Nonclinical Studies to Support Clinical Trials
Nonclinical studies to support FIH trials • ICH M3(R2): ICH Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (2010) – ICH M3(R2) Questions and Answers(R2) (2013) – Nonclinical studies to support FIH trials with small molecules ................
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