Bioavailability and Bioequivalence

Topics

• When a BA/BE study is obligatory
• The fundamentals of bioavailability, bioequivalence and biowaivers
• Strategies for testing highly variable drugs and design studies for different types of formulation
• The various BA/BE protocol studies that are used
• Calculate pharmacokinetic parameters on various types of studies and formulations
• Bioanalytical method validation and requirements in the US and EU
• Interpret biowaiver regulations in the US and EU and meet compliance
• The regulations in the EU, US, Russia, Brazil, China and Japan for bioequivalence studies to gain a global perspective and maintain compliance
• Issues with metabolites, endogenous products, enantiomers, long half-lifes and narrow therapeutic index drugs
• The risk associated with submitting a biowaiver

Who should Attend

Professionals from:

• Quality Assurance
• Clinical Drug Development
• Project Management
• Regulatory Affairs
• Biostatistics
• Bioanalytics
• R&D
• IVIVC