The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment

Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
Publisher : Academic Press
Page : 716 pages
File Size : 51,6 Mb
Release : 2015-03-13
Category : Medical
ISBN : 9780124171466

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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment by Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer Pdf

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

Author : Gerhard F. Weinbauer,Friedhelm Vogel
Publisher : Waxmann Verlag
Page : 180 pages
File Size : 51,6 Mb
Release : 2013
Category : Medical
ISBN : 9783830978398

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Challenges in Nonhuman Primate Research in the 21st Century by Gerhard F. Weinbauer,Friedhelm Vogel Pdf

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.

Author : William J. Brock,Kenneth L. Hastings,Kathy M. McGown
Publisher : John Wiley & Sons
Page : 492 pages
File Size : 54,7 Mb
Release : 2013-03-05
Category : Medical
ISBN : 9781118516980

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Nonclinical Safety Assessment by William J. Brock,Kenneth L. Hastings,Kathy M. McGown Pdf

Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1020 pages
File Size : 53,6 Mb
Release : 2003-09-05
Category : Medical
ISBN : 9780471459293

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Drug Safety Evaluation by Shayne Cox Gad Pdf

Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 918 pages
File Size : 42,9 Mb
Release : 2016-12-01
Category : Medical
ISBN : 9781119097419

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Drug Safety Evaluation by Shayne Cox Gad Pdf

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Author : Carrie Markgraf,Thomas Hudzik,David Compton
Publisher : Academic Press
Page : 320 pages
File Size : 52,5 Mb
Release : 2015-07-14
Category : Medical
ISBN : 9780124202160

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Nonclinical Assessment of Abuse Potential for New Pharmaceuticals by Carrie Markgraf,Thomas Hudzik,David Compton Pdf

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability. Provides a consolidated overview of the complex regulatory landscape Offers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studies Includes real-life examples to illustrate how nonclinical data fit into the submission strategy

Author : Joy A. Cavagnaro
Publisher : John Wiley & Sons
Page : 1012 pages
File Size : 47,7 Mb
Release : 2013-03-07
Category : Medical
ISBN : 9781118679388

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Preclinical Safety Evaluation of Biopharmaceuticals by Joy A. Cavagnaro Pdf

"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.

Author : Ali S. Faqi
Publisher : Elsevier
Page : 1074 pages
File Size : 47,5 Mb
Release : 2024-02-11
Category : Medical
ISBN : 9780323984621

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A Comprehensive Guide to Toxicology in Nonclinical Drug Development by Ali S. Faqi Pdf

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

Author : Mary Jeanne Kallman,Michael Pugsley
Publisher : Academic Press
Page : 0 pages
File Size : 45,9 Mb
Release : 2018-09-07
Category : Medical
ISBN : 0128122064

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Advanced Issue Resolution in Safety Pharmacology by Mary Jeanne Kallman,Michael Pugsley Pdf

Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.

Author : Pritam S. Sahota,James A. Popp,Jerry F. Hardisty,Chirukandath Gopinath
Publisher : CRC Press
Page : 987 pages
File Size : 41,7 Mb
Release : 2013-04-09
Category : Medical
ISBN : 9781439872123

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Toxicologic Pathology by Pritam S. Sahota,James A. Popp,Jerry F. Hardisty,Chirukandath Gopinath Pdf

As drug development shifts over time to address unmet medical needs and more targeted therapies are developed, previously unseen pharmacological or off-target effects may occur in treatment. Designed to provide practical information for the bench toxicologic pathologist working in pharmaceutical drug research, Toxicologic Pathology: Nonclinical Saf

Author : Huifang Chen
Publisher : Unknown
Page : 0 pages
File Size : 52,7 Mb
Release : 2021
Category : Primates as laboratory animals
ISBN : 1536194409

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Nonhuman Primate Models in Preclinical Research by Huifang Chen Pdf

