Combination Drug Products: A Development
Road Map to Clinical Trials
Justin Lacombe, Ph.D.
Chief Scientific Officer
Julie D. Suman, RPh,
Scientific Affairs, Next Breath
As a combination drug product development project moves from the laboratory into production to generate supplies for clinical research, it is necessary to involve multiple functions including manufacturing, engineering, and analytical support to make and release these materials. This is especially true for inhalation and nasally administered powders. The complexity of transferring a drug product is increased when the product involves a drug-device combination.
In this webinar, the speakers will examine what you need to know about your product to effectively support these transitions, including understanding the target product profile, critical quality attributes, product and device variability, analytical testing, regulatory requirements, and the interaction of testing and manufacturing parameters. Similarly, the receipt, inspection, and assembly of the device components will be discussed within the context of their impact on device efficiency, and thereby their effect on product delivery and performance. Aspects of device evaluation will also be discussed in terms of performance and more routine testing such as assays.
Watch the webinar to learn about critical steps to transfer the development process, sponsor and service provider responsibilities, and an efficient framework to collaborate with partners will be presented to help minimize delays and accelerate timelines on your pathway to the clinic.
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