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.
- FDA Guidance on Exploratory IND studies. Jan 2006
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PK/PD and Metabolism
Over the drug discovery process, ADME (Absorption, Distribution, Metabolism, and Elimination) and PK studies are deemed necessary to evaluate the bioavailability…
Inhalation toxicity studies are required to assess the exposure hazards for consumer products or manufacturing workers.
Vivotecnia offers Irwin Test as central nervous system study, which is included in our safety pharmacology services portfolio