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A method for the evaluation of individual bioequivalence
1University of Toronto, Department of Pharmacology, Ontario, Canada.
International Journal of Clinical Pharmacology and Therapeutics
|September 1, 1994
Summary
A new method evaluates individual bioequivalence by comparing drug variation within and between formulations. This approach, using crossover trials, identifies inequivalence when between-formulation variation exceeds within-formulation variation.
Area of Science:
- Pharmacokinetics and Drug Development
- Biostatistics
- Clinical Trial Design
Background:
- Assessing bioequivalence is crucial for drug product approval.
- Traditional methods focus on average bioequivalence, not individual variability.
- Individual bioequivalence is essential for ensuring consistent drug response in patients.
Purpose of the Study:
- To present a simple and effective method for evaluating individual bioequivalence.
- To establish criteria for determining drug inequivalence based on intraindividual variation.
- To propose a statistical approach for assessing individual bioequivalence in crossover trials.
Main Methods:
- Utilizing 3- or 4-period crossover trials with replicate drug administrations.
- Estimating the ratio of intraindividual variances between and within formulations.
- Applying a one-sided confidence limit criterion (Fcr) for assessing individual bioequivalence.
- Recommending graphical exploratory analysis of trial data.
Main Results:
- The proposed method identifies inequivalence if between-formulation variation exceeds within-formulation variation.
- A 90% confidence level and Fcr = 4.0 are suggested for initial evaluations.
- The method was demonstrated using olsalazine tablets and capsules, assessing both individual and average bioequivalence.
Conclusions:
- The presented method offers a straightforward evaluation of individual bioequivalence.
- This approach enhances the assessment of drug product performance at the individual patient level.
- The methodology is applicable to various drug formulations and clinical trial designs.
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