20.50 Comparing two drugs. Makers of generic drugs must con about this 20 chow 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 20.5 gives data taken from 20 healthy non- smoking male subjects for one pair of drugs." This is a matched pairs design. Numbers 1 through 20 were as- signed at random to the subjects. Subjects 1 through 10 4top 2 received the generic drug first, followed by the reference drug. Subjects 11 through 20 received the reference drug first, followed by the generic drug. 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. By randomizing the order, we eliminate the TABLE 20.5 Absorption extent for two versions of a drug Reference Generic Subject Drug Drug 15 4108 1755 2526 1138 9. 2779 1613 13 3852 2254 12 1833 1310 8 2463 2120 18 2059 1851 20 1709 1878 17 1829 1682 2594 2613 2344 2738 2302 16 1864 1284 1022 3052 10 2256 1287 938 1930 7. 1339 1964 14 1262 2549 11 1438 3340 1735 3050 19 1020 3. 2. 6

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**Exercises – Page 477**

The text discusses the potential influence of the sequence in which drugs are administered on their absorption into the bloodstream. The main question posed is whether the drugs show a significant difference in the quantity absorbed into the blood.

There is an accompanying icon representing a bar chart with the word "DRUGS" below it, suggesting a focus on comparing absorption levels of different drugs visually. However, no specific data or detailed chart is present in the image.
Transcribed Image Text:**Exercises – Page 477** The text discusses the potential influence of the sequence in which drugs are administered on their absorption into the bloodstream. The main question posed is whether the drugs show a significant difference in the quantity absorbed into the blood. There is an accompanying icon representing a bar chart with the word "DRUGS" below it, suggesting a focus on comparing absorption levels of different drugs visually. However, no specific data or detailed chart is present in the image.
**Comparing Two Drugs**

Makers of generic drugs must demonstrate that their products do not differ significantly from the "reference" drugs they imitate. A key aspect where drugs might vary is the extent of absorption into the blood. 

The text explains that Table 20.5 documents data from 20 healthy non-smoking male subjects, comparing two versions of a drug in a matched pairs design. Subjects 1 through 10 received the generic drug first, followed by the reference drug, while subjects 11 through 20 received the reference drug first, followed by the generic. A washout period was used between the consumption of the two drugs to ensure the first drug had been cleared from the bloodstream, thus negating any crossover effects. Randomization of the order helps to eliminate bias.

**Table 20.5: Absorption Extent for Two Versions of a Drug**

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

This table provides data on the absorption extent for each version
Transcribed Image Text:**Comparing Two Drugs** Makers of generic drugs must demonstrate that their products do not differ significantly from the "reference" drugs they imitate. A key aspect where drugs might vary is the extent of absorption into the blood. The text explains that Table 20.5 documents data from 20 healthy non-smoking male subjects, comparing two versions of a drug in a matched pairs design. Subjects 1 through 10 received the generic drug first, followed by the reference drug, while subjects 11 through 20 received the reference drug first, followed by the generic. A washout period was used between the consumption of the two drugs to ensure the first drug had been cleared from the bloodstream, thus negating any crossover effects. Randomization of the order helps to eliminate bias. **Table 20.5: Absorption Extent for Two Versions of a Drug** | Subject | Reference Drug | Generic Drug | |---------|----------------|--------------| | 15 | 4108 | 1755 | | 3 | 2526 | 1138 | | 9 | 2779 | 1613 | | 13 | 3852 | 2254 | | 12 | 1833 | 1310 | | 8 | 2463 | 2120 | | 18 | 2059 | 1851 | | 20 | 1709 | 1878 | | 17 | 1829 | 1682 | | 2 | 2594 | 2613 | | 4 | 2344 | 2738 | | 16 | 1864 | 2302 | | 6 | 1022 | 1284 | | 10 | 2256 | 3052 | | 5 | 938 | 1287 | | 7 | 1339 | 1930 | | 14 | 1262 | 1964 | | 11 | 1438 | 2549 | | 1 | 1735 | 3340 | | 19 | 1020 | 3050 | This table provides data on the absorption extent for each version
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