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Edited By Parkinson,Christopher Etc:

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

2008, ISBN: 9780792388722

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Edited By Parkinson,Christopher Etc:

Timing of Toxicological Studies to Support Clinical Trials, The - eerste uitgave

1994, ISBN: 9780792388722

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C. / Parkinson, Christopher Parkinson:
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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… Meer...

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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, - gebruikt boek

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 - gebonden uitgave, pocketboek

1995, ISBN: 0792388720

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

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Bibliografische gegevens van het best passende boek

Bijzonderheden over het boek
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.

Gedetalleerde informatie over het boek. - The Timing of Toxicological Studies to Support Clinical Trials (CMR Workshop)


EAN (ISBN-13): 9780792388722
ISBN (ISBN-10): 0792388720
Gebonden uitgave
pocket book
Verschijningsjaar: 1995
Uitgever: Parkinson, C. McAuslane, N. Lumley, C. Walker, S.R. Springer
172 Bladzijden
Gewicht: 0,426 kg
Taal: eng/Englisch

Boek bevindt zich in het datenbestand sinds 2007-11-02T15:45:07+01:00 (Amsterdam)
Detailpagina laatst gewijzigd op 2023-11-03T00:15:01+01:00 (Amsterdam)
ISBN/EAN: 0792388720

ISBN - alternatieve schrijfwijzen:
0-7923-8872-0, 978-0-7923-8872-2
alternatieve schrijfwijzen en verwante zoekwoorden:
Auteur van het boek: lumley, parkinson, tim walker
Titel van het boek: the timing toxicological studies support clinical trials, proceedings


Gegevens van de uitgever

Auteur: C. Parkinson; N. McAuslane; C. Lumley; S.R. Walker
Titel: The Timing of Toxicological Studies to Support Clinical Trials
Uitgeverij: Springer; Springer Netherland
150 Bladzijden
Verschijningsjaar: 1995-01-31
Dordrecht; NL
Taal: Engels
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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