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

by Janice Steiner

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:	9781000725025
Publisher:	CRC Press
Publication date:	11/14/2019
Sold by:	Barnes & Noble
Format:	eBook
Pages:	248
File size:	4 MB

About the Author

Janice Steiner founded Oxford Therapeutics Consulting Limited, a clinical consultancy, in 1992. Prior to establishing her own company, Dr. Steiner was Medical Director at Gensia Europe, Ltd., Director of Clinical Pharmacology at Searle Research and Development and Roche Products Ltd. Her experience includes all aspects of clinical trials including planning, executing, setting policy, and managing trials., The author of numerous publications, Dr. Steiner received a D. Phil. From Oxford University and an MBA from Middlesex Business School.

Table of Contents

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.

Editorial Reviews

Shows how to reduce delays in clinical drug testing, using detailed examples and an extended case study of a product moving from discovery to market. Explains how to develop a strategy, analyze potential products and markets, incorporate regulatory requirements early in the process, meet GCP requirements, and manage the project plan. Includes chapter summaries, and many charts and tables. For those involved in pre-clinical, clinical, formulation, development, and regulatory affairs, and for professionals in related areas of management, marketing, and manufacturing. Annotation c. by Book News, Inc., Portland, Or.

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