Summary
This unique 2-day online training course provides practical insights into pharmacokinetics and bioequivalence studies as related to solid dosage formulations.
Learning Objectives
- 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
Key Topics
- 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
Who should attend?
BA/BE managers, R&D managers, Pharmacokinetics scientists, IVIVC specialists, Formulation managers, Solid dosage formulators, Regulatory affairs managers
Past participants
- Clinical Pharmacologist, Boehringer Ingelheim
- DMPK & Clinical Pharmacology Head, Basilea Pharmaceutica International
- BE Assessor, Icelandic Medicines Agency
- Director Analytical Development Drug Product, Idorsia
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 30 days
- Digital and LinkedIn certificates
Trainers
Bioequivalence and IVIVC
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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