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Challenges of Drug/Devices Pharmaceutical Products

  • Duu-Gong WuEmail author
Chapter
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)

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.

Keywords

Combination Product Marketing Approval Stability Program Drug Component Device Component 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgment

•Steve Koepke, Ph.D. SRK Consulting

•Stuart Portnoy, M.D. PharmaNet Inc.

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.PharmaNet, Inc.PrincetonUSA

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