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

, , Comments Off on Combination Products: Regulatory Challenges and Successful by Smita Gopalaswamy,Venky Gopalaswamy

By Smita Gopalaswamy,Venky Gopalaswamy

the sector 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 guides, together with FDA files, to be had in regards to the detailed demanding situations posed through this nascent yet fast-growing zone.
delivering the 1st in-depth examine this leap forward box, Combination Products comprises sensible guidance and a close step by step method for the advance of those novel applied sciences. It addresses the technical, medical, regulatory, and caliber concerns that come up whilst combining medications, biologics, and clinical units right into a unmarried product. It takes a pragmatic, easily 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.
particularly, this article explores the method from begin to end, setting up a viable layout and improvement plan whole with suitable definitions. It experiences FDA and different regulatory expectancies and covers source specifications, 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 clinical machine, biologics, and pharmaceutical industries in addition to mixture items, in addition to the aid of Dr. Venky Gopalaswamy, knowledgeable in company development methodologies corresponding to six sigma, lean, and alter administration, to supply a finished evaluate of the sphere and an effective and potent method of the production and implementation of mix products.

Show description

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

Similar pharmacology books

Pre-Invasive Disease: Pathogenesis and Clinical Management

This booklet is written via foreign specialists of their box and will entice scholars and pro researchers, to scientists and to clinicians. No past wisdom of the subject is needed to understand this article and but the ebook charters new territory. New views are given on how our wisdom of melanoma improvement could lead us to think again our scientific method of early detection and prevention of melanoma at a person and inhabitants point.

Advances in Behavioral Pharmacology: Volume 6: Neurobehavioral Pharmacology: Neurobehavioral Pharmacology v. 6

First released in 1987. Routledge is an imprint of Taylor & Francis, an informa company.

Medication Safety Officer's Handbook

The medicine defense officer's area is attention-grabbing, not easy, and ever-evolving. even if you are new to medicine protection or an skilled medicine safeguard Officer (MSO), this advisor can be a useful source. the medicine protection Officer's instruction manual deals professional tips in each sector of your paintings, from constructing protection structures to facing group of workers difficulties, besides pattern varieties, checklists and different task instruments.

Hospital-Based Health Technology Assessment: The Next Frontier for Health Technology Assessment

A well timed paintings describing how localized hospital-based wellbeing and fitness know-how evaluate (HB-HTA) enhances basic, ‘arms-length’ HTA enterprise efforts, and what has been the collective international impression of HB-HTA around the globe. whereas HB-HTA has received major momentum during the last few years, services within the box, and knowledge at the operation and association of HB-HTA, has been scattered.

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

Example text

Download PDF sample

Rated 4.56 of 5 – based on 37 votes