EQUIVALENCE AND BODY SYSTEMS Flashcards
Select all that apply
In order to be pharmaceutically equivalent, drug products must have the same:
a) active ingredients
b) inactive ingredients
c) dosage form and strength
d) mechanism of release
e) route of administration
a) active ingredients
c) dosage form and strength
e) route of administration
Drug products that contain the same drug moiety, but may have different forms or strengths are:
a) Pharmaceutical equivalents
b) Pharmaceutical alternatives
c) Therapeutic equivalents
d) Bioavailability
b) Pharmaceutical alternatives
__________ is the measure of the rate and extent to which the active ingredient is absorbed from a dosage form and becomes available at the desired site of action.
Bioavailability
__________ describes pharmaceutical equivalent or pharmaceutical alternative products that display comparable bioavailability when studied under similar experimental conditions.
Bioequivalence
In order for two drugs to be therapeutic equivalents, they first must be:
a) pharmaceutical alternatives and be bioavailable
b) pharmaceutical alternatives and be bioequivalent
c) pharmaceutical equivalents and be bioequivalent
c) pharmaceutical equivalents and be bioequivalent
True or False
Two drugs can only be therapeutic equivalents if their inactive ingredients are identical.
False
active ingredients are identical
To be classified as therapeutic equivalents by the FDA, drugs products must meet which of the following criteria:
a) they are bioequivalent and adequately labeled
b) they are pharmaceutical equivalents
c) they are bioavailable
d) they are approved as safe and effective
e) they are in compliance with Current Good Mfc. Practice regulations
f) they are pharmaceutical alternatives
a) they are bioequivalent and adequately labeled
b) they are pharmaceutical equivalents
d) they are approved as safe and effective
e) they are in compliance with Current Good Mfc. Practice regulation
What is the difference between pharmaceutical equivalents and therapeutic equivalents?
Therapeutic equivalents must also be bioequivalent.
For an applicant drug to be considered bioequivalent to a standard drug, it must be within what percentage range compared to the standard drug bioavailability?
a) -20%/+20%
b) -15%/+25%
c) -20%/+20%
d) -20%/+25%
d) -20%/+25%
What is the actual name of the “orange book”?
Approved Drug Products with Therapeutic Equivalence Evaluations
What is another name for the Approved Drug Products with Therapeutic Equivalence Evaluations resource book?
Orange book
Define the acronym DESI.
Drug Efficacy Study Implementation
What does the letter “A” indicate for drugs in the orange book?
Drug is a therapeutic equivalent product.
What does the letter “B” indicate for drugs in the orange book?
Drugs that are not considered to be equivalent.
Orange Book Ratings.
Drugs which are not considered to have the potential for equivalence problems.
a) AA
b) AB
c) AP
d) AT
a) AA
Orange Book Ratings.
Drugs which have shown, through testing that they are equivalent.
a) AA
b) AB
c) AN
d) AO
b) AB
Orange Book Ratings.
Equivalent solutions and powders for intended aerosolization.
a) AO
b) BP
c) AN
d) AA
c) AN
Orange Book Ratings.
Equivalent injectable oil solutions whose active ingredients and vehicle are identical.
a) AT
b) AP
c) BN
d) AO
d) AO
Orange Book Ratings.
Drugs which are not considered to have the potential for equivalence problems.
a) AP
b) AN
c) AT
d) AB
c) AT
Orange Book Ratings.
Equivalent topical products.
a) AT
b) AP
c) AA
d) AN
b) AP
Orange Book Ratings.
Indicates further testing is needed on a product already assigned to A or B.
a) B*
b) BX
c) BE
d) BT
a) B*
Orange Book Ratings.
Drugs shown to be non-equivalent in bioequivalence studies.
a) BT
b) BS
c) BP
d) BD
d) BD
Orange Book Ratings.
Non-equivalent drug due to presumed differences in delayed release dosage form.
a) BD
b) BE
c) BT
d) B*
b) BE
Orange Book Ratings.
Non-equivalence due to a presumed difference in extended release dosage forms.
a) BS
b) BT
c) BX
d) BC
d) BC
