Topics
- Prediction of drug substance pharmacokinetics
- Development of dissolution tests and their biomimetic value
- Design of a biomimetic dissolution test
- Consideration of pKa and sites of adsorption
- Biostudy results vs. statistical requirements
- Value of iViV correlations – regulatory viewpoint
- Relationship between formulation and bioavailability
- Use of dissolution studies to obtain biowaivers
Who should Attend
Dissolution testing specialists Pharmacokineticists, Regulatory affairs professionals, BA/BE managers Formulation managers, IVIVC specialists and Solid dosage formulators.