Format:
Online-Ressource (XII, 128p. 2 illus. in color, digital)
ISBN:
9781441974495
Series Statement:
SpringerLink
Content:
The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
Note:
Includes bibliographical references and index
,
Safety Evaluation of Pharmaceuticals and Medical Devices; Preface; Contents; Introduction to Safety Assessment in Drug and Medical Device Development; Drugs: The General Case; IND-Enabling Toxicology Programs; Nonclinical Safety Evaluation Studies Conducted to Support Continued Clinical Development; Supporting Marketing Applications; Special Therapeutic Category and Route of Administration Cases; Device Safety Evaluation; About the Author; Appendix A Notable Regulatory Internet Addresses; Index;
Additional Edition:
ISBN 9781441974488
Additional Edition:
Buchausg. u.d.T. ISBN 978-1-441-97448-8
Language:
English
Subjects:
Chemistry/Pharmacy
DOI:
10.1007/978-1-4419-7449-5
URL:
Volltext
(lizenzpflichtig)
