Bioavailability / Bioequivalence, Dissolution and Biowaivers 2014

Topics

• Key similarities and differences between the EMA and FDA Bioanalytical Method Validation guidances
• Updates on the new EMA Modified Release Guidance read more
• Case study on BE studies for fixed dose combination products
• The advantages and complexities of the EMA Bioequivalence Concept Paper
• 4 new dissolution testing case studies from GSK, NextPharma, Eli Lilly and Bayer, including
• Strategic advice and practical insight on highly variable drugs
• Industry use and experiences on bio-relevant dissolution testing

Who should Attend

Heads, Directors, scientists, managers and specialists from:

• Analytical development
• Pre-clinical & clinical development
• Quality control
• Research and development
• Pharmacokinetics
• Clinical pharmacology
• Medical Affairs
• Regulatory affairs