Working Group

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Pre-Clinical and Clinical Sciences Workgroup (PCS-WG) Q4-2015 Update

The PCS-WG is focused on the evidence-based evaluation of translational tools to support effective decision-making and advance new agents from the pre-clinical to clinical development space.  These tools represent innovative approaches to address pre-clinical issues, including pre-clinical in vitro and in vivo efficacy, pre-clinical drug safety, and toxicology, pre-clinical PK/PD analyses involving the use of appropriate biomarkers, pre-clinical drug metabolism, drug interaction potential and pharmaceutical profiles. These tools may be submitted to regulatory authorities for regulatory review and/or qualification as appropriate. The PCS-WG also addresses other issues such as pharmaceutics and clinical PK/PD analyses of concentration vs. pharmacologic response data from clinical studies.

4Q, 2015 Progress:

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