Title: "Testing formulations for small-molecule drug candidates suitable for early pharmacokinetic assessments."POP: 06/16/2017 - 06/15/2021

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

Investigators

Abstract

The purpose of this Task Order is to identify suitable formulations for administration of potential drug candidates to mice for early pharmacokinetic studies. Chemical structures, MW, and other available properties of test agents will be provided and should be used to provide guidance on formulation approaches (e.g., pH-adjustment, co-solvents). Route and dose level (mg/kg) targets will be provided. Compounds may be assigned individually or in batches. Test formulations for each compound will be selected from the lists below or suggested by the COR. Solubility assessments will follow laboratory SOPs. Visual solubilities in the trial formulations will be assessed and a chromatographic method (HPLC-UV, LC-MS) will be used to verify the nominal concentration present in the final proposed formulation. It is not necessary to test each of the potential formulations once a suitable choice is identified. Delivery of a final comprehensive summary spreadsheet with solubility data for all compounds evaluated under this Task Order is required. This will allow NCI management to conduct a comprehensive review across all compounds submitted.