Safety Evaluation of Pharmaceuticals and Medical Devices : International Regulatory Guidelines - Gad, Shayne C.; SpringerLink (Online service) (New York, NY : Springer US : Imprint: Springer, 2011)
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.
Keywords: Pharmacology; Pharmaceutical technology; Pharmacy; Pharmacology/Toxicology.; Pharmaceutical Sciences/Technology.; Pharmacy