The Role of Biopharmaceutics in Early Drug Development6 October 2021
The Role of Biopharmaceutics in Early Drug Development
Nominated candidates entering clinical development often have sub-optimal physicochemical, biopharmaceutical, or DMPK properties for oral delivery. Development teams are challenged with how to understand the properties of new drug candidates, how to design the appropriate formulation strategy, and how to move quickly and successfully into early-phase clinical trials. Along the way, it is important to identify developability risks and take steps to mitigate these factors, balanced carefully against time and cost investments.
This webinar discusses effective strategies being used by biotech and pharmaceutical companies to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline; and explores alternative approaches for accelerating your early development plan.
Learn about case studies relating to:
• Poor solubility molecules
• Drugs with short half-lives
• Preclinical to clinical translation.
Key Learning Objectives:
• The importance of salt and polymorph screening and prototype selection for pre-clinical assessment
• BCS or DCS assignment and developing a formulation strategy for poorly soluble molecules
• The role of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) for rational formulation design
• Teasing apart the drivers of poor bioavailability - In-vitro testing / in-silico techniques / in-vivo preclinical studies / clinical assessment
• Choosing the appropriate dosage form for first-in-human trials
• Formulation optimization using adaptive clinical programs