Supplements/ FDA Flashcards
FDA does not regulate
Prescribing
FDA Clinical trials:
Pre-clinical trial
Then drug approved for human testing:
Phase 1: 20-80 participants
Phase 2: 100-300 participants
Phase 3: 1000-3000 participants- drug submitted for FDA approval
*FDA review and confirm safety and effectiveness
Phase 4: 1000+ participants with approved drug
Food drug incompatibilities
Warfarin
MAOI
Metronidazole
Warfarin interacts with foods high in vit K
MAOIs interact with foods high in tyramine
Metronidazole interacts with alcohol
Women of childbearing age need ____ folic acid
400mcg daily
If pregnant: 600mcg
Vitamin A
Bone growth, immune function, cell division
Vitamin B
Deficiency can lead to wenickes encephalopathy
Phytomedicine
The practice of using plants or plant parts for therapeutic value
Generic equivalents
Consult FDA orange book