ICH guidelines: inception, revision, and implications for drug development.
Wang
Tao
T
Preclinical Safety, Novartis Pharmaceuticals Corporation, Emeryville, California 94608, USA. tao.wang@novartis.com
Jacobson-Kram
David
D
Pilaro
Anne M
AM
Lapadula
Daniel
D
Jacobs
Abigail
A
Brown
Paul
P
Lipscomb
John
J
McGuinn
William David
WD
D000818:Animals; D000970:Antineoplastic Agents / Q000494:pharmacology; D001688:Biological Products / Q000633:toxicity; D001709:Biotechnology / Q000379:methods; D015195:Drug Design; D055808:Drug Discovery; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies / Q000458:organization & administration*; D007391:International Cooperation; D009152:Mutagenicity Tests; D012098:Reproduction / Q000187:drug effects
D000970:Antineoplastic Agents; D001688:Biological Products