Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.
The Third Edition explores these key current trends:
global device markets
continually advancing technology
the...
Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ens...
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...
The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or it...
The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. "Contract Research and Development Organizations: Their Role in Global...
The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecu...
Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard particularly in individuals with compromised or limited organ system functions.
Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author s more than 30 years of direct experience, the book incorporates tricks...
Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic ef...
Animal Models in Toxicology is a single-source reference for the use of animal models in toxicology. Chapters cover nine species used in toxicology and experimental biology. With contributions from experts in toxicology, toxicological pathology, and species-specific metabolism, each of these chapters provides an excellent introductory "course" along with guidance to the literature for a more detailed understanding.
This edition includes five new chapters. The first of these provides specific and detailed guidance on the humane, efficient, and effective performance...
Animal Models in Toxicology is a single-source reference for the use of animal models in toxicology. Chapters cover nine species u...
