From sterile compounding to handling controlled substances, a crucial aspect of conducting successful early phase trials is the careful preparation of both investigational and non-investigational products to be used in a clinical trial setting.
As Phase 1 clinical trials include several different design types with multiple objectives (e.g. First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), and often require consistent batches of drug product be administered to groups of research participants within a short timeframe, early phase studies present unique challenges for drug developers not typically experienced in later stages of development.
This webinar will present key considerations for successfully planning pharmacy activities in early phase trials including items such as:
- Evaluating equipment and supply needs, with an emphasis on specialized items needed for the preparation of subject doses
- Developing a pharmacy manual, which is essential for incorporating the detailed procedural steps not commonly seen in the study protocol
- Strategies for appropriate blinding across different routes of administration
- Preparing suitable placebos and ensuring blinding is maintained
- Selecting comparator or positive control drugs
- Identifying vendors for drug product sourcing that are dedicated to clinical research
- Drug product storage, monitoring, handling, transfer, and security protocols
- Obtaining controlled substances
Join this webinar to receive expert guidance from pharmacy professionals specializing in early clinical development.