BCS/Bioequivalence

Question 1

what does MTC stand for?

Answer 1

maximum tolerated concentration

Question 2

define bioavailability

Answer 2

the rate and extent to which an active drug ingredient
is absorbed and becomes available at the site of action

Question 3

define pharmaceutical equivalence

Answer 3

drug products with identical amounts of identical active drug ingredient in identical dosage forms but not necessarily containing same inactive ingredients

Question 4

define pharmaceutical alternative

Answer 4

drug products with identical active ingredient but not necessarily in same amount or dosage form

Question 5

define bioequivalent drug

Answer 5

equivalents or alternatives whose rate and
extent of absorption do not show a significant
difference when administered at the same dose

Question 6

what is the Biopharmaceutics Classification System (BCS)

Answer 6

a scientific framework for classifying drug
substances based on their aqueous solubility and
intestinal permeability. it takes into account dissolution, solubility, and permeability

Question 7

what is the purpose of the BCS system?

Answer 7

easier approval of generic drugs

Question 8

what is Lipinski’s rule of five?

Answer 8

1) A molecular weight of under 500
2) Fewer than 10 hydrogen-bond (H-bond) acceptors
3) Fewer than 5 H-bond donors
4) A C log P value of less than 5 (a measure of water solubility)

Question 9

what does the orange book contain?

Answer 9

approved drug products with therapeutic equivalence