[PCL102H1] - Final Exam Guide - Everything you need to know! (105 pages long)

• School: UTSG
• Department: Pharmacology and Toxicology
• Course: PCL102H1
• Professor: Rebecca Laposa

Document Summary

Identification and validation of a drug target a molecule involved in the disease that the drug binds to, often inactivating it. Identification of a lead compound a chemical compound that is likely to be therapeutically useful. Lead optimization modification of the lead compound. Identification of a drug candidate not approved to be marketed yet but a good candidate. Ind (investigational new drug application: filed with the food and drug administration (fda, contains detailed information about composition of drug, clinical plans and physicians conducting the trails, purpose: permission to test drug in humans for the first time. Nda (new drug application: ask permission from legal governments -> file new drug application (takes 6-12 months) -> if approved, it becomes available to the public. Long term surveillance: pharmacovigilance monitoring of drug safety under actual conditions of use in large numbers of patients, no fixed duration, drug can be withdrawn from the market if it does not sustain the requirements (costly)