Combination Products: Regulatory Challenges and Successful Product Development
Author:   Smita Gopalaswamy ,  Venky Gopalaswamy
Publisher:   Taylor & Francis Inc
ISBN:  

9781420064469


Pages:   264
Publication Date:   22 April 2008
Format:   Hardback
Availability:   In Print   Availability explained
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Combination Products: Regulatory Challenges and Successful Product Development


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Full Product Details

Author:   Smita Gopalaswamy ,  Venky Gopalaswamy
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Dimensions:   Width: 15.60cm , Height: 2.20cm , Length: 23.40cm
Weight:   0.544kg
ISBN:  

9781420064469


ISBN 10:   1420064460
Pages:   264
Publication Date:   22 April 2008
Audience:   Professional and scholarly ,  Professional and scholarly ,  Professional & Vocational ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

Introduction. Overview and Definitions of Combination Products. Ensuring Successful Development. Overview of FDA and other Regulatory Agency Expectations. Resource Requirements. Manufacturing of Combination Products. Challenges and Pitfalls to Avoid with Combination Products. Post Launch Compliance Requirements. Agency Audits and Challenges. Conclusions.  

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Author Information

Smita Gopalaswamy, Venky Gopalaswamy

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NOV RG 20252

 

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