Download or read book Statistical Evaluation of Mutagenicity Test Data written by David J. Kirkland and published by Cambridge University Press. This book was released on 2008-01-03 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Statistical Evaluation of Mutagenicity Test Data written by and published by . This book was released on 1989 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Statistical Methods in Toxicology written by Ludwig Hothorn and published by Springer Science & Business Media. This book was released on 2013-03-08 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book OECD Guidelines for the Testing of Chemicals Section 4 Test No 471 Bacterial Reverse Mutation Test written by OECD and published by OECD Publishing. This book was released on 1997-07-21 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: The bacterial reverse mutation test uses amino-acid requiring at least five strains of Salmonella typhimurium and Escherichia coli to detect point mutations by base substitutions or frameshifts. The principle of this bacterial reverse mutation test ...
Download or read book Design and Analysis of Animal Studies in Pharmaceutical Development written by Shein-Chung Chow and published by CRC Press. This book was released on 1998-01-15 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examples. "
Download or read book Encyclopedia of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 4031 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Encyclopedia of Quantitative Risk Analysis and Assessment written by and published by John Wiley & Sons. This book was released on 2008-09-02 with total page 2163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leading the way in this field, the Encyclopedia of Quantitative Risk Analysis and Assessment is the first publication to offer a modern, comprehensive and in-depth resource to the huge variety of disciplines involved. A truly international work, its coverage ranges across risk issues pertinent to life scientists, engineers, policy makers, healthcare professionals, the finance industry, the military and practising statisticians. Drawing on the expertise of world-renowned authors and editors in this field this title provides up-to-date material on drug safety, investment theory, public policy applications, transportation safety, public perception of risk, epidemiological risk, national defence and security, critical infrastructure, and program management. This major publication is easily accessible for all those involved in the field of risk assessment and analysis. For ease-of-use it is available in print and online.
Download or read book Statistical Decision Theory and Related Topics V written by Shanti S. Gupta and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Fifth Purdue International Symposium on Statistical Decision The was held at Purdue University during the period of ory and Related Topics June 14-19,1992. The symposium brought together many prominent leaders and younger researchers in statistical decision theory and related areas. The format of the Fifth Symposium was different from the previous symposia in that in addition to the 54 invited papers, there were 81 papers presented in contributed paper sessions. Of the 54 invited papers presented at the sym posium, 42 are collected in this volume. The papers are grouped into a total of six parts: Part 1 - Retrospective on Wald's Decision Theory and Sequential Analysis; Part 2 - Asymptotics and Nonparametrics; Part 3 - Bayesian Analysis; Part 4 - Decision Theory and Selection Procedures; Part 5 - Probability and Probabilistic Structures; and Part 6 - Sequential, Adaptive, and Filtering Problems. While many of the papers in the volume give the latest theoretical developments in these areas, a large number are either applied or creative review papers.
Download or read book Environmental Health Perspectives written by and published by . This book was released on 1996 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Statistics in Toxicology written by Byron J. T. Morgan and published by Oxford University Press. This book was released on 1996 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-12-01 with total page 1753 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Basic Mutagenicity Tests written by David J. Kirkland and published by Cambridge University Press. This book was released on 1990-08-31 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: A summary of the essential texts that must be performed on all new compounds before they can be registered for use in the UK.
Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-15 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.
Download or read book Supplementary Mutagenicity Tests written by United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing and published by Cambridge University Press. This book was released on 1993-11-11 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 1993, this volume describes supplementary tests used to assess risks of in vitro mutagenicity when basic safety tests were inconclusive.
Download or read book Biostatistics in the Study of Toxicology written by and published by . This book was released on 1994 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Genetic Toxicology and Cancer Risk Assessment written by Wai Nang Choy and published by CRC Press. This book was released on 2001-08-31 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents state-of-the-art regulatory cancer risk assessment models including a biologically based model for two-hit carcinogenesis and cell proliferation! This book comprehensively reviews the various roles of genetic toxicology in human cancer risk assessment conducted by United States and worldwide regulatory agencies-discussing hazard identification, dose-response relationships, exposure assessment, and current practices of risk characterization. Examines predictive values of mutagenicity tests, mechanisms of carcinogenesis, and conventional genotoxicity tests required by the International Conference on Harmonization and the Organization for Economic Cooperation and Development/Environmental Protection Agency guidelines! Comprised of contributions from prominent experts and risk assessors and including nearly 1200 references to facilitate further study, Genetic Toxicology and Cancer Risk Assessment reviews contemporary human cancer genetics as related to the mutagenic nature of carcinogenesis calculates acceptable exposure levels based on a carcinogenic threshold dose for nongenotoxic carcinogens reveals the rationale and methodology of quantitative estimation of human cancer risks using mathematical models discusses the threshold concept of carcinogenesis demonstrates how bacterial mutagenicity assays are the most reliable for predicting rodent carcinogens considers structural activity relationship (SAR) analysis of chemical carcinogenicity describes the emergence of the mouse lymphoma microwell and in vitro micronucleus assays illustrates the use of genetic biomarkers for dosimetry analysis and more! Linking human cancer genetics, mutagenicity assays, mechanisms of carcinogenesis, carcinogenic thresholds, molecular epidemiology, mathematical modeling, and quantitative cancer risk analysis, Genetic Toxicology and Cancer Risk Assessment is a must-have reference for toxicologists; oncologists; geneticists; biostatisticians; reproductive, developmental, cell, and molecular biologists; endocrinologists; biochemists; and upper-level undergraduate, graduate, and medical school students in these disciplines.
Download or read book OECD Guidelines for the Testing of Chemicals Section 4 Test No 475 Mammalian Bone Marrow Chromosomal Aberration Test written by OECD and published by OECD Publishing. This book was released on 2016-07-29 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt: The mammalian in vivo chromosome aberration test is used for the detection of structural chromosome aberrations induced by test compounds in bone marrow cells of animals, usually rodents (rats, mice and Chinese hamsters).
