The Timing of Toxicological Studies to Support Clinical Trials
Published on 27. September 2012
Book
Paperback/Softback
XVI, 150 pages
978-94-010-4623-7 (ISBN)
Description
Over the past twelve years, the Centre for Medicines Research has held a series of Workshops on a number of topics related to the drug discovery and development process. The major objective of these Workshops has been to provide an international forum for regula tory, academic and industry representatives to debate together, and suggest solutions to, specific problems. The meeting reported in this volume represents a departure from this approach, in that the par ticipants were drawn largely from the pharmaceutical industry. Senior clinicians, pharmacologists and toxicologists from companies in Europe, the USA and Japan met in May 1994 to discuss a scientific rationale for the conduct of toxicity studies to support the clinical development of new medicines, and to begin to work towards an industry consensus. Achievement of such a consensus is seen as an important step in the process leading towards international harmon isation of the recommendations on the timing of toxicity studies in relation to clinical trials.
More details
Edition
Softcover reprint of the original 1st ed. 1994
Language
English
Place of publication
Dordrecht
Netherlands
Target group
Professional and scholarly
Research
Product notice
Paperback (trade)
Unsewn / adhesive bound
Illustrations
XVI, 150 p.
Dimensions
Height: 235 mm
Width: 155 mm
Thickness: 10 mm
Weight
271 gr
ISBN-13
978-94-010-4623-7 (9789401046237)
DOI
10.1007/978-94-011-1424-0
Schweitzer Classification
Other editions
Additional editions
C. Parkinson | N. McAuslane | C. Lumley
The Timing of Toxicological Studies to Support Clinical Trials
E-Book
12/2012
Springer
€96.29
Available for download
C. Parkinson | N. McAuslane | C. Lumley
The Timing of Toxicological Studies to Support Clinical Trials
Book
01/1995
Kluwer Academic Publishers
€106.99
Shipment within 15-20 days
Content
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.