Faculty Advisor

Adams, David S.

Abstract

This Interactive Qualifying Project (IQP) sets forth guidelines and offers advice as to how companies can increase the success rates for the approval of their products during clinical trials with the aim of attaining and maintaining Food and Drug Administration (FDA) approval. FDA actions against non-conforming products and corporation were studied. Advice concerning validation considerations throughout the entire approval process and beyond was addressed with special attention to current Good Manufacturing Practices and software/control system validation. The societal and economic impacts of the entire regulatory affair were examined centering upon pharmaceuticals, including Zomax, EPO, Triazure, Vasotec, Serc and Pulmozyme, including the integratory effects of improved approval success rates.

Publisher

Worcester Polytechnic Institute

Date Accepted

January 1999

Project Type

Interactive Qualifying Project

Accessibility

Restricted-WPI community only

Advisor Department

Biology and Biotechnology

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