Makers of generic drugs must show that they do not differ significantly from the "reference" drugs...

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. The table 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 drug. Absorption extent for two versions of a drug Subject Reference Generic Subject Reference Generic 15 4108 1755 4 2344 2738 3 2526 1138 16 1864 2302 9 2779 1613 6 1022 1284 13 3852 2254 10 2256 3056 12 1833 1310 5 938 1287 8 2463 2120 7 1339 1930 18 2059 1851 14 1262 1964 20 1709 1878 11 1438 2549 17 1829 1682 1 1735 3340 2 2594 2613 19 1020 3050 To access the complete data set, click the link for your preferred software format: Excel Minitab JMP SPSS TI R Mac-TXT PC-TXT CSV CrunchIt!

Do the drugs differ significantly in absorption?

STATE: Do the generic and reference drugs differ in mean absorption level? PLAN: We test H 0 : μ = 0 versus H a : μ ≠ 0 , where μ is the mean difference in absorption (Generic minus Reference). The alternative is two‑sided because we have no prior expectation of a direction for the difference. SOLVE: Find ¯ x , s , and the t statistic. (Enter your answers rounded to two decimal places.) ¯ x = s = t = Find the degrees of freedom. (Enter your answer as a whole number.) df = Obtain the P ‑value. (Enter your answer rounded to two decimal places.) P ‑value = CONCLUDE: Do the drugs differ significantly in absorption? No, the drugs don't differ significantly in absorption ( 0.05 < P < 0.1 ) . Yes, the drugs differ significantly in absorption ( P < 0.01 ) . Yes, the drugs differ significantly in absorption ( 0.01 < P < 0.05 ) . No, the drugs don't differ significantly in absorption ( P > 0.5 ) .

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orchestra answered 1 year ago

Makers of generic drugs must show that they do not differ significantly from “reference” drugs that...

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