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Timing of Toxicological Studies to Support Clinical Trials, The - edizione con copertina flessibile

2008, ISBN: 9780792388722

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1994, ISBN: 9780792388722

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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… Altro …

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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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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 - copertina rigida, flessible

1995, ISBN: 0792388720

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

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Dettagli del libro
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.

Informazioni dettagliate del libro - The Timing of Toxicological Studies to Support Clinical Trials (CMR Workshop)


EAN (ISBN-13): 9780792388722
ISBN (ISBN-10): 0792388720
Copertina rigida
Copertina flessibile
Anno di pubblicazione: 1995
Editore: Parkinson, C. McAuslane, N. Lumley, C. Walker, S.R. Springer
172 Pagine
Peso: 0,426 kg
Lingua: eng/Englisch

Libro nella banca dati dal 2007-11-02T15:45:07+01:00 (Zurich)
Pagina di dettaglio ultima modifica in 2023-11-03T00:15:01+01:00 (Zurich)
ISBN/EAN: 0792388720

ISBN - Stili di scrittura alternativi:
0-7923-8872-0, 978-0-7923-8872-2
Stili di scrittura alternativi e concetti di ricerca simili:
Autore del libro : lumley, parkinson, tim walker
Titolo del libro: the timing toxicological studies support clinical trials, proceedings


Dati dell'editore

Autore: C. Parkinson; N. McAuslane; C. Lumley; S.R. Walker
Titolo: The Timing of Toxicological Studies to Support Clinical Trials
Editore: Springer; Springer Netherland
150 Pagine
Anno di pubblicazione: 1995-01-31
Dordrecht; NL
Lingua: Inglese
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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