History/intro Flashcards
top 5 medical breakthroughs
- vaccines
- germ theory
- genetics
- penicillin
- x-ray
what is pharmacokinetics
what body does to drug
what is pharmacodynamic
what drug does to body
what is trend for drug discovery at present
more money spent on dev. and less drugs being made
what 3 aspects of a drug does health canada look at
- safety
- efficacy
- quiality
ratio of possible drugs to drugs that go to market
1:10000
5 phases of drug dev
- preclinical 1-4
what is preclinical testing
no human, look at kinetics, interactions, animal studies
what is phase 1 in terms of pop and N, criteria and aim
- first time in humans (all healthy)
- small N
- controlled population
- exmains safety and kinetics
what is phase 2 in terms of pop and N, criteria and aim
- first time in PTs
- N of 100s
- controlled criteria
- proof of concept
what is phase 3 in terms of pop and N, criteria and aim
- more complex PTs
- N of 1000s
- still controlled inclusion/exclusion
- expensive
what is phase 4 in terms of pop and N, criteria and aim
post marketing surveillance
what is in a NDS (new drug submission)
ALL data about drug and how it will be sold/used
what is bioequivalence
must hit a Cmax of 80-125% of original drug
what is supplemental NDS
required to make change to existing drug
