Drug Regulation Flashcards
At what step is equivalency determined for generic vs non generic drugs?
Absorption.
Federal Govt determines
Which drugs can be proscribed.
Stat Govt determines
Who can proscribe drugs
What is the highest, most potent “schedule” of drug?
Schedule I.
Not for medical use
True/False: Schedule 2 drugs can be phoned in and refilled
False
What is the purpose for animal studies of a drug?
1)attempt to find appropriate dosage and 2) use
What is the purpose for phase I studies of a drug?
Is it safe?
Administer to healthy individuals
Evaluate SAFETY
What is the purpose for phase II studies of a drug?
Does it work?
Evaluate SAFTEY and EFFICACY
What is the purpose for phase III studies of a drug?
Does it work double blind?
EFFICACY AND SAFETY measured.
Adverse reactions measured for long term use.
What categories are scheduled drugs classified into?
Medical Use
Abuse potential
Psych Dependance
Phsyio Dependance