Bioequivalence and IVIVC
15 – 16 March 2021, online training
This unique 2-day online training course integrates the pharmacokinetics and biostudies as related to solid dosage formulations.
Who should attend?
BA/BE managers, R&D managers, Pharmacokinetics scientists, IVIVC specialists, Formulation managers, Solid dosage formulators, Regulatory affairs managers
- How to design a bioequivalence study
- The statistical design needed to get regulatory approval
- Connecting the dissolution data to pharmacokinetics
- The predictive power of pilot studies
- The requirements for studies in fasting and fed state
- Validation and compliance issues
- What is the relationship between formulation and bioavailability?
- What to look for when auditing a biostudy house in terms of validation
- Project management of biostudies
- General Requirements for Biostudies
- Establishing the Biostudy Statistical Design
- Similarity, Comparability, and Correlation
- Predictive Power of Dissolution and Alternatives to Full BE
- Validation and Compliance Issues