Changes to ICH guideline M3: new and revised guidance on nonclinical safety studies to support human clinical trials and marketing authorization

Clin Pharmacol Ther. 2011 Feb;89(2):295-9. doi: 10.1038/clpt.2010.273. Epub 2010 Dec 22.

Authors

B J Ledwith¹, J J DeGeorge

Affiliation

¹ Department of Safety Assessment & Laboratory Animal Resources, Merck Research Laboratories, West Point, Pennsylvania, USA.

PMID: 21178992
DOI: 10.1038/clpt.2010.273

No abstract available

MeSH terms

Clinical Trials as Topic / standards*
Congresses as Topic / standards*
Drug Combinations
Drug Discovery
Guidelines as Topic / standards*
Humans
International Agencies
International Cooperation*
Marketing of Health Services / standards*
Toxicity Tests / standards
Translational Research, Biomedical

Substances

Drug Combinations