Safety Pharmacology Studies For Human Pharmaceuticals
This guideline was developed to help protect clinical trial participants and patients
receiving marketed products from potential adverse effects of pharmaceuticals, while
avoiding unnecessary use of...
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Safety Pharmacology Studies For Human Pharmaceuticals
This guideline was developed to help protect clinical trial participants and patients
receiving marketed products from potential adverse effects of pharmaceuticals, while
avoiding unnecessary use of animals and other resources.
This guideline provides a definition, general principles and recommendations for safety
pharmacology studies.
Pharmacology studies have been performed worldwide for many years as part of the
non-clinical evaluation of pharmaceuticals for human use. There have been, however,
no internationally accepted definitions, objectives or recommendations on the design and
conduct of safety pharmacology studies.
The term “safety pharmacology studies” first appeared in the ICH topics, “Timing of
Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for
Pharmaceuticals (M3)” and “Preclinical Safety Evaluation of Biotechnology-Derived
Pharmaceuticals (S6)” as studies that should be conducted to support use of
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