Safety Evaluation of Pharmaceuticals and Medical Devices

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, ATS, is the principal of Gad Consulting Services, a seventeen year old consulting firm with six employees and more than 450 clients (including 120 pharmaceutical companies in the US and 50 overseas). Prior to this, he served in director-level and above positions at Searle, Synergen and Becton Dickinson. He has published 39 books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He has more than 33 years of broad based experience in toxicology, drug and device development, statistics and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award. He has direct involvement in the preparation of INDs (90 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. He has consulted for FDA, EPA and NIH, and has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 19 years.

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.