Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

PHAR 303 > Bioequivalence (1) > Flashcards

Bioequivalence (1) Flashcards

1
Q

This model predicts oral absorption based on dissolution

A

Biopharmaceutics Classification System

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

How does the American FDA’s def’n of BIOAVAILABILITY differ from that of Canada’s TPD (Therapeutic Products Directorate) def’n?

A

FDA doesn’t directly state that it relates to the drug’s plasma concentration.

TPD’s def’n implies that bioavailability of a drug is directly related to its conc in the blood (Cp)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

T or F: Generics drive healthcare costs up.

A

F

Down

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

T or F: Following the “Hatch-Waxman Act”, generics had to prove efficacy of their products.

A

F

Efficacy was proven by the inventor company. All that generic companies had to prove was bioequivalence between their drug and and brand name drug.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What was thalidomide used to treat?

A

Morning sickness in pregnant women.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

F =

[AUC(oral)/AUC(IV)][Dose(IV)/Dose oral]

A

Absolute bioavailability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

In single dose evaluation of bioavailability, what parameters characterize rate and extent of bioavailability?

A

AUC(0-∞), Cmax, and tmax

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What is considered highly soluble under the Biopharmaceutics Classification System?

A

Soluble in < or = 250 mL aqueous media over pH 1.2-6.8 @ 37ºC

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

This model correlates in vitro dissolution w/ in vivo BA

A

Biopharmaceutics Classification System

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Do generics have the same API as the innovator drug?

A

Yes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What aspect of their drugs did generic companies have to prove after the Hatch-Waxman Act?

A

Pharmaceutical equivalence and BE (bioequivalence)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What aspect of BA is described by AUC?

A

EXTENT of absorption

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What fraction needs to be absorbed in order to be considered to have good permeability (according to the Biopharmaceutics Classification System)?

A

> or = 80%

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What is considered rapid dissolution under the Biopharmaceutics Classification System?

A

> 85% of drug dissolves within 30 mins using USP Apparatus I or II

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

In in vitro studies, drugs are classified according to what 3 criteria in the Biopharmaceutics Classification System?

A
  1. Aqueous solubility
  2. Dissolution rate
  3. Intestinal permeability
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

How many solubility-permeability drug classes are there in the Biopharmaceutics Classification System?

A

4

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

According to the Biopharmaceutics Classification System, two drugs will have the same rate and extent of absorption when… (2)

A
  1. they have the same C vs. t profile at intestinal membrane surface
  2. they have the same in vivo dissolution profile under all luminal conditions
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Can we say that two drugs are BE based on AUC data only?

A

NO, b/c while the extent of absorption may be equivalent, we know nothing about the rate of absorption

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

What are generic drugs?

A

Copies of brand-name drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

T or F: Generics drive healthcare costs down.

A

T

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

They are exact versions of the innovator product (made with same ingredients from same factory). They only differ in packaging

A

Pseudo-generics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

What did the “Hatch-Waxman Act” establish?

A

ANDA (abbreviated new drug application procedure)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

When can we waive BE studies? (5)

A
  1. Soln intended for IV use
  2. Topical drug
  3. Oral drug not meant to be absorbed
  4. Inhaled drug
  5. Drug contains no excipient known to affect BA
24
Q

In multiple dose evaluation of bioavailability, what parameters characterize rate and extent of bioavailability?

A

AUC(τn-τn+1) and % fluctuation

25
Q

Are generics intended for the same therapeutic use as the innovator drug?

A

Yes

26
Q

The extent of absorption is limited by permeability for drugs of this permeability-solubility class.

A

III

27
Q

T or F: B/w 1962 and 1984, there was a boom in generic drug production.

A

F

It was too expensive due to the Federal Food, Drug, and Cosmetic Act amendment in 1962

28
Q

This solubility-permeability drug class has a low aqueous solubility and high permeability

A

II

29
Q

What aspect of BA is described by Cmax and tmax?

A

RATE of absorption

30
Q

Most diffs in product performance b/w generics and brand names is reflected in what?

A

Dissimilar Cp vs. t

31
Q

Name 2 diffs b/w generics and brand name drugs.

A

Generics…

  1. look different
  2. are cheaper
32
Q

Name the 4 types of bioequivalence studies in order of preference by FDA/TPD.

A
  1. PK-BE (pharmacokinetic)
  2. PD-BE (pharmacodynamic)
  3. Comparative Clinical Study
  4. In Vitro study
33
Q

The extent of absorption is limited by dissolution rate for drugs of this permeability-solubility class.

A

II

34
Q

The extent of absorption is very poor for drugs of this permeability-solubility class.

A

IV

35
Q

This solubility-permeability drug class has a low aqueous solubility and low permeability

A

IV

36
Q

A biowaiver is readily gained for this permeability-solubility drug class.

A

I

37
Q

Why are two bioequivalent drugs considered interchangeable?

A

Because they’re assumed to be therapeutically equivalent

38
Q

What is the slowest step in absorption?

A

Dissolution

39
Q

What is considered highly permeable under the Biopharmaceutics Classification System?

A

Absorption is >90% of administered dose

40
Q

Why did generic companies stop developing generics after 1962?

A

Because they were req’d to prove safety, efficacy, and BE in their drugs (before 1962, only safety had to be proven)

41
Q

In 1984, the “Drug Price Competition and Patent Term Restoration Act” was brought into existence. What’s another name for this act?

A

the “Hatch-Waxman Act”

42
Q

Define “Pharmaceutical Equivalents”

A

Two drugs that…

a. have identical APIs in identical amts in comparable dosage forms
b. have diff excipients

43
Q

In the Biopharmaceutics Classification System, what drug is considered the standard for good permeability?

A

Metoprolol

44
Q

How is the American FDA’s def’n of BIOAVAILABILITY similar to that of Canada’s TPD (Therapeutic Products Directorate) def’n?

A

They both consider the rate and extent of absorption of drug.

45
Q

Are pseudo-generics more expensive than actual generics?

A

Yes.

46
Q

This solubility-permeability drug class has a high aqueous solubility and low permeability

A

III

47
Q

Do PK-BE studies use the highest or lowest dose approved for the innovator (R; reference) drug?

A

Highest

48
Q

When can we say that two drugs (test and reference drug) are bioequivalent?

A

When the rate and extent of absorption profiles for both drugs (that contain the same drug) are similar or the same.

49
Q

What two parameters does bioequivalence consider?

A
  1. Rate of absorption

2. Extent of absorption

50
Q

The extent of absorption is very good for drugs of this permeability-solubility class.

A

I

51
Q

This solubility-permeability drug class has a high aqueous solubility and high permeability

A

Class I

52
Q

Two broad classifications for factors that affect BA (F) and BE?

A
  1. Factors that affect drug dissolution or release from dosage form
  2. Factors related to excipients that affect drug stability, absorption and metabolism
53
Q

In what ways (2) are BAs of a drug from two fmlations compared?

A
  1. Cp vs t profiles

2. AUC, Cmax, and tmax

54
Q

What is relative bioavailability?

A

Extent and rate of BA of drug from two or more diff dosage forms given by the same route of administration

55
Q

Where does most absorption take place?

A

Small intestine

PHAR 303 (13 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions