Pharmaceutical Toxicology in Practice :A Guide to Non-clinical Development

Publication subTitle :A Guide to Non-clinical Development

Author: Alberto Lodola  

Publisher: John Wiley & Sons Inc‎

Publication year: 2011

E-ISBN: 9780470909904

P-ISBN(Hardback):  9780470371374

Subject: R9 Pharmacy

Language: ENG

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Description

This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional” toxicology in the risk assessment and risk management of pharmaceuticals.

Chapter

CONTENTS

pp.:  7 – 9

CONTRIBUTORS

pp.:  9 – 11

1 INTRODUCTION

pp.:  11 – 19

2 THE REGULATORY ENVIRONMENT

pp.:  19 – 29

3 TOXICOLOGICAL DEVELOPMENT: ROLES AND RESPONSIBILITIES

pp.:  29 – 41

4 CONTRACT RESEARCH ORGANIZATIONS

pp.:  41 – 61

5 SAFETY PHARMACOLOGY

pp.:  61 – 93

6 FORMULATIONS, IMPURITIES, AND TOXICOKINETICS

pp.:  93 – 119

7 GENERAL TOXICOLOGY

pp.:  119 – 149

8 GENETIC TOXICOLOGY

pp.:  149 – 175

9 DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

pp.:  175 – 209

10 DATA ANALYSIS, REPORT WRITING, AND REGULATORY DOCUMENTATION

pp.:  209 – 239

11 RISK MANAGEMENT

pp.:  239 – 265

INDEX

pp.:  265 – 268

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