Upcoming webinar

Advancing the CMC Development of Oncology Medicines

The Role of Biopharmaceutics in Early Drug Development

Webinar - overcoming challenges for small molecules

Nominated candidates entering clinical development often have sub-optimal physicochemical, biopharmaceutic 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.

Case studies:

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

Watch now

More resources

On demand Webinars

Ask us a question

We use cookies to help us to improve our site and enables us to the best possible service and customer experience. By clicking accept you are agreeing to let us share your data with select third parties for analytics and marketing purposes.