BPS 1101 Lecture Notes - Lecture 14: Sodium Benzoate, Pharmacovigilance, Nuremberg Code

• School: University of Ottawa
• Department: Biopharmaceutical sciences
• Course: BPS 1101
• Professor: William Ogilvie

Document Summary

Many barriers for drugs geing into the body. Drugs work correctly in the wrong place. Eg aspirin relieves muscle pain but gives stomach irritaion. Drug interacts with wrong biological molecule eg anihistamines relieve. Drug safety tesing allergy symptoms but cause drowsiness: iniial tesing done roboically in vitro, safety tesing in animals and primates (60,000,000/year. ) Pro-test movement: all animal tesing subject to ethical review. Pills contain more than just the drug: excipient (any substance added to pill that isn"t the drug substance. Usually added to turn the drug into a product. Could be illers, stabilizers, colours, lavours, etc. : preservaives protect drug from microbes, stabilizers protect it from oxygen, fillers dilute the drugs and are important for safety, colours are a safety feature. Clinical trials: tesing for eicacy (does it work?) 90% failure rates: phase 1 safety test. Uses 100 healthy volunteers to check for big problems: phase 2 safety & eicacy & dosage. 100-300 paients: phase 3 thousands of paients.