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Pharmaceutics Spring 2016 > Bioavailability > Flashcards

Flashcards in Bioavailability Deck (48)
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31

Approved Drug Products with Therapeutic Equivalence Evaluations=

Orange Book

32

____ code are therapeutically equivalent

A

33

Therapeutically equivalent =

bioequivalent (similar rate and extent of absorption)

34

T/F Therapeutic effect is tested in the Orange Book

FALSE: NOT

35

RLD abbreviation?

reference listed drug

36

B codes

NOT therapeutically equivalent

37

______ is the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action

bioavailability

38

For drug products that ARE not intended to be absorbed in to the blood stream bioavailability.....

may be assessed by measurements intended to reflect rate and extent

39

____ is the absence of a significant difference in the rate at which or extent to which the active ingredient is pharmaceutical equivalent or alternative becomes

bioequivalence

40

T/F A product may also be considered bioequivalent to an innovator product if the difference in rate of absorption of the drug between the two products is intentional

TRUE

41

_____ a finished dosage form that contains an active ingredient

drug product

42

narrow therapeutic index.: there is less than ____ difference in median lethal dose and median effective dose values for a drug product

2-fold

43

To safely and effectively use drug products with narrow therapeutic index require (2)

-careful dosage titration
-patient monitoring

44

______ drug products that contain the SAME active ingredient, are of the same dosage form, route of administration and are identical in strength

pharmaceutical equivalents

45

T/F pharmaceutical equivalents are NOT allowed to differ in shape, scoring configuration, excipients, release mechanism

FALSE: are (they can not differ in strength, quality, purity and identity)

46

________ drug products contain the same THERAPEUTIC MOIETY, but different SALTS, ESTERS, or complexes of that moiety

pharmaceutical alternatives

47

T/F Different dosage forms and strengths within a product line by a single manufacturer are thus pharmaceutical alternatives

TRUE

48

Therapeutic equivalents are expected to have the same ____ and ______ when administered to patients under the conditions specified in the labeling

clinical effect and safety profile