Essential CNS Drug Development (eBook, ePUB)

Redaktion: Kalali, Amir

• Format: ePub

Produktbeschreibung

Central Nervous System disorders have an enormous impact on individuals and on society as a whole. The development of better treatments is crucial and is a major focus of pharmaceutical and biotechnology companies. This book explains the complicated process of CNS drug development in a way that is engaging for any interested professional or student. Chapters cover each stage of drug development, from pre-clinical research through all phases of clinical trials, to reporting to the regulatory authorities. Other key issues covered include strategic considerations, regulatory constraints, dissemination of results and ethical considerations. The user-friendly format and style enable readers to find important information quickly and easily. Written and edited by experts from different sectors actively engaged in CNS drug development, this is a unique resource for drug developers, investigators, academics and clinicians.

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Produktdetails

• Verlag: Cambridge University Press
• Erscheinungstermin: 7. Juni 2012
• Englisch
• ISBN-13: 9781139579179
• Artikelnr.: 52916700

Inhaltsangabe

Preface; 1. History of CNS drug development Sheldon H. Preskorn; 2.
Regulatory issues Gwen L. Zornberg; 3. Pre-clinical development Alan J.
Cross and Frank D. Yocca; 4. Phase I trials: from traditional to newer
approaches Matthew Macaluso, Michael Krams and Sheldon H. Preskorn; 5.
Phase II development and the path to personalized medicine in CNS disease
Douglas E. Feltner and Kenneth R. Evans; 6. CNS drug development - Phase
III Judith Dunn, Penny Randall and Amir Kalali; 7. Statistics issues
relevant to CNS drug development Craig H. Mallinckrodt, William R. Prucka
and Geert Molenberghs; 8. Clinical trials management at company level Nuala
Murphy; 9. Clinical trials management at the site level Joseph Kwentus; 10.
Medical writing for CNS indications Ginette Nachman; 11. Dissemination of
clinical trial information: multiple audiences, multiple formats Leslie
Citrome; 12. The importance of treating cognition in schizophrenia and
other severe mental illnesses: background, strategies, and findings to date
Philip D. Harvey and Richard S. E. Keefe; 13. Leveraging disruptive
technologies to drive innovation in CNS clinical drug development Penny
Randall, Judith Dunn and Amir Kalali; Index.