Moving from drug discovery to drug development requires a particular skillset usually not yet honed by start-ups. This phase of the development process is highly regulated and, critically, inexperienced start-ups often underestimate the duration and cost of delivering the dosage form into the clinic while meeting regulations.
This presentation will address the following:
* aspects of the Chemistry, Manufacturing and Control (CMC) portion of the drug development process
* bioavailability and the Biopharmaceutics Classification System (BCS)
* objectives of formulation
* cost-effective strategies to reach key milestones