Essential CNS drug development /
Essential CNS drug development /
edited by Amir Kalali [and others].
- Cambridge : Cambridge University Press, 2012.
- 1 online resource (x, 207 pages) : digital, PDF file(s).
Title from publisher's bibliographic system (viewed on 05 Oct 2015).
History of CNS drug development / Regulatory issues / Essential CNS drug development : pre-clinical development / Phase I trials : from traditional to newer approaches / Phase II development and the path to personalized medicine in CNS disease / CNS drug development : Phase III / Statistics issues relevant to CNS drug development / Clinical trials management at company level / Clinical trials management at the site level / Medical writing for CNS indications / Dissemination of clinical trial information : multiple audiences, multiple formats / The importance of treating cognition in schizophrenia and other severe mental illnesses : background, strategies, and findings to date / Leveraging disruptive technologies to drive innovation in CNS clinical drug development / Sheldon H. Preskorn -- Gwen L. Zornberg -- Alan J. Cross and Frank D. Yocca -- Matthew Macaluso, Michael Krams and Sheldon H. Preskorn -- Douglas E. Feltner and Kenneth R. Evans -- Judith Dunn, Penny Randall and Amir Kalali -- Craig H. Mallinckrodt, William R. Prucka and Geert Molenberghs -- Nuala Murphy -- Joseph Kwentus -- Ginette Nachman -- Leslie Citrome -- Philip D. Harvey and Richard S.E. Keefe -- Penny Randall, Judith Dunn and Amir Kalali.
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.
9780511977640 (ebook)
Central nervous system stimulants--Development.
RM301.25 / .E82 2012
615.1/9
Title from publisher's bibliographic system (viewed on 05 Oct 2015).
History of CNS drug development / Regulatory issues / Essential CNS drug development : pre-clinical development / Phase I trials : from traditional to newer approaches / Phase II development and the path to personalized medicine in CNS disease / CNS drug development : Phase III / Statistics issues relevant to CNS drug development / Clinical trials management at company level / Clinical trials management at the site level / Medical writing for CNS indications / Dissemination of clinical trial information : multiple audiences, multiple formats / The importance of treating cognition in schizophrenia and other severe mental illnesses : background, strategies, and findings to date / Leveraging disruptive technologies to drive innovation in CNS clinical drug development / Sheldon H. Preskorn -- Gwen L. Zornberg -- Alan J. Cross and Frank D. Yocca -- Matthew Macaluso, Michael Krams and Sheldon H. Preskorn -- Douglas E. Feltner and Kenneth R. Evans -- Judith Dunn, Penny Randall and Amir Kalali -- Craig H. Mallinckrodt, William R. Prucka and Geert Molenberghs -- Nuala Murphy -- Joseph Kwentus -- Ginette Nachman -- Leslie Citrome -- Philip D. Harvey and Richard S.E. Keefe -- Penny Randall, Judith Dunn and Amir Kalali.
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.
9780511977640 (ebook)
Central nervous system stimulants--Development.
RM301.25 / .E82 2012
615.1/9