Download e-book for kindle: Combination Products: Regulatory Challenges and Successful by Smita Gopalaswamy,Venky Gopalaswamy

By Smita Gopalaswamy,Venky Gopalaswamy

the sphere of mixture product improvement (products born of the mixing of scientific units, biologics, and medicine) 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 about the certain demanding situations posed via this nascent yet fast-growing quarter.
offering the 1st in-depth examine this step forward box, Combination Products comprises sensible directions and an in depth step by step technique for the advance of those novel applied sciences. It addresses the technical, clinical, regulatory, and caliber matters that come up while combining medications, biologics, and scientific units right into a unmarried product. It takes a realistic, simply 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.
in particular, this article explores the method from begin to end, constructing a achievable layout and improvement plan entire with suitable definitions. It reports FDA and different regulatory expectancies and covers source specifications, production pitfalls, post-launch compliance standards, 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 obligations in clinical gadget, biologics, and pharmaceutical industries in addition to mixture items, besides the help of Dr. Venky Gopalaswamy, a professional in company development methodologies resembling six sigma, lean, and alter administration, to supply a entire overview of the sphere and a good and powerful method of the production and implementation of blend products.

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


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