Timing of Toxicological Studies to Support Clinical Trials

Inbunden, Engelska, 1995

Av C. Parkinson, N. McAuslane, C. Lumley, S.R. Walker, S. R. Walker

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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 harmonization. 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 has brought together representatives of the pharmaceutical industry from Europe, Japan and the USA to give a comprehensive account of current international industry positions on the subject. The contributions in this text review the situation and address the clinical and strategic requirements of the pre-clinical 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.

Produktinformation

Utgivningsdatum1995-01-31
Mått155 x 235 x 15 mm
Vikt430 g
FormatInbunden
SpråkEngelska
Antal sidor150
Upplaga1994
FörlagKluwer Academic Publishers
ISBN9780792388722

Tillhör följande kategorier

Samhällsmedicin och preventiv medicin inom Medicin
Tillverkningsteknik inom Naturvetenskap och teknik
Farmakologi inom Medicin

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.