Introduction to Bioequivalence and Therapeutic Equivalence 2013

Topics

• Relationships among bioequivalence, pharmaceutical equivalence and therapeutic equivalence
• FDA requirements for a successful ANDA by demonstrating bioequivalence for drug products
• Equivalency considerations for critical dose and modified release pharmaceutical products
• FDA Orange Book coding of equivalence

Who should Attend

Personnel in the biotechnology, pharmaceutical and biologics industries with responsibility for:

• Marketing
• Regulatory affairs
• Product development
• Clinical development
• Risk Management
• Quality Assurance
• Clinical Research