). Committee on Conservation of Nonhuman Primates, 1975 |
Non-human - Wikipedia
Non-human (also spelled nonhuman) is any entity displaying some, [1] but not enough, human characteristics to be considered a human. The term has been used in a variety of contexts and …
NONHUMAN Definition & Meaning - Merriam-Webster
The meaning of NONHUMAN is not human. How to use nonhuman in a sentence. not human: such as; being other than a human being; not belonging to, appropriate to, or produced by …
NONHUMAN Definition & Meaning | Dictionary.com
not displaying the emotions, sympathies, intelligence, etc., of most human beings. not intended for consumption by humans. nonhuman products such as soaps and detergents. The media could …
NONHUMAN definition and meaning | Collins English Dictionary
Nonhuman means not human or not produced by humans. Hostility towards outsiders is characteristic of both human and nonhuman animals. Collins COBUILD Advanced Learner’s …
non-human - Oxford Learner's Dictionaries
Definition of non-human adjective in Oxford Advanced Learner's Dictionary. Meaning, pronunciation, picture, example sentences, grammar, usage notes, synonyms and more.
Nonhuman - Definition, Meaning & Synonyms | Vocabulary.com
DISCLAIMER: These example sentences appear in various news sources and books to reflect the usage of the word ‘nonhuman'. Views expressed in the examples do not represent the opinion …
What does Nonhuman mean? - Definitions.net
Nonhuman refers to any entity, being, or creature that is not a member of the human species. It encompasses animals, plants, machines, extraterrestrial life, supernatural beings, artificial …
Nonhuman | Transid.org
Feb 2, 2025 · Nonhuman is an umbrella term to describe someone or something that is fully or partially not human. This can include a wide array of species, including animals, plants, …
Nonhuman - definition of nonhuman by The Free Dictionary
nonhuman - not human; not belonging to or produced by or appropriate to human beings; "nonhuman primates such as chimpanzees"
The Real Human-Nonhuman Difference - Psychology Today
Mar 21, 2014 · Humans do different things. Animals don’t. Pick any individual animal at random and ask what it’s doing right now. You couldn’t know, but without knowing you could give a …
Non-human - Wikipedia
Non-human (also spelled nonhuman) is any entity displaying some, [1] but not enough, human characteristics to be considered a human. The term has been used in a variety of contexts and …
NONHUMAN Definition & Meaning - Merriam-Webster
The meaning of NONHUMAN is not human. How to use nonhuman in a sentence. not human: such as; being other than a human being; not belonging to, appropriate to, or produced by …
NONHUMAN Definition & Meaning | Dictionary.com
not displaying the emotions, sympathies, intelligence, etc., of most human beings. not intended for consumption by humans. nonhuman products such as soaps and detergents. The media could …
NONHUMAN definition and meaning | Collins English Dictionary
Nonhuman means not human or not produced by humans. Hostility towards outsiders is characteristic of both human and nonhuman animals. Collins COBUILD Advanced Learner’s …
non-human - Oxford Learner's Dictionaries
Definition of non-human adjective in Oxford Advanced Learner's Dictionary. Meaning, pronunciation, picture, example sentences, grammar, usage notes, synonyms and more.
Nonhuman - Definition, Meaning & Synonyms | Vocabulary.com
DISCLAIMER: These example sentences appear in various news sources and books to reflect the usage of the word ‘nonhuman'. Views expressed in the examples do not represent the opinion …
What does Nonhuman mean? - Definitions.net
Nonhuman refers to any entity, being, or creature that is not a member of the human species. It encompasses animals, plants, machines, extraterrestrial life, supernatural beings, artificial …
Nonhuman | Transid.org
Feb 2, 2025 · Nonhuman is an umbrella term to describe someone or something that is fully or partially not human. This can include a wide array of species, including animals, plants, …
Nonhuman - definition of nonhuman by The Free Dictionary
nonhuman - not human; not belonging to or produced by or appropriate to human beings; "nonhuman primates such as chimpanzees"
The Real Human-Nonhuman Difference - Psychology Today
Mar 21, 2014 · Humans do different things. Animals don’t. Pick any individual animal at random and ask what it’s doing right now. You couldn’t know, but without knowing you could give a …
