Drug Regulation, Development, Etc. Flashcards
What is the major reason for the Permission of accelerated drug approval?
To append up drug approval for important medications (cancer)
What are the landmark drug legislation?
Federal pure food and drug act (1906) Food, drug and cosmetic act (1938) Harris-Kefauver amendments (1962) Controlled substance act (1970) Permission of accelerated drug approval (1992)
DEA developed 5 schedules regarding controlled substance. What are they?
I high potential for abuse/not accepted (heroin)
II high potential for abuse but a medical use
III moderate potential for abuse
IV low potential
V lowest potential
Which two schedules does pain medication and morphine fall into?
Schedule II and schedule III
Although schedule v is safest, can abuse still occur?
Yes, but much less
In new drug development what type of trail must occur?
The randomized controlled trail.
In randomized controlled trail what three types of trail occur?
Control
Randomization
Blinding
What is control use?
Control/experimental group. Current treatment or placebo.
What is randomization?
Patient can not make decision on taking drug or placebo. It is assigned.
What is blinding?
No one knows who is in which group.
What are the stages of new drug development?
Preclinical testing
Clinical testing
How many phases are there in clinical testing?
IV phases
What is phase IV used for in new drug development?
Postmarking surveillance
What is used for testing in preclinical testing?
Animals
What is used in clinical testing?
Humans
How many species must be used for testing in preclinical?
Two
In phase I how many healthy volunteers must be in the study and what is being tested?
50, safety and dosage
In phase II how many patients must be in the study and what is being tested?
200-500, evaluate effectiveness
In phase III how many patients must be in the study and what is being tested?
2,000-5,000, confirm effectiveness common side effects.
In phase IV what is being tested?
Common and rare side-effects
In phase IV, post-market surveillance, what should be occurring?
Doctors are supposed to report side effects.
Large scale trials should continue
What are the limitations of testing procedure?
Limited info on women and children
Failure to detect all adverse side effects.
What should be added to a hand written prescription and why?
Generic name so patient can read there own prescription.
What are the three types of drug names?
Chemical
Generic
Trade