"Due to the phylogenetic relationship and close genetic and biological similarities with humans, non-human primates (NHP) are regularly used in biomedical and behavioural research. However, because of their highly developed cognitive abilities and social skills, the use of these animals in biomedical research is debated more and more. Although it is acknowledged that in specific research areas NHP are still essential, it is recognized that the use of these animals can only be done under strict conditions under the most optimal welfare aspects. Welfare aspects include housing conditions, non-invasive methods and application of the 3Rs policy. Although many refinement methods have been described in nationally and internationally accepted guidelines on animal laboratory practice, recognition of the guidelines is unfortunately not universal. The present book covers a wide range of NHP models in preclinical research and welfare issues. The following chapters will cover: refinement of the use of NHP in biomedical research; NHP ethics and regulations in Europe; biological basis differences in the human and NHP; the major histocompatibility complex (MHC) immunology in NHP; stem cell biology in NHP; neuro and gliogenesis in an NHP ischemia stroke model; NHP models in autoimmune disease, organ transplantation and infectious disease research; viral diseases in NHP; NHP models in Parkinson's disease, in neurodegenerative disorders research and in cardio-cerebrovascular disease research; islet transplantation; ophthalmic diseases research and neurophysiology in NHP; transgenic engineering in NHP; NHP models of cancers; NHP models in respiratory disease research; NHP models in clinical and non-clinical pharmacology; NHP models in lung transplantation; and aging research in NHP. This book encapsulates a large volume of knowledge scientists have achieved in the field of nonhuman primate models in preclinical research. The editors have invited experts from the United States, Canada, and Europe to contribute 23 chapters in their respective fields of their expertise"--

Author : Jeffrey D. Fortman,Terry A. Hewett,Lisa C. Halliday
Publisher : CRC Press
Page : 328 pages
File Size : 43,9 Mb
Release : 2017-10-23
Category : Medical
ISBN : 9781351643276

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The Laboratory Nonhuman Primate by Jeffrey D. Fortman,Terry A. Hewett,Lisa C. Halliday Pdf

Key features Contains 28 updated tables designed as quick, easy-to-use references for New and Old World species Provides over 100 photographs and illustrations, most now in color, depicting aspects of nonhuman primate biology, behavior, management practices, diseases, and technical procedures Gives a concise overview of regulatory considerations for the use of nonhuman primates in biomedical research Expands the Veterinary Care chapter to include new sections on nutritional support, behavioral conditions, dental care, and updated information on anesthetic and analgesic drugs Presents step-by-step descriptions of common and advanced sampling techniques Includes extensive resource lists for vendors of animals, feed, sanitation supplies, caging, anesthetic equipment, and veterinary and research supplies Extensively updated to include current literature, The Laboratory Nonhuman Primate, Second Edition, continues to serve as a quick reference source for technicians, caretakers, veterinarians, researchers, and students working with primates in biomedical research. It provides details on basic husbandry and covers biologic characteristics, regulatory compliance, common diseases, and anesthetic management. The text gives easy-to-follow descriptions of basic technical procedures including restraint, intubation, tuberculin skin testing, and collection of blood and urine samples. It also reviews advanced sampling procedures including collection of bone marrow, cerebrospinal fluid, bronchoalveolar lavage fluid, and rectal mucosal biopsy. The Laboratory Nonhuman Primate presents information in a clear, concise format to allow readers to incorporate concepts and techniques into the standard operating procedures of a facility.

Author : Alys Bradley,Jennifer Chilton,Beth Mahler
Publisher : Academic Press
Page : 628 pages
File Size : 53,7 Mb
Release : 2023-06-20
Category : Science
ISBN : 9780128130896

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Spontaneous Pathology of the Laboratory Non-human Primate by Alys Bradley,Jennifer Chilton,Beth Mahler Pdf

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

Author : Anonim
Publisher : Unknown
Page : 24 pages
File Size : 40,5 Mb
Release : 1995
Category : Drugs
ISBN : MINN:31951D013437920

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Toxicokinetics by Anonim Pdf

Author : P.V. Mohanan
Publisher : Woodhead Publishing
Page : 808 pages
File Size : 54,6 Mb
Release : 2022-01-22
Category : Technology & Engineering
ISBN : 9780128241738

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Biomedical Product and Materials Evaluation by P.V. Mohanan Pdf

Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies Discusses standardization and ethical hurdles in biomedical product development and how to overcome them