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Changes to ICH Guideline M3: New and Revised Guidance on Nonclinical Safety Studies to Support Human Clinical Trials and Marketing Authorization
Author(s) -
Ledwith BJ,
DeGeorge JJ
Publication year - 2011
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2010.273
Subject(s) - guideline , authorization , marketing authorization , clinical trial , clinical pharmacology , medicine , human use , clinical practice , medical physics , pharmacology , family medicine , pathology , computer science , bioinformatics , microbiology and biotechnology , computer security , biology
The International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guideline M3 underwent substantial revision in 2009. Highlights of the changes include new sections on exploratory clinical studies, combination products, and various types of specific toxicity tests performed on a case‐by‐case basis. In addition, the revised guidance contains additional details and changes pertaining to aspects of the previous recommendations for nonclinical testing. This article describes the major changes and explains how they facilitate drug development and translate into clinical practice. Clinical Pharmacology & Therapeutics (2011) 89 2, 295–299. doi: 10.1038/clpt.2010.273