Abstract
Due to significant differences in regulatory approaches and requirements by different review centers within FDA, design of a stability program to support the development and approval of a drug/device combination product can present significant challenges. Having an in-depth understanding of the stability issues and regulatory requirements associated with this type of drug/device combination products is critical to avoid the costly delay of the product development and marketing approval.
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Acknowledgment
•Steve Koepke, Ph.D. SRK Consulting
•Stuart Portnoy, M.D. PharmaNet Inc.
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© 2010 American Association of Pharmaceutical Scientists
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Wu, DG. (2010). Challenges of Drug/Devices Pharmaceutical Products. In: Huynh-Ba, K. (eds) Pharmaceutical Stability Testing to Support Global Markets. Biotechnology: Pharmaceutical Aspects, vol XII. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-0889-6_11
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DOI: https://doi.org/10.1007/978-1-4419-0889-6_11
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Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4419-0888-9
Online ISBN: 978-1-4419-0889-6
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