ABSTRACT
Combination products are designed to offer greater benefits than drugs or devices acting alone. Their development and manufacture require an understanding of each of the combination product constituent parts and their interactions, impacting the safety and efficacy of the combination product as a whole. This chapter focuses on practices for successful combination product development, applying a risk-based, systems-approach. Aspects reviewed include: (i) keys to development success: language; integrated processes; cultural and organizational considerations; and supplier collaboration; (ii) the development process , covering key regulations, guidance and standards; and (iii) the development strategy, including constituent part considerations, platform technology approaches, Essential Performance Requirements, integration of Quality by Design and Design Controls, human factors, risk management, and manufacturing considerations.
