Confidence Interval Criteria for Assessment of Dose Proportionality

• Published in: Pharmaceutical research Vol. 17; no. 10; pp. 1278 - 1283
• Main Authors: Smith, Brian P., Vandenhende, Francois R., DeSante, Karl A., Farid, Nagy A., Welch, Pamela A., Callaghan, John T., Forgue, S. Thomas
• Format: Journal Article
• Language: English
• Published: New York, NY Springer 01.10.2000; Springer Nature B.V
• Subjects: Analysis of Variance; Bioequivalence; Biological and medical sciences; Confidence Intervals; Dose-Response Relationship, Drug; Drug dosages; Expected values; General pharmacology; Hypotheses; Hypothesis testing; Linear Models; Mathematical Computing; Medical sciences; Models, Biological; Pharmacokinetics; Pharmacokinetics. Pharmacogenetics. Drug-receptor interactions; Pharmacology. Drug treatments; Therapeutic Equivalency; Variance analysis; Increasing dose; Absorption; Bioequivalence; Estimation; Elimination; Mathematical model; Pharmacokinetics; Dose; Confidence interval

The aim of this work was a pragmatic, statistically sound and clinically relevant approach to dose-proportionality analyses that is compatible with common study designs. Statistical estimation is used to derive a (1-alpha)% confidence interval (CI) for the ratio of dose-normalized, geometric mean va...