Safety Pharmacology Methodology

  • ICH Harmonised Tripartite Guideline (ICH M3 (R2): Guidance on non-clinical Safety Studies for the
    conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
  • ICH Harmonised Tripartite Guideline (ICH S6; R1): Preclinical safety evaluation of biotechnology-
    derived pharmaceuticals. Jun 2011
  • ICH Harmonised Tripartite Guideline (ICH S7A): Safety pharmacology studies for human
    pharmaceuticals. Nov 2000
  • ICH Harmonised Tripartite Guideline (ICH S7B): The non-clinical evaluation of the potential for
    delayed ventricular repolarization (qt interval prolongation) by human pharmaceuticals
  • ICH Harmonised Tripartite Guideline (ICH S9): Nonclinical evaluation for anticancer pharmaceuticals.
    Oct 2009
  • FDA Guidance on Exploratory IND studies. Jan 2006
safety pharmacology methodology
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