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Edited By Parkinson,Christopher Etc:

Timing of Toxicological Studies to Support Clinical Trials, The - Livro de bolso

2008, ISBN: 9780792388722

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Edited By Parkinson,Christopher Etc:

Timing of Toxicological Studies to Support Clinical Trials, The - primeira edição

1994, ISBN: 9780792388722

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C. / Parkinson, Christopher Parkinson:
The Timing of Toxicological Studies to Support Clinical Trials by C. / Parkinson, Christopher Parkinson - livro usado

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… mais…

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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, - livro usado

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 - encadernada, livro de bolso

1995, ISBN: 0792388720

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

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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.

Dados detalhados do livro - The Timing of Toxicological Studies to Support Clinical Trials (CMR Workshop)


EAN (ISBN-13): 9780792388722
ISBN (ISBN-10): 0792388720
Livro de capa dura
Livro de bolso
Ano de publicação: 1995
Editor/Editora: Parkinson, C. McAuslane, N. Lumley, C. Walker, S.R. Springer
172 Páginas
Peso: 0,426 kg
Língua: eng/Englisch

Livro na base de dados desde 2007-11-02T12:45:07-02:00 (Sao Paulo)
Página de detalhes modificada pela última vez em 2023-11-02T20:15:01-03:00 (Sao Paulo)
Número ISBN/EAN: 9780792388722

Número ISBN - Ortografia alternativa:
0-7923-8872-0, 978-0-7923-8872-2
Ortografia alternativa e termos de pesquisa relacionados:
Autor do livro: lumley, parkinson, tim walker
Título do livro: the timing toxicological studies support clinical trials, proceedings


Dados da editora

Autor: C. Parkinson; N. McAuslane; C. Lumley; S.R. Walker
Título: The Timing of Toxicological Studies to Support Clinical Trials
Editora: Springer; Springer Netherland
150 Páginas
Ano de publicação: 1995-01-31
Dordrecht; NL
Peso: 0,930 kg
Língua: Inglês
106,99 € (DE)
109,99 € (AT)
118,00 CHF (CH)
POD
XVI, 150 p.

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

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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