Bioavailability and Bioequivalence is a conference that covers topics such as:
- 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
Bioavailability and Bioequivalence brings together professionals from:
- Quality Assurance
- Clinical Drug Development
- Project Management
- Regulatory Affairs
- Biostatistics
- Bioanalytics
- R&D
- IVIVC