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Edited By Parkinson,Christopher Etc:

Timing of Toxicological Studies to Support Clinical Trials, The - Paperback

2008, ISBN: 9780792388722

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Edited By Parkinson,Christopher Etc:

Timing of Toxicological Studies to Support Clinical Trials, The - First edition

1994, ISBN: 9780792388722

Paperback

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The Timing of Toxicological Studies to Support Clinical Trials by C. / Parkinson, Christopher Parkinson - C. / Parkinson, Christopher Parkinson
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The Timing of Toxicological Studies to Support Clinical Trials by C. / Parkinson, Christopher Parkinson - used book

ISBN: 9780792388722

The timing of toxicological studies in relation to the clinical evaluation of new medicines is a key topic for strategic planners in the industry and those involved with harmonisation. Re… More...

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Timing of Toxicological Studies to Support Clinical Trials : Proceedings : C. M. R. Discussion Meeting on the Timing of Toxicological Studies (1994 : Nutfield, - Christopher Parkinson
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Christopher Parkinson:
Timing of Toxicological Studies to Support Clinical Trials : Proceedings : C. M. R. Discussion Meeting on the Timing of Toxicological Studies (1994 : Nutfield, - used book

1994, ISBN: 9780792388722

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The Timing of Toxicological Studies to Support Clinical Trials - Parkinson, C. (Herausgeber); Walker, S. R. (Herausgeber); Lumley, C. (Herausgeber); McAuslane, N. (Herausgeber)
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Parkinson, C. (Herausgeber); Walker, S. R. (Herausgeber); Lumley, C. (Herausgeber); McAuslane, N. (Herausgeber):
The Timing of Toxicological Studies to Support Clinical Trials - hardcover

1995, ISBN: 0792388720

1994 Gebundene Ausgabe Pharmakologie, clinicaltrial; efficiency; Pharmacology; research; Toxicity, mit Schutzumschlag 11, [PU:Springer Netherlands; Springer Netherland]

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Bibliographic data of the best matching book

Details of the book
The Timing of Toxicological Studies to Support Clinical Trials (CMR Workshop)

The timing of toxicological studies in relation to the clinical evaluation of new medicines is a key topic for strategic planners in the industry and those involved with harmonisation. Resolving the anomalies between different regulatory authorities should eliminate redundant testing on animals and improve the efficiency of the developmental process by encouraging single international strategies. To aid industry in reaching a consensus, the Centre for Medicines Research brought together representatives of the pharmaceutical industry from Europe, Japan and the U.S.A., to give a comprehensive account of current international industry positions on the subject. The contributions review the situation and address the clinical and strategic requirements of the preclinical programme. Personal and consensus proposals on the toxicity studies required to initiate clinical investigations, the timing of reproductive toxicity tests and the duration of repeat-dose studies to support clinical development are provided.

Details of the book - The Timing of Toxicological Studies to Support Clinical Trials (CMR Workshop)


EAN (ISBN-13): 9780792388722
ISBN (ISBN-10): 0792388720
Hardcover
Paperback
Publishing year: 1995
Publisher: Parkinson, C. McAuslane, N. Lumley, C. Walker, S.R. Springer
172 Pages
Weight: 0,426 kg
Language: eng/Englisch

Book in our database since 2007-11-02T10:45:07-04:00 (New York)
Detail page last modified on 2023-11-02T19:15:01-04:00 (New York)
ISBN/EAN: 0792388720

ISBN - alternate spelling:
0-7923-8872-0, 978-0-7923-8872-2
Alternate spelling and related search-keywords:
Book author: lumley, parkinson, tim walker
Book title: the timing toxicological studies support clinical trials, proceedings


Information from Publisher

Author: C. Parkinson; N. McAuslane; C. Lumley; S.R. Walker
Title: The Timing of Toxicological Studies to Support Clinical Trials
Publisher: Springer; Springer Netherland
150 Pages
Publishing year: 1995-01-31
Dordrecht; NL
Language: English
106,99 € (DE)
109,99 € (AT)
118,00 CHF (CH)
Available
XVI, 150 p.

BB; Hardcover, Softcover / Medizin/Pharmazie; Pharmakologie; Verstehen; clinical trial; efficiency; pharmacology; research; toxicity; Pharmacology; Public Health; Public Health und Präventivmedizin; BC

Section I: Introduction and Presentations.- 1 The application of toxicological investigations in the safe development of medicines.- 2 Review of international recommendations on animal toxicity studies and their relation to clinical exposure.- 3 International survey on the timing of toxicity studies in relation to clinical trials.- 4 Considerations for implementing a toxicity testing strategy.- Section II: Personal Views.- 5 Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? — a toxicologist’s opinion.- 6 Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? — a clinical pharmacologist’s opinion.- 7 The duration of toxicity studies required to support repeated dosing in clinical investigation —a toxicologist’s opinion.- 8 The duration of toxicity studies required to support repeated dosing in clinical investigation — a clinician’s opinion.- 9 Reproductive and developmental toxicity studies required to support the inclusion of women and children in clinical trials — a toxicologist’s opinion.- Section III: Proposals and the Way Forward.- 10 The minimum non-clinical package for initiating Phase I clinical trials.- 11 The duration of toxicity studies to support repeated dosing in clinical investigation.- 12 The timing of reproductive toxicity studies in relation to clinical trials.- The way forward.- 14 Input to ICH.- Meeting participants.

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