Overview

Shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace-offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies.

Full Product Details

Author:   Donald Monkhouse (Aprecia Pharmaceuticals Company, Langhorne, Pennsylvania, US) ,  Christopher Rhodes (Narragansett, Rhode Island, USA)
Publisher:   Taylor & Francis Inc
Imprint:   Marcel Dekker Inc
Volume:   147
Dimensions:   Width: 15.20cm , Height: 2.60cm , Length: 22.90cm
Weight:   0.680kg
ISBN:  

9780824798529

ISBN 10:   082479852
Pages:   406
Publication Date:   24 October 1997
Audience:   College/higher education ,  Professional and scholarly ,  Postgraduate, Research & Scholarly ,  Professional & Vocational
Replaced By:   9780824754624
Format:   Hardback
Publisher's Status:   Out of Print
Availability:   In Print  
Limited stock is available. It will be ordered for you and shipped pending supplier's limited stock.

Table of Contents

Reviews

This practical guideoffer[s] authoritative evaluations of the scientific & legal issues involved in the successful completion of clin trials for marketing approval by regulatory agencies. -Unlisted Drugs very comprehensive on the subject and does give a lot of how-to information. very well written and very much geared towards the US market and Food and Drug Administration requirements. covers the process of clinical development and the involvement of the clinical trials materials manager at all stages. There is an excellent chapter on contract manufacturing. -European Journal of Parenteral Sciences describes both the science and the management of product development and furnishes effective approaches for preclinical drug discovery. -BOOKNews on the Internet

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