Biavaliablity

Question 0

Food and drug act of 1906 established standard for ______ and ______

Answer 0

Strength

Purity

Question 1

Bioavailability equation

Answer 1

Quantity if drug reach systemic circulation / quantity of drug administered

Question 2

1938 federal food drug and cosmetic act required manufacture to prove _____, and new drug are referred to as ______

Answer 2

Safety

Active ingredient

Question 3

The Kefauver Harris amendment ensured drug _______

Answer 3

Efficacy

Question 4

_______ reviewed drug market between 1938 and 1962

Answer 4

Drug efficacy study implementation (DESI)

Question 5

The abbreviated drug application ANDA allows for drug discovered between 1938 and 1962 to be _______

Answer 5

Reviewed

Question 6

The orange book evaluates the ________ of generic drug

Answer 6

Therapeutic equivalence

Question 7

4 criteria for pharmaceutical equivalent

Answer 7

Same active ingredient
Same dosage form
Same route of administration
Identical in strength and concentration

Question 8

Therapeutically equivalent drug product does not include drug from before _____, and get must be approved as both _____ by the FDA

Answer 8

1962

Safe and effective

Question 9

According to FDA rating system, in order to ensure bioequivalency, the drug must have no problem in ________ standard, if there is problem, it must meet _____ standard

Answer 9

In vitro

In Vivo

Question 10

Define bioavailability

Answer 10

The rate and extent which the active ingredient in pharmaceutical equivalent become available at the site of drug action

Question 11

Defiant bioequivalence

Answer 11

The relative measure of bioavailability of two products

Question 12

The ____ value is most useful to measure rate of absorption

Answer 12

Cmax

Question 13

_____ is used to measure extent of absorption

Answer 13

AUC

Question 14

AA product include _____ product that has no bioequivalency problem, and no _____ were performed comparing innovator and generic version

Answer 14

Innovator

Bioequivalency testing

Question 15

An AB product meets the necessary bioequivalence requirement. Actual or potential ____have been resolved through scientific testing

Answer 15

Bioequivalence problem

Question 16

BD products’ active ingredient and dosage form has documented _______, while BP products has _______

Answer 16

Bioequivalence problem

Potential bioequivalence problem

Question 17

BX products’ data has been reviews by the FDA but are ______ to determine therapeutic equivalence

Answer 17

Insufficient