Download or read book Addendum to ICH S6 written by and published by . This book was released on 2009 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Addendum to ICH S6 written by and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Nonclinical Safety Assessment written by William J. Brock and published by John Wiley & Sons. This book was released on 2013-04-29 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Developmental and Reproductive Toxicology written by Ronald D Hood and published by CRC Press. This book was released on 2016-04-19 with total page 872 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, Developmental and Reproductive Toxicology: A Practical Approach, Second Edition draws together valuable information typically scattered throughout the literature, plus some not previously published, into one complete resource. In addition to the traditional aspects of developmental toxicity testing, the book covers e
Download or read book Global Approach in Safety Testing written by Jan Willem van der Laan and published by Springer Science & Business Media. This book was released on 2013-02-11 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.
Download or read book Development of Antibody Based Therapeutics written by Mohammad A. Tabrizi and published by Springer Science & Business Media. This book was released on 2012-04-24 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational strategies for development of antibody-based therapeutics should allow understanding of the relationship between the ‘unit dose’ and ‘unit effect’ with respect to both beneficial and deleterious effects from early stages of development. The flow of information from later to earlier stages of development should provide opportunities to facilitate selection of more effective novel and next-generation drug candidates. Selection and evaluation of relevant biomarkers in early preclinical development in "relevant" animal models should allow for identifying potential risks to humans and establishing safe First-In-Human (FIH) dosing strategies. Hence, integration of knowledge with respect to target antigen properties such as antigen distribution, expression profile, kinetic properties, target pharmacology, antigen isoforms and pharmacological redundancy in health and disease, as well as antibody design criteria, such as antibody isotype, affinity, PK/PD and safety is a critical necessity for the design of effective translational strategies. Additionally, these factors will further offer critical differentiating characteristics for next-generation antibodies, and novel technologies prove instrumental in generation of biosuperior antibody candidates for market entry. This book will examine many important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics.
Download or read book Toxicologic Pathology written by Pritam S. Sahota and published by CRC Press. This book was released on 2018-08-14 with total page 1776 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.
Download or read book Biological Drug Products written by Wei Wang and published by John Wiley & Sons. This book was released on 2013-08-29 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Download or read book Good Clinical Practice eRegs Guides For Your Reference Book 6 written by eRegs & Guides and published by eregs & guides. This book was released on 2013-11-22 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: ICH - Safety Guidelines S1A – S9 S1A Guideline on the Need for Carcinogenicity Studies S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) S5(R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S7A Safety Pharmacology Studies For Human Pharmaceuticals S7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals S8 Immunotoxicity Studies for Human Pharmaceuticals S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
Download or read book Assessing Ocular Toxicology in Laboratory Animals written by Andrea B Weir and published by Springer Science & Business Media. This book was released on 2012-12-04 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ocular toxicity is routinely assessed in toxicology studies conducted for regulatory purposes. Ocular anatomy and physiology and the assessment of ocular toxicity itself can be challenging to scientists involved in the safety assessment of pharmaceuticals, pesticides and other agents. Anatomical and physiological differences between species can impact the nature of ocular effects observed following intended or unintended exposure of ocular tissues to xenobiotics. Ocular Toxicity in Laboratory Animals provides a concise reference addressing ocular anatomy and physiology across species that will enhance the design and interpretation of toxicology studies conducted for regulatory purposes. The book provides an overview of routine and advanced techniques that are used to assess ocular toxicity including slit lamp biomicroscopy, indirect ophthalmoscopy, electrophysiology and imaging methods for the anterior and posterior segments of the eye. Additionally, the book defines the regulatory expectations for pharmaceuticals intended to treat ocular diseases and for other non-pharmaceutical regulated chemicals. With contributions from experts in the field, Ocular Toxicity in Laboratory Animals is an authoritative, accessible guide for toxicologists and other scientists involved in conducting toxicology studies for regulatory purposes and/or reviewing data from such studies.
Download or read book Nonhuman Primates in Biomedical Research Two Volume Set written by Christian R. Abee and published by Academic Press. This book was released on 2012-12-31 with total page 3435 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment written by Joerg Bluemel and published by Academic Press. This book was released on 2015-03-13 with total page 716 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The Role of the Study Director in Nonclinical Studies written by William J. Brock and published by John Wiley & Sons. This book was released on 2014-05-02 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
Download or read book Food Safety of Proteins in Agricultural Biotechnology written by Bruce G. Hammond and published by CRC Press. This book was released on 2007-11-28 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Federal Register written by and published by . This book was released on 2013-03 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics written by Lisa M. Plitnick and published by Academic Press. This book was released on 2013-06-27 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
