ABSTRACT

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou

chapter 4|31 pages

Environmental Risk Assessment

chapter 5|11 pages

Quality Overall Summary

chapter 6|18 pages

The Nonclinical Overview and Summary

chapter 11|15 pages

Control of Drug Substance

chapter 16|14 pages

Drug Product—Excipients

chapter 21|23 pages

Nonclinical Testing Strategy

chapter 22|13 pages

Pharmacology

chapter 24|25 pages

Single and Repeat Dose Toxicity

chapter 25|17 pages

Genotoxicity

chapter 26|10 pages

Carcinogenicity

chapter 29|23 pages

Immunotoxicology

chapter 36|14 pages

Postmarketing Evaluation

chapter 38|11 pages

Pregnancy and Children

chapter 40|27 pages

Good Clinical Practice