PHARMACOLOGY CONSULTING SERVICES for Contraception Research

The Contraception Research Branch (CRB) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has the goal to promote contraceptive research and development to prevent or reduce unintended pregnancies.

This contract is to support the ad hoc consulting and opinions for pharmacology related services for the Contraception Research Branch (CRB) of NICHD, including but not limited to:

• Liaise between various research facilities and NICHD staff to ensure planned studies achieve necessary pharmacokinetic requirements to meet NICHD CRB objectives.

• Evaluate existing non-clinical data and advise on optimal pharmacokinetic sampling strategies (including time points and matrices).

• Provide review of contractor bioanalytical methodology to ensure accuracy and precision in accordance with FDA guidance.

• Perform preclinical non-compartmental pharmacokinetic data analysis generating basic pharmacokinetic parameters based on drug levels over time in plasma or other matrices.

• Prepare standalone pharmacokinetic reports and/or pharmacokinetic supplements for inclusion in existing study reports.