Jean-Pierre Valentin

Beyond NAMs versus animal models: Context of use as the governing framework for integrated nonclinical strategies in drug development.

New approach methodologies (NAMs) originated in chemical hazard assessment, where two forces operate together: the scale of characterizing many substances, and a long-standing ethical and legal commitment to replacing animal testing. Drug development is weighted differently. It is a translational and decision problem a...

Integration of safety pharmacology endpoints into toxicology studies - A survey of GLP institutions in China.

Integrating safety pharmacology (SP) endpoints into repeated-dose toxicology studies enables the simultaneous assessment of organ toxicity and determination of functional safety risks within a single study, a practice endorsed by regulatory guidelines. Initiated by the Chinese Safety Pharmacology Society, this question...

Pediatric Developmental Safety Assessment and New Approach Methodologies: US FDA/Triangle CERSI Workshop Report.