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The multivariate assessment of bioequivalence
1Center for Biostatistics and Epidemiology, College of Medicine, The Pennsylvania State University, Hershey, Pennsylvania 17033, USA.
Journal of Biopharmaceutical Statistics
|March 1, 1997
Summary
This study introduces a novel method for bioequivalence trials, comparing blood concentration profiles between test and reference drugs. The approach assesses bioequivalence by analyzing regions derived from reference and test profiles, offering a direct comparison method.
Area of Science:
- Pharmacokinetics
- Biostatistics
- Drug development
Background:
- Bioequivalence trials are crucial for generic drug approval.
- Crossover designs are commonly used in bioequivalence studies.
- Direct comparison of concentration-time profiles is needed.
Purpose of the Study:
- To propose a direct comparison method for reference and test blood concentration-time profiles in crossover bioequivalence trials.
- To develop a method robust to lower limits of detection in assays.
- To investigate population and individual bioequivalence.
Main Methods:
- Construction of an acceptable region based on the reference profile.
- Construction of a reflected region based on the test profile.
- Calculation of area ratios between these regions for each subject.
- Computation of upper confidence limits using lognormality assumption or bootstrapping.
Main Results:
- A ratio of areas is constructed for each subject to assess bioequivalence.
- The method accounts for assays with lower limits of detection.
- Confidence limits are calculated to investigate population and/or individual bioequivalence.
Conclusions:
- The proposed approach offers a direct method for comparing test and reference profiles in bioequivalence studies.
- The method is adaptable for assays with lower detection limits.
- It provides a framework for assessing both population and individual bioequivalence.