Smita Gopalaswamy,Venky Gopalaswamy's Combination Products: Regulatory Challenges and Successful PDF

By Smita Gopalaswamy,Venky Gopalaswamy

ISBN-10: 1420064460

ISBN-13: 9781420064469

the sector of mixture product improvement (products born of the combination of scientific units, biologics, and medication) is so new that, whereas literature abounds on every one half separately, there are only a few courses, together with FDA files, to be had in regards to the detailed demanding situations posed through this nascent yet fast-growing region.
delivering the 1st in-depth examine this leap forward box, Combination Products comprises useful instructions and an in depth step by step technique for the improvement of those novel applied sciences. It addresses the technical, clinical, regulatory, and caliber concerns that come up whilst combining medications, biologics, and clinical units right into a unmarried product. It takes a pragmatic, conveniently appropriate method of discussing the demanding situations, victories, and pitfalls linked to merging applied sciences and platforms and the way to enforce those items into the marketplace effectively and in a well timed demeanour.
particularly, this article explores the method from begin to end, constructing a conceivable layout and improvement plan whole with proper definitions. It reports FDA and different regulatory expectancies and covers source requisites, production pitfalls, post-launch compliance necessities, and business enterprise audits and demanding situations.
Drawing at the event and services of 2 leaders of their respective fields, Combination items boasts the credentials of Dr. Smita Gopalaswamy, a 20 12 months veteran of technical consulting tasks in scientific equipment, biologics, and pharmaceutical industries in addition to mixture items, in addition to the aid of Dr. Venky Gopalaswamy, a professional in enterprise development methodologies reminiscent of six sigma, lean, and alter administration, to supply a accomplished overview of the sector and an effective and powerful method of the production and implementation of mix products.

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Combination Products: Regulatory Challenges and Successful Product Development by Smita Gopalaswamy,Venky Gopalaswamy


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