Generic Drug Product Development. Bioequivalence. International Regulatory Requirements

Generic Drug Product Development: Bioequivalence - International Regulatory Requirements discusses worldwide legislative and regulatory requirements for the registration of generic and/or multi-source drug products. An essential text for all professional involved in the regulation, development, and manufacture of brand-name or generic drugs, this guide provides expert advice on how to develop and market superior products while also successfully adhering to national and international laws.

Key topics include:

• how to choose the most appropriate reference drug product for generic and multi-source drugs
• the similarities and differences between US, European, and Asian legislative and regulatory requirements
• the importance of matching the quality and therapeutic equivalence of generic drugs manufactured domestically or imported to the brand product alternative