عنوان

The Timing of Toxicological Studies to Support Clinical Trials

(Number (ISBN

9401046239

(Number (ISBN

9401114242

(Number (ISBN

9789401046237

(Number (ISBN

9789401114240

Number

b594850

Title Proper

The Timing of Toxicological Studies to Support Clinical Trials

General Material Designation

[Book]

First Statement of Responsibility

edited by Christopher Parkinson, Neil McAuslane, Cyndy Lumley, Stuart Walker.

Place of Publication, Distribution, etc.

Dordrecht

Name of Publisher, Distributor, etc.

Springer Netherlands : Imprint : Springer

Date of Publication, Distribution, etc.

1994

Specific Material Designation and Extent of Item

(128 pages)

Text of Note

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.

Text of Note

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.

Medicine.

Public health.

Toxicology.

Class number

Book number

edited by Christopher Parkinson, Neil McAuslane, Cyndy Lumley, Stuart Walker.

C E Lumley

Christopher Parkinson

Neil McAuslane

Stuart Walker

Electronic name

[Book]

Y