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Pharm 2 > test 3 > Flashcards

test 3 Flashcards

1
Q

Bioavailability

A

Rate and extent to which the active ingredient is absorbed from drug product and becomes available at the site of action

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2
Q

What is bioavailability influenced by?

A

Method of manufacture
Particle size
Crystal form
Properties of excipients
Physical changes as drug products age

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3
Q

What do BA studies used to compare?

A

Different dosage forms via different routes (which one has the most desirable absorption pattern)

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4
Q

What are BA studies used to estimate?

A

Administration dose that gets into circulation
The effect of food on the drug
Distribution and elimination characteristics
Performance of the formulation

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5
Q

Bioequivalence

A

Absence of bioavailability difference between the test drug and reference drug

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6
Q

What is plasma concentration used for in be testing?

A

It is considered a surrogate for the concentration of the drug at the site of action

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7
Q

What are BE studies used for?

A

To compare the BAs of different formulations, drug products or batches of the same drug

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8
Q

How do you find the relative bioavailability?

A

Dose of ref product x AUC of test drug after oral admin/ Dose of test drug x AUC of reference drug after oral dose

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9
Q

What is relative bioavailability used to see?

A

Drug drug interactions
Food effects
How new formulations impact bioavailability

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10
Q

What are cross over design studies used for?

A

For determination of therapeutic equivalence between generic and reference drug

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11
Q

What does AUC represent?

A

The total amount of drug absorbed into circulation
Compare total exposure or extent of drug absorption

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12
Q

How do you find absolute bioavailability?

A

IV dose x AUC after oral dose/
Oral dose x AUC after IV dose

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13
Q

What are therapeutic equivalents?

A

Drug products that are pharmaceutical equivalents with the same clinical effect and safety profile for which bioequivalence has been demonstrated

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14
Q

What are pharmaceutical equivalents?

A

Drug products that have identical dose of identical API with the same esters or salt forms and identical dosage forms

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15
Q

What are pharamaceutical alternatives?

A

Identical API or precursor that do not have the same amount, dosage forms, or salt or ester

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16
Q

What is class one of BCS classes?

A

High solubility and high permeability

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17
Q

What is class 2 of BCS?

A

Low solubility and high permeability

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18
Q

What is class 3 of BCS?

A

High solubility and low permeability

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19
Q

What is class 4 of BCS?

A

Low solubility and low permeability?

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20
Q

What classes do not require BABE studies?

A

Class 1 and 3 (high permeability)

21
Q

What is the Orange Book?

A

A book of approved drug products with therapeutic equivalence evaluations

22
Q

According to the Arrhenius equation, what happens when temperature increases?

A

The rate of the reaction does as well

23
Q

What is shelf life?

A

Time interval that a drug product is expected to remain within the approved shelf life under specific conditions (90% of the drug left)

24
Q

What is shelf life used for?

A

Used to determine expiration date of drug products

25
Q

What are the different methods to determine shelf life?

A

Direct Methods
Predictive Models Development
Accelerated shelf life studies

26
Q

What is the direct method to determine shelf life?

A

Storing product under specific conditions for a longer period of time and seeing when it begins to degrade

27
Q

What is the predictive models development?

A

Uses data from a database to calculate shelf life

28
Q

What is the accelerated shelf life studies?

A

Study it for 6 months
Deliberately increase the rate of degredation by increasing the temperature and humidity

29
Q

How do you find the shelf life from changing the temperature?

A

Original shelf life/
Q10^(T2-T1)/10

30
Q

What is Q10?

A

Temperature coefficient
Factor by which the rate of drug degradation increases when the temp is raised by 10 degrees celcius

31
Q

What does Q10 allow for?

A

Allows for the prediction of a drug products shelf life under real life conditions

32
Q

When do you use the linear traqezoidal method?

A

when plasma concentration is increasing (absorption)

33
Q

When do you use the log trapezoidal method?

A

When plasma concentration is decreasing (elimination phase)

34
Q

What does the one compartment model assume?

A

That the body is a single uniform compartment
Instantaneous dose
Rapid distribution
Drug elimination starts immediately upon admin

35
Q

What is the well stirred model?

A

Uniform and instantaneous distribution model

36
Q

What is the volume of distribution?

A

Not an actual volume just a theoretical volume in which drug distributes throughout the body

37
Q

How do you get K?

A

elimination rate/amount in body

38
Q

How do you get Co?

A

Dose/ Vd

39
Q

What is k?

A

The elimination rate constant

40
Q

What does k tell us?

A

The proportion of the rate of drug elimination and the amount of drug in the body at any given time

41
Q

What does the 1 com model predict?

A

Predicts concentration in plasma not the tissues (plasma concentration should be eliminated at the same rate as tissue)

42
Q

How do you get half life?

A

0.693/k

43
Q

How do you get k from slope?

A

lny2-lny1/t2-t1

44
Q

How do you get clearance?

A

Vdk

45
Q

What is clearance?

A

Volume of plasma fluid cleared of drug per unit of time.

46
Q

What is Pk?

A

Study of dependence of physiological process and response of the drug

47
Q

What is drug stability?

A

The time dependent degradation of a drug product

48
Q

Why do we use straight lines for relationships?

A

To interpret the data and create rates

Pharm 2 (7 decks)

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