Statistical Evaluation of Mutagenicity Test Data

Statistical Evaluation of Mutagenicity Test Data
Author: David J. Kirkland
Publisher: Cambridge University Press
Total Pages: 316
Release: 2008-01-03
Genre: Medical
ISBN: 9780521048149

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 Methods in Toxicology

Statistical Methods in Toxicology
Author: Ludwig Hothorn
Publisher: Springer Science & Business Media
Total Pages: 158
Release: 2013-03-08
Genre: Medical
ISBN: 364248736X

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.

Basic Mutagenicity Tests

Basic Mutagenicity Tests
Author: David J. Kirkland
Publisher: Cambridge University Press
Total Pages: 164
Release: 1990-08-31
Genre: Medical
ISBN: 9780521393478

A summary of the essential texts that must be performed on all new compounds before they can be registered for use in the UK.

Handbook of Mutagenicity Test Procedures

Handbook of Mutagenicity Test Procedures
Author: B.J. Kilbey
Publisher: Elsevier
Total Pages: 876
Release: 2012-12-02
Genre: Medical
ISBN: 0444600981

The compilation of this book was prompted by the necessity of a bench volume which could provide the necessary background information on materials, experimental design, pitfalls and dificulties, in order to perform a particular test in an acceptable way with a minimal need for additional expert help. This Second Edition updates this information, providing: - a comprehensive bench guide - methods known to be reliable - a broad spectrum of approaches - tips to avoid pitfalls when using unfamiliar techniques - data from population records - safety aspects of mutagens and carcinogens - basic statistical concepts for experiment design This `on the bench' methodological text provides the necessary information for most of the common assays for genetic damage in use. The book includes methods which have been sufficiently used and tested to make their use reliable, but also presents methods which are not widely used at present, but which might prove most useful in screening for mutagenic effects.

Statistics in Toxicology

Statistics in Toxicology
Author: Byron J. T. Morgan
Publisher: Oxford University Press
Total Pages: 250
Release: 1996
Genre: Mathematics
ISBN: 9780198523291

This collection of papers on aspects of statistics in toxicology is will be of interest to all medical statisticians. It offers findings from numerous leading experts from around the world including A. Whitehead and R. N. Connor (University of Reading), L. Ryan (Harvard), A. P. Grieve (Pfizer Research), K.J. Risko (Northern Telecom), and B.H. Margolin (University of North Carolina). This is the latest in the popular Royal Statistical Society Lecture Series, and will be essential reading for all those involved in this area.

Drug Safety Evaluation

Drug Safety Evaluation
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Total Pages: 918
Release: 2016-11-18
Genre: Medical
ISBN: 1119097401

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

Supplementary Mutagenicity Tests

Supplementary Mutagenicity Tests
Author: United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing
Publisher: Cambridge University Press
Total Pages: 179
Release: 1993-11-11
Genre: Medical
ISBN: 052145073X

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

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set
Author: Shein-Chung Chow
Publisher: CRC Press
Total Pages: 2434
Release: 2018-09-03
Genre: Medical
ISBN: 1351110268

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.