PHASES OF DRUG DEVELOPMENT

Question 1

how many phases?

Answer 1

4

Question 2

name this phase:

safety and tolerability
20-100 healthy human subjects
pharmacokinetic measurements

70% of drugs move to the next phase

Answer 2

phase I clinical pharmacology

Question 3

name this phase:

efficacy and safety
optimal dose range
100-200 subjects

33% of the drugs move to the next phase

Answer 3

phase II clinical investigation

Question 4

name this phase:

confirms efficacy of drug and detect undiscovered effects providing most of the safety data

300-3000 subjects

goat is to demonstrate whether the drug offers a treatment benefit to a specific population

*must have an NDA (new drug application) submitted to the FDA

25-50% success rate

Answer 4

phase III clinical trials

Question 5

name this phase:

purpose studies the adverse effects, compliance, drug-drug interactions

many ADRs and drug interactions are discovered after marketing because these are the rare side effects

Answer 5

phase IV post marketing