Clinical Development: Strategic, Pre-Clinical, and Regulatory Issues

Clinical Development: Strategic, Pre-Clinical, and Regulatory Issues

by Janice Steiner, Steiner Steiner
     
 

ISBN-10: 1574910280

ISBN-13: 9781574910285

Pub. Date: 11/30/1996

Publisher: Taylor & Francis

Everyone involved in pre-clinical, clinical, formulation, development and regulatory affairs will find Clinical Development a valuable resource. The book provides expert advice on ways to reduce delays and lost market opportunities, minimize development time, better understand the process and regulatory requirements, and plan and analyze clinical development and

…  See more details below

Overview

Everyone involved in pre-clinical, clinical, formulation, development and regulatory affairs will find Clinical Development a valuable resource. The book provides expert advice on ways to reduce delays and lost market opportunities, minimize development time, better understand the process and regulatory requirements, and plan and analyze clinical development and testing programs. The author combines text, graphs, and charts to show how a company moves a product through the complex process from discovery to market. The result is a complete analysis of the drug development process in easy-to-understand language and easy-to-implement action steps.

Product Details

ISBN-13:
9781574910285
Publisher:
Taylor & Francis
Publication date:
11/30/1996
Edition description:
New Edition
Pages:
248
Product dimensions:
7.20(w) x 10.10(h) x 0.80(d)

Table of Contents

o Developing a complete strategy
•Analyzing potential markets in depth
•Preparing the clinical plan
•Understanding the pre-clinical requirements
•Incorporating regulatory plans early in the process
•Meeting Good Clinical Practice (GCP) regulations
•Managing the project plan
•Mastering the process - a detailed case study

Customer Reviews

Average Review:

Write a Review

and post it to your social network

     

Most Helpful Customer Reviews

See all customer reviews >