Staying the course: progressing drug development during the COVID-19 pandemic through bioequivalence studies
With the ongoing COVID-19 pandemic extensively impacting clinical trials irrespective of indication, learn how bioequivalence studies (BCS) can be a suitable stopgap measure in the interim.
The objective of the BCS is to predict in vivo performance of drug products from in vitro measurements of dissolution, solubility and permeability in order to simplify and speed up drug development. Although many BCS class 1 (high solubility and high permeability) biowaiver applications have been submitted to regulators, there is dearth of applications being filed for BCS class 3 compounds (high solubility, low permeability). To facilitate the research community, an innovative in vitro dissolution absorption system (IDAS) has been developed to study generic compounds and new chemical entities.
What will you learn?
- Introduction to the Biopharmaceutics Classification System (BCS)
- Approach and details for studies Absorption System supports
- My compound is a substrate of P-gp, will it qualify as BCS class I?
- Introduction to IDAS
- Application of IDAS
Who may this interest?
- Medicinal chemists
- Pharmaceutical scientists
- Formulation chemists
Speaker
Rao Mukkavilli
Associate Director
Absorption Systems (GA, USA)
Rao Mukkavilli is a drug discovery and development scientist with 15 years of experience in the pharmaceutical industry. He has a PhD in drug metabolism and pharmacokinetics with 23 peer reviewed publications and two patents to his credit. During his tenure, Rao supervised and mentored in vitro ADME, pharmacokinetics (PK), toxicokinetic, clinical pharmacology and bioanalytical mass spectrometry groups. Rao also acted as a central conduit in collaborating with project teams for lead selection and optimization across various therapeutic areas.
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