ACCELERATING CNS DRUG DEVELOPMENT - CUTLER, NEAL R.

ACCELERATING CNS DRUG DEVELOPMENT

NEAL R. CUTLER

Yayınevi: Wiley

ISBN: 9780471981282

Yazar : NEIL M. KURTZ MICHAEL F. MURPHY JOHN J. SRAMEK ANGELICO CARTA

Ciltli | İngilizce | 194 Sayfa |

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.

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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