17.44 (EX) Comparing two drugs 1/3: Makers of generic drugs must show that they do not differ significantly from the “reference” drugs that they imitate. One aspect in which drugs might differ is their extent of absorption in the blood. Table 17.5 gives data taken from 20 healthy nonsmoking male subjects for one pair of drugs. This is a matched pairs design. Numbers 1 to 20 were assigned at random to the subjects. Subjects 1 to 10 received the generic drug first, and Subjects 11 to 20 received the reference drug first. In all cases, a washout period separated the two drugs so that the first had disappeared from the blood before the subject took the second. ta17-06.xls  This is a matched pairs design because each subject was evaluated on both versions of the drug. Let δ be the mean difference in absorption extent between the two versions of the drug. What is the formal hypothesis to test in comparing the two versions?   What is your conclusion? A) P-value was between 0.05 and 0.1 so there was some evidence of a difference. B) P-value > 0.5 so there was no evidence of a difference. C) P-value was between 0.1 and 0.5 so there was no evidence of a difference. D) P-value < 0.05 so there was strong evidence of a difference.

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17.44 (EX) Comparing two drugs 1/3: Makers of generic drugs must show that they do not differ significantly from the “reference” drugs that they imitate. One aspect in which drugs might differ is their extent of absorption in the blood. Table 17.5 gives data taken from 20 healthy nonsmoking male subjects for one pair of drugs. This is a matched pairs design. Numbers 1 to 20 were assigned at random to the subjects. Subjects 1 to 10 received the generic drug first, and Subjects 11 to 20 received the reference drug first. In all cases, a washout period separated the two drugs so that the first had disappeared from the blood before the subject took the second.

ta17-06.xls 

This is a matched pairs design because each subject was evaluated on both versions of the drug. Let δ be the mean difference in absorption extent between the two versions of the drug. What is the formal hypothesis to test in comparing the two versions?

 

What is your conclusion?
A) P-value was between 0.05 and 0.1 so there was some evidence of a difference.
B) P-value > 0.5 so there was no evidence of a difference.
C) P-value was between 0.1 and 0.5 so there was no evidence of a difference.
D) P-value < 0.05 so there was strong evidence of a difference.
---

**17.44 (EX) Comparing two drugs 2/3: Carry out the test. Fill in the blanks.**

\[ \bar{d} = \]  *[Fill in the blank]*  (Round to a whole number)

s =  *[Fill in the blank]*  (Round to a whole number)

df =  *[Fill in the blank]*

t =  *[Fill in the blank]*  (Round to 3 decimals)

---

This section is part of an exercise in comparing two drugs using statistical methods. The task involves computing and inputting the following:

- **\[ \bar{d} \]**: The mean difference, which needs to be rounded to a whole number.
- **s**: The standard deviation of the differences, rounded to a whole number.
- **df**: Degrees of freedom for the statistical test.
- **t**: The t-statistic, rounded to three decimal places.

Learners are expected to perform calculations and enter their answers in the provided blanks. The exercise aids in understanding statistical concepts in the context of pharmaceutical studies.
Transcribed Image Text:--- **17.44 (EX) Comparing two drugs 2/3: Carry out the test. Fill in the blanks.** \[ \bar{d} = \] *[Fill in the blank]* (Round to a whole number) s = *[Fill in the blank]* (Round to a whole number) df = *[Fill in the blank]* t = *[Fill in the blank]* (Round to 3 decimals) --- This section is part of an exercise in comparing two drugs using statistical methods. The task involves computing and inputting the following: - **\[ \bar{d} \]**: The mean difference, which needs to be rounded to a whole number. - **s**: The standard deviation of the differences, rounded to a whole number. - **df**: Degrees of freedom for the statistical test. - **t**: The t-statistic, rounded to three decimal places. Learners are expected to perform calculations and enter their answers in the provided blanks. The exercise aids in understanding statistical concepts in the context of pharmaceutical studies.
### Study Data on Reference and Generic Measurements

This table presents data from a study involving 19 subjects. Each row represents an individual subject and includes two types of measurements: "Reference" and "Generic."

- **Column A: Subject**
  - This column lists the identification numbers for each of the 19 subjects in the study.

- **Column B: Reference**
  - This column shows the measurement values obtained under a reference condition for each subject.

- **Column C: Generic**
  - This column provides the measurement values obtained under a generic condition for each corresponding subject.

#### Table Data:

- **Subject 15**: Reference = 4108, Generic = 1755
- **Subject 3**: Reference = 2526, Generic = 1138
- **Subject 9**: Reference = 2779, Generic = 1613
- **Subject 13**: Reference = 3852, Generic = 2254
- **Subject 12**: Reference = 1833, Generic = 1310
- **Subject 8**: Reference = 2463, Generic = 2120
- **Subject 18**: Reference = 2059, Generic = 1851
- **Subject 20**: Reference = 1709, Generic = 1878
- **Subject 17**: Reference = 1829, Generic = 1682
- **Subject 2**: Reference = 2594, Generic = 2613
- **Subject 4**: Reference = 2344, Generic = 2738
- **Subject 16**: Reference = 1864, Generic = 2302
- **Subject 6**: Reference = 1022, Generic = 1284
- **Subject 10**: Reference = 2256, Generic = 3052
- **Subject 5**: Reference = 938, Generic = 1287
- **Subject 7**: Reference = 1339, Generic = 1930
- **Subject 14**: Reference = 1262, Generic = 1964
- **Subject 11**: Reference = 1438, Generic = 2549
- **Subject 1**: Reference = 1735, Generic = 3340
- **Subject 19**: Reference = 1020, Generic = 3050

This
Transcribed Image Text:### Study Data on Reference and Generic Measurements This table presents data from a study involving 19 subjects. Each row represents an individual subject and includes two types of measurements: "Reference" and "Generic." - **Column A: Subject** - This column lists the identification numbers for each of the 19 subjects in the study. - **Column B: Reference** - This column shows the measurement values obtained under a reference condition for each subject. - **Column C: Generic** - This column provides the measurement values obtained under a generic condition for each corresponding subject. #### Table Data: - **Subject 15**: Reference = 4108, Generic = 1755 - **Subject 3**: Reference = 2526, Generic = 1138 - **Subject 9**: Reference = 2779, Generic = 1613 - **Subject 13**: Reference = 3852, Generic = 2254 - **Subject 12**: Reference = 1833, Generic = 1310 - **Subject 8**: Reference = 2463, Generic = 2120 - **Subject 18**: Reference = 2059, Generic = 1851 - **Subject 20**: Reference = 1709, Generic = 1878 - **Subject 17**: Reference = 1829, Generic = 1682 - **Subject 2**: Reference = 2594, Generic = 2613 - **Subject 4**: Reference = 2344, Generic = 2738 - **Subject 16**: Reference = 1864, Generic = 2302 - **Subject 6**: Reference = 1022, Generic = 1284 - **Subject 10**: Reference = 2256, Generic = 3052 - **Subject 5**: Reference = 938, Generic = 1287 - **Subject 7**: Reference = 1339, Generic = 1930 - **Subject 14**: Reference = 1262, Generic = 1964 - **Subject 11**: Reference = 1438, Generic = 2549 - **Subject 1**: Reference = 1735, Generic = 3340 - **Subject 19**: Reference = 1020, Generic = 3050 This
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