Brainscape's Knowledge GenomeTM

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


See full index

Pharmacokinetics > Exam 2 > Flashcards

Exam 2 Flashcards

1
Q

Cmax of Oral vs IV drugs

A

Oral drugs have lower Cmax than IV drugs at the same dose

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

Lag time

A

delay in absorption seen in some drugs

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

What can contribute to lag time?

A

Drug formulation

Physiologic factors such as gastric emptying time

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

How long can lag time be?

A

minutes to hours

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

Enteric coating effect on lag time?

A

increase, causes long lag times

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

Onset time

A

time required for pharmacologic effects to start

Depends on how fast plasma conc reach minimum effective conc

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

“Flip Flop”

A

occurs when absorption is inherently slow

formation is controlled release type

Elimination half-life is short

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

Flip flop will cause drug to exhibit….

A

absorption rate limited elimination

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

Flip flop is when

A

linear segment of oral curve represents absorption phase, instead of elimination

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

How to ID Flip Flop?

A

Using IV data

Using data from different dosage forms admin via the same route

Using data from different routes admin

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

When half-life for oral and IV data are very similar, then…

A

terminal oral half life is related to the elimination

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

When IV half-life is shorter than that of oral, then….

A

terminal oral half-life is related to absorption process

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

Solutions vs Tablets?

A

Solutions exhibit faster absorption and shorter half lives

Tablets show slower absorption and longer half-lives

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

Half life when drug Admin via IM and Oral route?

A

Terminal Half-lives = same

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

Absorption half-life and elimination half-life when admin via 2 different routes?

A

Absorption half-life will be different

Elimination half-life will be the same

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

How does K effect Tmax?

A

Larger K/Ka will result in shorter Tmax

inversely related

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

What’s required for new drug to be made?

A

Drug discovery, formulation, lab development, animal studies, clinical studies

IND,NDA, IRB

Long process

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What’s required for Generic drug to be made?

A

ANDA

Eval of BE studies for approval in 1984 (Waxman-Hatch Act, Drug price competition and patent term restoration act)

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

Reference Listed Drug

A

ID by FDA as th drug product on which an applications relies when seeking approval of ADNA

Usually the brand name drug that has full NDA

20
Q

Abbreviated New Drug Application

A

ANDA

must be filed and approved for generic drug

Generic manufacturer is not required to perform clinical efficacy studies or nonclinical toxicology studies

21
Q

Drug Substance

A

the active pharmaceutical ingredient

22
Q

Drug product

A

the finished pill, tab, capsule, solution etc

23
Q

Pharmaceutical Alternatives

A

Products that contain same therapeutic moiety but as different salts, esters, or complexes

Ex.

XR and IR dosage forms

24
Q

Pharmaceutical Equivalents

A

Products in identical dosage forms that contain the same active ingredients (same Salt/Ester), same dosage form, use same route of admin, and identical in strength or conc

25
Q

How can pharmaceutical equivalents differ?

A

shape, scoring configuration, release mechanisms, labeling, packaging

26
Q

Bioequivalent Drug products

A

Rate and extent of absorption do not show significant difference when admin at same molar dose of the therapeutic moiety

27
Q

Bioequivalence Requirement

A

imposed by FDA for in vitro/in vivo testing of specified drug products which must be satisfied as a condition of marketing

28
Q

Pharmaceutical Substitution

A

dispensing pharmaceutical alternative for prescribed drug product

Ex.
ampicillin suspension in place of capsules

29
Q

Generic Substitution

A

dispensing different brand or unhanded drug in place of prescribed drug product

Ex.
Ibuprofen in place of Motrin

30
Q

Therapeutic Alternatives

A

products containing different active ingredient that are indicated for the same therapeutic or clinical objectives

31
Q

Therapeutic Equivalents

A

products considers only if they’re pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when admin to patients

32
Q

2 Formulations are bioequivalent when AUC and Max are…

A

within 80 - 125% of those for reference formulation

33
Q

Orange book

A

FDA published

A = therapeutically equivalent
B = not therapeutically equivalent
34
Q

Common study in Bioequivalence study?

A

Crossover design

35
Q

3 studies required for solids dosage forms

A

Fasting study
Food interaction study
Multiple Dose study

36
Q

Bio-waivers

A

using in vitro dissolution profile instead of in-vivo bioavailability

37
Q

When are Bio-waivers used?

A

When product is same dosage form but in different strengths and is proportionally similar in active and inactive ingredients

38
Q

Bio-waiver can be granted for different strengths of a drug product when….

A
  1. The drug product is in the same dosage form, but in a different strength
  2. This different strength is proportionally similar in its active and inactive ingredients to the strength of the product for which the same manufacturer has conducted an appropriate in vivo study
  3. The new strength meets an appropriate in vitro dissolution test.
39
Q

What is a biosimilar product?

A
  1. Copy of a renege biological product that shares same primary amino acid sequence with that of reference
  2. Changing order of amino acids creates different primary structure
  3. Differences in critical quality attributes are close enough to achieve a designation of similarity following an assessment of safety and efficacy
40
Q

Biosimilars vs Generics

A

Generics = pretty much identical (2 green apples)

Biosimilars = Similar (Green vs Red apple)

41
Q

IV infusion Advantages

A
  1. Can deliver exact amount of drug into body to achieve and maintain a certain conc
  2. Unlike multiple dosing, IV infusion circumvents ups/downs of drugs plasma levels
  3. Allows co-admin of drugs with IV fluids
  4. Drug admin can be initiated and terminated as needed
42
Q

IV infusion disadvantages

A
  1. Requires hospitalization and specialized devices at home

2. Expensive and inconvenient

43
Q

What order process is IV infusion admin?

A

Zero order

44
Q

What order process is IV infusion elimination?

A

First order

45
Q

Relationship of Css, infusion-rate, and Clearance?

A

When the infusion rate is doubled, Css will be doubled.

When drug clearance decreases, Css would increase

46
Q

Time to reach Css depends on….

A

only alf-life of drugs, not on the dose

Pharmacokinetics (4 decks)

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