Download or read book Guideline for the Format and Content of the Nonclinical Pharmacology toxicology Section of an Application written by Center for Drugs and Biologics (U.S.) and published by . This book was released on 1987 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline for the Format and Content of the Nonclinical Pharmacology toxicology Section of an Application written by and published by . This book was released on 1987 with total page 27 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Draft Guideline for the Format and Content of the Nonclinical Pharmacology toxicology Section of an Application written by Center for Drugs and Biologics (U.S.) and published by . This book was released on 1985 with total page 29 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline on Formatting Assembling and Submitting New Drug and Antibiotic Applications written by DIANE Publishing Company and published by DIANE Publishing. This book was released on 1998-04 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline on Formatting Assembling and Submitting New Drug and Antibiotic Applications written by and published by . This book was released on 1987 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.
Download or read book Nonclinical Safety Assessment written by William J. Brock and published by John Wiley & Sons. This book was released on 2013-03-05 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 Toxicokinetics written by and published by . This book was released on 1995 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Development written by Charles E. Hamner and published by CRC Press. This book was released on 2019-06-12 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development.
Download or read book Handbook of Pharmaceutical Salts Properties Selection and Use written by P. Heinrich Stahl and published by John Wiley & Sons. This book was released on 2008-08-04 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.
Download or read book Handbook of Nutraceuticals Volume I written by Yashwant Vishnupant Pathak and published by CRC Press. This book was released on 2009-11-24 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: As soon as Dr. Stephen DeFelice coined the phrase nutraceutical, product and supplement developers swung into action. Yet among the numerous books available on nutraceuticals, there is none that systematically lists, categorizes, and analyzes nutraceutical extracts and formulations in a pharmacopoeia-like manner. Handbook of Nutraceuticals, Volume
Download or read book Preclinical Development Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-21 with total page 1352 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.
Download or read book Federal Register written by and published by . This book was released on 2013-12 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Statistics In the Pharmaceutical Industry written by C. Ralph Buncher and published by CRC Press. This book was released on 2019-03-07 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.
Download or read book Statistics In the Pharmaceutical Industry 3rd Edition written by Charles Ralph Buncher and published by CRC Press. This book was released on 1993-11-17 with total page 606 pages. Available in PDF, EPUB and Kindle. Book excerpt: This rewritten and updated second edition provides comprehensive information on the wide-ranging applications of statistics in the pharmacological field. Focusing on practical aspects, it sets out to bridge the gap between industry and academia.;Reflecting the changes that have taken place since publication of the first edition, this volume covers new topics such as: cancer clinical trials, clinical trials of AIDS patients and animal tumorigenicity studies; the development of antiepileptic drugs; the role of epidemiology in postmarketing trials and adverse drug experience; computer-assisted new drug application (CANDA) submissions; contract research organizations; interim analysis in clinical trials; and room-temperature tests for the stability of drugs.;This work is intended as: a reference for statisticians, biostatisticians, pharmacologists, administrators, managers, and scientists in the pharmaceutical industry; and a text for graduate students taking courses in applied statistics or pharmaceutical statistics.
Download or read book Principles of Clinical Pharmacology written by Arthur J. Atkinson Jr. and published by Gulf Professional Publishing. This book was released on 2001 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rate of introduction of new pharmaceutical products has increased rapidly over the past decade, and details learned about a particular drug become obsolete as it is replaced by newer agents. For this reason, this book focuses on the principles that underlie the clinical use and contemporary development of pharmaceuticals. The coverage of these principles that is presented in this book will be of particular benefit to individuals engaged either in the teaching or study of sound therapeutic technique or in the investigation of pharmacological agents. Key Features * Unique breadth of coverage ranging from drug discovery and development to individualization and quality assessment of drug therapy * Unusual cohesiveness of presentation that stems from author participation in an ongoing popular NIH course * Instructive linkage of pharmacokinetic theory and applications with provision of sample problems for self-study * Wide-ranging perspective of authors drawn from the ranks of Federal agencies, academia and the pharmaceutical industry
Download or read book Monthly Catalog of United States Government Publications written by and published by . This book was released on 1987 with total page 1476 pages. Available in PDF, EPUB and Kindle. Book excerpt:
