By Smita Gopalaswamy,Venky Gopalaswamy

the sector of blend product improvement (products born of the mixing of scientific units, biologics, and medication) is so new that, whereas literature abounds on every one half separately, there are only a few guides, together with FDA files, on hand about the specified demanding situations posed by way of this nascent yet fast-growing sector.
delivering the 1st in-depth examine this leap forward box, Combination Products comprises useful directions and a close step by step approach for the advance of those novel applied sciences. It addresses the technical, clinical, regulatory, and caliber matters that come up whilst combining medicinal drugs, biologics, and clinical units right into a unmarried product. It takes a pragmatic, effectively acceptable 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 industry effectively and in a well timed demeanour.
in particular, this article explores the method from begin to end, developing a possible layout and improvement plan entire with suitable definitions. It experiences FDA and different regulatory expectancies and covers source standards, production pitfalls, post-launch compliance necessities, and supplier 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 duties in clinical machine, biologics, and pharmaceutical industries in addition to mixture items, besides the aid of Dr. Venky Gopalaswamy, a professional in company development methodologies akin to six sigma, lean, and alter administration, to supply a finished review of the sphere and a good and powerful method of the production and implementation of blend products.

Show description

Read Online or Download Combination Products: Regulatory Challenges and Successful Product Development PDF

Best pharmacology books

Get Pharmacy Wars PDF

Pharmacy Wars via Andrea Lynne Berman

Download PDF by Daria Mochly-Rosen,Kevin Grimes: A Practical Guide to Drug Development in Academia: The SPARK

"A lot of hard-won wisdom is laid out right here in a quick yet informative method. each subject is definitely referenced, with citations from either the first literature and suitable assets from the net. " overview from Nature Chemical BiologyWritten by way of the founders of the SPARK application at Stanford college, this e-book is a pragmatic consultant designed for professors, scholars and clinicians at educational learn associations who're attracted to studying extra concerning the drug improvement method and the way to assist their discoveries turn into the unconventional medicines of the longer term.

Diane J. Burgess's Injectable Dispersed Systems: Formulation, Processing, and PDF

This authoritative consultant will function the most up-tp-date resource at the layout and production of parenteral dispersed systems-showcasing the application of dispersed structures in drug supply, drug concentrating on, and pharmaceutical engineering.

Get Standardisierte Rezepturen: Formelsammlung für Ärzte (Govi) PDF

Rezepturarzneimittel spielen vor allem in der Dermatologie, Pädiatrie und der HNO-Medizin eine beachtliche Rolle. Jedoch führt nicht jede Kombination von Wirk- und Hilfsstoffen zu einem sicheren und wirksamen Arzneimittel. Orientierung bieten standardisierte Rezepturen, bei denen therapeutische Grundsätze und pharmazeutische Qualität aufeinander abgestimmt sind.

Extra resources for Combination Products: Regulatory Challenges and Successful Product Development

Sample text

Download PDF sample

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

by Ronald

Rated 4.11 of 5 – based on 46 votes