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Statistical Evaluation Of Mutagenicity Test Data

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Statistical Evaluation Of Mutagenicity Test Data

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Author : United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing
language : en
Publisher: Cambridge University Press
Release Date : 1989-12-07

Statistical Evaluation Of Mutagenicity Test Data written by United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1989-12-07 with Medical categories.

This rigorous and practical account of the interpretation of mutagenicity test data draws upon the expertise of toxicologists and statisticians. Chemicals, such as drugs, food additives and pesticides, all need careful screening to eliminate potentially mutagenic compounds.

Statistical Evaluation Of Mutagenicity Test Data

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Author : David J. Kirkland
language : en
Publisher: Cambridge University Press
Release Date : 2008-01-03

Statistical Evaluation Of Mutagenicity Test Data written by David J. Kirkland and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-01-03 with Medical categories.

Statistical Evaluation Of Mutagenicity Test Data

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Author :
language : en
Publisher:
Release Date : 1989

Statistical Evaluation Of Mutagenicity Test Data written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1989 with Mutagenicity testing categories.

Encyclopedia Of Biopharmaceutical Statistics Four Volume Set

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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2018-09-03

Encyclopedia Of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Medical categories.

Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Drug Safety Evaluation

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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2003-09-05

Drug Safety Evaluation written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-05 with Medical categories.

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.

Supplementary Mutagenicity Tests

Supplementary Mutagenicity Tests written by United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993-11-11 with Medical categories.

Originally published in 1993, this volume describes supplementary tests used to assess risks of in vitro mutagenicity when basic safety tests were inconclusive.

Statistical Methods In Toxicology

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Author : Ludwig Hothorn
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-03-08

Statistical Methods In Toxicology written by Ludwig Hothorn and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-08 with Medical categories.

This book contains selected papers from a workshop on modern statistical methods in toxicology held during the EUROTOX '90 conference in Leipzig. The papers deal with the biostatistical evaluation of the commonly used toxicological assays, i.e. mutagenicity, long-term carcinogenicity, embryotoxicity and chronic toxicity assays. The biological background is considered in detail, and most of the related statistical approaches described. In five overview papers, the present state of the art of the related topics is given, while in several contributed papers new approaches are discussed. The most important features are: - A new view on the per-litter analysis problem in em- bryotoxicity assays. - A highly sophisticated treatment of the so-called muta-tox problem in mutagenicity assays. - A detailed discussion of the multiplicity problem based on the closed testing procedure. This volume provides readers with an overview of modern biostatistical methods for several toxicological assays and is in part intended for direct, practical use.

Biostatistics In The Study Of Toxicology

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Author :
language : en
Publisher:
Release Date : 1994

Biostatistics In The Study Of Toxicology written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Biometry categories.

Environmental Health Perspectives

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Author :
language : en
Publisher:
Release Date : 1993

Environmental Health Perspectives written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993 with Environmental health categories.

Biomaterials Medical Devices And Combination Products

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Author : Shayne Cox Gad
language : en
Publisher: CRC Press
Release Date : 2015-12-01

Biomaterials Medical Devices And Combination Products written by Shayne Cox Gad and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-12-01 with Medical categories.

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

Statistical Evaluation Of Mutagenicity Test Data

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