Safety evaluation of pharmaceuticals and medical devices: international regulatory guidelines

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 ISOanalog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicineand 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. Nonclinical safety assessment tests Large molecules biotechnology products National differences INDICE: Preface.- 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.- Appendix A.-INDEX.

• ISBN: 978-1-4419-7448-8
• Editorial: Springer
• Encuadernacion: Cartoné
• Páginas: 98
• Fecha Publicación: 29/11/2010
• Nº Volúmenes: 1
• Idioma: Inglés