Biopharmaceutics, Bioavailability & Bioequivalence
> Guide formulation development strategy for new and generic drug products
> Develop bioequivalence, pharmacokinetic and clinical research study protocols and strategies for reducing bioequivalence test failures
> Explore the relationship between in vitro drug dissolution/release and in vivo drug absorption profiles for potential in vivo drug delivery, including IVIVC and prediction of extended release formulation requirements

Pharmacokinetics & Pharmacodynamics
> Provide strategic thinking and oversight for preclinical and clinical pharmacokinetic studies
> Evaluate pharmacokinetic, statistical, bioanalytical and clinical data
> Review pharmacokinetic and pharmacodynamic literature for ANDA, NDA505(b)(2) and NDA submission

Project & CRO Management

> Management of Contract Research Organizations (CRO)
> Coordinate the selection of CRO
> Review study protocols and auxiliary documentation
> Audit and monitor CROs to ensure compliance with current GCPs/GLPs and cGMPs
> Review study reports and maintain budgets and timelines

Regulatory Science & Legal Issues
> Plan, budget and execute bioavailability, bioequivalence and pharmacokinetic studies for NDA and ANDA submissions
> Interact with FDA, USP, and other regulatory agencies
> Reply to citizen petitions, draft FDA guidances, etc., that impact drug product development and approval
> Provide expert legal testimony