Accelerating CNS Drug Development

Accelerating CNS Drug Development

Hardcover

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Overview

There has been a remarkable increase in the number of available drugs for disorders of the CNS in recent years and there are many more novel compounds in the pipeline. But most of these compounds will be in development for many years. Although it is vital that trials are thorough, there are ways of accelerating development so that these vital drugs are available sooner. Based on evidence from real examples, this book examines options on the design of trials, and questions the need for prolonged testing in some areas. It is, therefore, an essential text for all those involved in the development of CNS drugs.

Product Details

ISBN-13: 9780471981282
Publisher: Wiley
Publication date: 10/22/1999
Pages: 194
Product dimensions: 6.22(w) x 9.29(h) x 0.75(d)

Table of Contents

Antecedents to Clinical Exposure.
Surrogate Endpoints.
Design Options.
The Bridging Study: Optimizing the Dose for Phase II/III.
Regulatory Issues.
Concluding Remarks.
Index.

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