COMBINATION DRUG PRODUCTS: WHAT LIES BENEATH —
RISK ANALYSIS FOR PRODUCT DEVELOPMENT
Justin Lacombe, Ph.D.
Chief Scientific Officer
Julie D. Suman, RPh,
Scientific Affairs, Next Breath
A robust approach for combination drug product development requires an understanding of the drug product characteristics, the effects of processing and device design, and how they impact product performance. Risk management connects the dots and interactions of these critical factors.
In this webinar, the speakers will dive into the critical components of Quality by Design principles, draw parallels with device design controls, discuss differences in experimentation from development studies to quality control, and review FDA requirements that include an implicit risk analysis.
Watch the webinar to understand more about drug product characteristics, effects of processing and device design, and how risk management can help minimize delays and accelerate timelines on your pathway to the clinic.
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