Preclinical development handbook. Toxicology / [edited by] Shayne Cox Gad.

Format:

Book

Contributor:

Gad, Shayne C., 1948-

Series:

Pharmaceutical Development Series

Pharmaceutical Development Series ; v.4

Language:

English

Subjects (All):

Drugs--Toxicology--Handbooks, manuals, etc.

Drugs.

Drugs--Toxicity testing--Handbooks, manuals, etc.

Physical Description:

1 online resource (1075 p.)

Edition:

1st ed.

Other Title:

Toxicology

Place of Publication:

Hoboken, NJ : Wiley-Interscience, c2008.

Language Note:

English

Summary:

A clear, straightforward resource to guide you through preclinical drug developmentFollowing 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, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques.Each chapter was written by one or more leading experts

Contents:

PRECLINICAL DEVELOPMENT HANDBOOK Toxicology; CONTRIBUTORS; CONTENTS; Preface; 1 Preclinical Drug Development Planning; 2 Use of Project Teams in Preclinical Development; 3 Relationship between Animal Models and Clinical Research: Using Mucositis as a Practical Example; 4 Bacterial Mutation Assay; 5 In Vitro Mammalian Cell Mutation Assays; 6 In Vitro Mammalian Cytogenetic Tests; 7 In Vivo Genotoxicity Assays; 8 Repeat Dose Toxicity Studies; 9 Irritation and Local Tissue Tolerance Studies in Pharmacetical Safety Assessment; 10 Safety Assessment Studies: Immunotoxicity

11 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects12 Reproductive and Developmental Toxicology; 13 Carcinogenicity Studies; 14 Toxicokinetics: An Integral Component of Preclinical Toxicity Studies; 15 In Vitro Toxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data; 16 Toxicologic Pathology; 17 Secondary Pharmacodynamic Studies and In Vitro Pharmacological Profiling; 18 Current Practices in Safety Pharmacology; 19 Safety Assessment of Biotechnology-Derived Therapeutics; 20 Preclinical Development of Protein Pharmaceuticals: An Overview

21 The Pharmacogenomics of Personalized Medicine22 Genomics; 23 Proteomics; 24 Toxicogenomics in Preclinical Development; 25 Toxicoproteomics: Preclinical Studies; 26 Regulatory Considerations; 27 Regulatory Issues in Preclinical Safety Studies (U.S. FDA); 28 Selection and Utilization of CROs for Safety Assessment; 29 Auditing and Inspecting Preclinical Research and Compliance with Good Laboratory Practice (GLP); 30 Drug Impurities and Degradants and Their Safety Qualification; 31 Bridging Studies in Preclinical Pharmaceutical Safety Assessment; Index

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on metadata supplied by the publisher and other sources.

ISBN:

1-281-23742-6

9786611237424

0-470-24905-6

0-470-24904-8

OCLC:

476138565