Lecture 13 Drug Testing

How many phases of premarket clinical trials?

3 phases

Fast track for drugs in what situation?

serious condition with unmet need

Breakthrough therapy for drugs in what situation?

- substantial improvement of a drug in safety, efficacy, compliance of a drug

Accelerated approval of a drug based on what?

surrogate endpoint, not actual disease/therapy outcome

Priority review in drug approval based on what?

significant improvement in some area of a drug

Purpose of phase I of drug testing

Safety trial -- not for efficacy of the drug but to make sure if drug is used at designed dosing range in young, healthy people that it is reasonably safe

Purpose of phase II trial

test the efficacy of the drug for intended purpose--emphasizes near perfect compliance and adherence to treatment

Phase III trial purpose

effectiveness trial for drugs mimicking real clinical practice

How long do drug companies get patent protection for a developed drug?

10 years

How can companies extend patent protection of their drug?

pure enantiomers

Each drug has 3 types of names

- chemical
- generic/non-proprietary
- trade/proprietary

Does FDA require additional testing for generic drugs? Biosimilar drugs?

No, yes

Does FDA in USA regulate how doctors use drugs?

no

Why are some drugs taken off market after FDA approval?

- missed toxicity (rare side effects)
- drug interactions
- non-compliance
- manufacture problem

Withdrawal of drugs explain

- Manufacturer voluntarily chooses to withdraw batch of product b/c of minor violation -- not FDA. violation

Recall of drugs explain

FDA initiates this due to significant patient endangerment

Black box labeling

FDA issues additional warnings for therapeutic agents