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Information on statistical analysis of pharmaceutical formulations, focusing on comparing bioavailabilities of two drugs using parallel groups design and calculating confidence intervals for population mean differences. It also covers odds ratios, relative risks, and hypothesis testing in the context of pharmaceutical studies.

Typology: Exams

Pre 2010

1 / 5

Download Comparing Bioavailabilities & Confidence Intervals in Pharma Formulations and more Exams Statistics in PDF only on Docsity! STA 4170 — Exam 2 — Fall 2000 — Print Name: I have not cheated in any way, shape, or form — Sign here: The following 3 questions are based on the following information A pharmaceutical firm wishes to compare the bioavalabilities of two formulations of a drug. They take a sample of n = 18 adults, and have each subject take each formulation. The area under the concentration vs time curve (AUC) is obtained for each subject on each drug. The difference between formulations A and B is obtained for each subject. 1) This is an example of a: a) Parallel groups design/Observational study b) Parallel groups design/Controlled experiment c) Crossover design/Observational study d) Crossover design/Controlled experiment 2) The mean and standard deviation of the differences are 50.0 and 125.0, respectively. Give a 95% confidence interval for the population mean difference. a) (−213.8, 313.8) b) (−12.2, 112.2) c) (12.2, 112.2) d) (35.3, 64.7) 3) Regardless of your answer to the previous problem, suppose a researcher reports that a 95% confidence interval for the population mean difference is (20.0,80.0). Which statement is most appropriate at the α = 0.05 significance level? a) Conclude that mean AUC is higher for formulation A b) Conclude that mean AUC is higher for formulation B c) Do not conclude that mean AUC differs between the two formulations 4) A case–control study was conducted, where 500 patients with disease X were matched with 500 patients without disease X (controls). Among the disease X patients, 200 had taken a particular OTC medication. Among the controls, 50 had taken the OTC medication. Give the estimated odds ratio: odds of exposure to OTC drug|disease X present odds of exposure to OTC drug|disease X absent a) 2.0 b) 4.0 c) 2/3 d) 6.0 5) A cohort study is conducted, following a group of adults taking a diet medication and a similar control group of adults not on the medication. The outcome of interest was whether or a person develops a particular heart condition within five years of beginning teatment. The following table gives the study results. Obtain the estimated relative risk of heart condition for the diet group relative to the control group. Heart Condition Group Yes No Total Diet 40 960 1000 Control 30 970 1000 Total 70 1930 2000 a) 1.33 b) 1.15 c) 0.75 d) 2.45 The following 2 questions are based on the following information A study comparing adverse reactions to 3 brands of OTC pain killer led to the following counts of patients with and without adverse reactions (AR). Drug AR No AR Total A 40 160 200 B 60 140 200 C 110 90 200 Total 210 390 600 6) Under the null hypothesis of no association between the drug and the onset of adverse reaction, how many patients would you expect to have reported adverse reactions on drug A (exp11)? What would be the contribution to the χ2 statistic (X211). a) exp11 = 40, X211 = 0 b) exp11 = 60, X211 = 6.7 c) exp11 = 70, X211 = 22.5 d) exp11 = 70, X 2 11 = 12.9 7) What would the rejection region for this test (at α = 0.05 significance level)? a) RR : X2obs ≥ 5.991 b) RR : X2obs ≤ 5.991 c) RR : X2obs ≥ 12.592 d) RR : X2obs ≤ 12.592