Bioequivalence and IVIVC

Summary

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

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