Safety Evaluation of Pharmaceuticals and Medical Devices : International Regulatory Guidelines
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : Shayne Cox Gad
- ناشر : New York : Springer
- چاپ و سال / کشور: 2011
- شابک / ISBN : 9781441974488
Description
Introduction to Safety Assessment in Drug and Medical Device Development -- Drugs: The General Case 23-44 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.
