Bioequivalence (2) [Uncomplicated Drugs] Flashcards Preview

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Flashcards in Bioequivalence (2) [Uncomplicated Drugs] Deck (29)
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1
Q

For Average BE studies, what is the minimum percentage difference b/w the test and reference drugs?

A

+/- 20%

2
Q

For Average BE studies, what’s the sig. level?

A

0.05

3
Q

For Average BE studies, what’s the power of the test set to?

A

0.8 (prob of detecting a diff if it truly exists b/w Test and Ref drugs)

4
Q

For Average BE studies, what’s the typical sample size range?

A

24-36

5
Q

For Average BE studies, do we typically use healthy or sick volunteers?

A

Healthy

6
Q

In PK-BE studies, how many t1/2’s do we sample for?

A

at least 3 half lives

7
Q

In PK-BE studies, when do we want to take more frequent blood samples from pts?

A

Around Cmax

8
Q

In PK-BE studies, when assessing our data, what important PK parameters do we want to calculate? (3)

A

AUC, Cmax, Tmax

9
Q

For BE to be established, drugs must be equivalent wrt ___ and ____ of drug absorption

A

rate, extent

10
Q

What does Cmax represent?

A

peak exposure

11
Q

What does AUC represent?

A

total exposure

12
Q

In the past, how was BE established?

A

Mean AUC or Cmax of test drug was within +/- 20% of that of reference drug

13
Q

What approach is used today to determine BE?

A

Confidence Interval approach

14
Q

What is the ratio of means of the T and R drugs in a 90% confidence interval?

A

0.80-1.20

15
Q

What is the ratio of means of the T and R drugs in a 90% confidence interval when the data are log transformed?

A

0.80-1.25

16
Q

Why Log transform BE metrics (AUC, Cmax, Cp vs t)?

A

It makes the data normally distributed

17
Q

T or F: Most PK parameters yield normal distributions

A

F

Mostly skewed dists

18
Q

3 approaches to BE comparisons?

A
  1. Average BE
  2. Population BE
  3. Individual BE
19
Q

T or F: Individual BE is the simplest approach to BE comparisons.

A

F

Average BE is the simplest approach

20
Q

What’re the two types of study design?

A
  1. Crossover

2. Parallel

21
Q

When is a parallel group design utilized?

A

When…

  1. drug causes physiological change that persists to the next treatment arm
  2. drug has long t1/2
  3. drug shows flip-flop kinetics
22
Q

Does crossover or parallel study design allow examination of intrasubject variation?

A

Crossover

23
Q

Which study design is preferred - crossover or parallel?

A

Crossover

24
Q

Most common single oral dose design?

A

2-product, 2-period, 2-sequence, crossover

25
Q

The Cmax value is used to evaluate ___ of absorption

A

rate

26
Q

The AUC value is used to evaluate ___ of absorption

A

extent

27
Q

When is BE of uncomplicated drugs concluded via the confidence interval approach?

A

When the 90% confidence intervals of both Cmax’s and AUC’s geometric mean ratios of the two fmlations fall within the BE range of 80-125%.

28
Q

Which is worse: 90% Confidence Interval failing for AUC or Cmax?

A

AUC

29
Q

Are t tests one sided or two sided for BE studies?

A

One-sided w/ 95% Confidence