module 1 Flashcards
what is pharmacology?
the study of drugs that involves route of administration, how the drug works, therapeutic effects and adverse effects
what is a drug?
traditional drugs or chemical agent
what is a biologic?
antibodies or hormones
what is a natural health products?
herbals, vitamins and minerals
how long does drug approval take in canada?
15 years
how much does total cost of a new drug cost?
800000000 (eight hundred million)
what happens during the drug discovery/preclinical testing?
-in cultured cells, living tissue or experimental animals
-evaluate biological effects, pharmacokinetics, toxicity
-6.5 years
what happens during clinical trial application?
application submitted through health canada, involves alot of paperwork and h
phase 1 clinical trial
20-100 volunteerrs
one year
phase 2 clinical
300-500 sick
2 years
phase 3
500-5000 pt
4 years
new drug submission
report about how well the drug works and safety
1.5 years
phase 4
continues after drug is monitored
what is an eteral drug
involves GI tract
what does the rough endoplasmic recticulum do?
synthesizes proteins