Dugga 2 - chapter 15 Flashcards
1
Q
What does bioavaliability mean?
A
The fraction of administred drug that reaches the blood supply in a set period of time.
2
Q
What does bioequivalence studies mean?
A
Studies on how the bioavaliability remains the same even as there are alterations to the manufacturing, formulation or storage processes
3
Q
Phase 1 studies
A
4
Q
Phase 2 studies
A
5
Q
Phase 3 studies
A
6
Q
Phase 4 studies
A
7
Q
Regulatory affairs
A
FDA and EMEA
8
Q
Orphan drugs
A
Drugs thatr are effective against relatively rare medical problems less than 200 000 people.
9
Q
GLP and GMP
A
