BIOLOGICAL TESTING FACILITY - CLINICAL DEVELOPMENT AND FORMULATION OPTIMIZATION OF NEW PRODUCTS OR DEVICES FOR CONTRACEPTIVE METHODS

Sri International, Menlo Park CA

Investigators

Abstract

The objective of this task is to support preclinical and clinical formulation studies and GMP batch preparation of novel steroidal compounds or novel devices that can be evaluated in clinical trials pursuant to contraception studies in men or women. Appropriately formulated batches of drugs or devices are required for both clinical trials and for toxicology studies that are needed to demonstrate safety and efficacy of the products. Products have different formulation requirements and different pharmacodynamic properties when delivered orally, transdermally, vaginally, intrauterine or as an injectable agent. Thus, formulation studies need to be conducted to optimize the activity for the selected route of delivery. Multiple dosage forms of agents as well as placebos may be needed to be able to determine optimal efficacy in animals and human subjects. Studies may include development and validation of analytical methods associated with preparation of a clinical batch of product. For all clinical batches, manufacturing and quality control testing must be done under GMP (Good Manufacturing Practices) and preparation of appropriate regulatory documents must accompany any clinical batch that is released. Stability studies that support the clinical trials will be conducted for each clinical batch as is required for IND purposes. Drugs or devices must be stored under appropriate condition and shipped to designated clinical studies as directed by NICHD.