ABSTRACT

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.

chapter 1|23 pages

Strategy

chapter 2|18 pages

The Market

chapter 3|20 pages

The Clinical Plan

chapter 4|25 pages

The Preclinical Plan

chapter 5|28 pages

Regulatory Issues

chapter 7|33 pages

Project Managing the Plan

chapter |50 pages

Case Study

Miraculo Corporation