Safety Pharmacology in Pharmaceutical Development and ApprovalCRC Press, 2003 M08 26 - 208 pages The Propulsid and Seldane drug disasters could have easily been avoided with more rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology has been overlooked by all but a few developers. With recent drug withdrawals from the market and the implementation of the International Con |
Contents
background history issues and concerns | 1 |
2 Regulatory requirements of ICH US FDA EMEA and Japan MHW | 17 |
3 Principles of screening and study design | 23 |
4 Cardiovascular system | 43 |
5 Central nervous system | 65 |
6 Respiratory system | 81 |
7 Renal function | 95 |
Other editions - View all
Safety Pharmacology in Pharmaceutical Development and Approval Shayne C. Gad No preview available - 2003 |
Common terms and phrases
absorption action activity acute addition administered adverse agents alter analysis animals antibodies antigen approach assay assessment associated autoimmunity blood body cardiovascular cause cells changes clearance clinical collected complex compounds concentration conducted considered decrease detect determine disease dose drugs effects endpoints evaluation example excretion exposure expression factors flow function guidelines humans hypersensitivity immune immune system important increase individuals induce injection interaction interval intestinal involved limit means measured mechanisms methods models normal observed occur organ parameters particular patients performed pharmaceutical Pharmacol plasma potential preclinical present pressure procedure production prolongation range reactions renal respiratory response result risk safety pharmacology safety pharmacology studies screen secretion selected sensitivity signals single solute specific standard stimulation studies substance Table techniques therapeutic tion tissue toxicity Toxicol toxicology types urine usually variability vivo volume York