Predictive Potential of Cmax Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ2 Similarity Factor Method Article Swipe
Sara Carolina Henriques
,
Paulo Paixão
,
Luís Almeida
,
Nuno Silva
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.3390/pharmaceutics15102498
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.3390/pharmaceutics15102498
Pilot bioavailability/bioequivalence (BA/BE) studies are downsized trials that can be conducted prior to the definitive pivotal trial. In these trials, 12 to 18 subjects are usually enrolled, although, in principle, a sample size is not formally calculated. In a previous work, authors recommended the use of an alternative approach to the average bioequivalence methodology to evaluate pilot studies’ data, using the geometric mean (Gmean) ƒ2 factor with a cut off of 35, which has shown to be an appropriate method to assess the potential bioequivalence for the maximum observed concentration (Cmax) metric under the assumptions of a true Test-to-Reference Geometric Mean Ratio (GMR) of 100% and an inter-occasion variability (IOV) in the range of 10% to 45%. In this work, the authors evaluated the proposed ƒ2 factor in comparison with the standard average bioequivalence in more extreme scenarios, using a true GMR of 90% or 111% for truly bioequivalent formulations, and 80% or 125% for truly bioinequivalent formulations, in order to better derive conclusions on the potential of this analysis method. Several scenarios of pilot BA/BE crossover studies were simulated through population pharmacokinetic modelling, accounting for different IOV levels. A redefined decision tree is proposed, suggesting a fixed sample size of 20 subjects for pilot studies in the case of intra-subject coefficient of variation (ISCV%) > 20% or unknown variability, and suggesting the assessment of study results through the average bioequivalence analysis, and additionally through Gmean ƒ2 factor method in the case of the 90% confidence interval (CI) for GMR is outside the regulatory acceptance bioequivalence interval of [80.00–125.00]%. Using this alternative approach, the certainty levels to proceed with pivotal studies, depending on Gmean ƒ2 values and variability scenarios tested (20–60% IOV), were assessed, which is expected to be helpful in terms of the decision to proceed with pivotal bioequivalence studies.
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.3390/pharmaceutics15102498
- https://www.mdpi.com/1999-4923/15/10/2498/pdf?version=1697786568
- OA Status
- gold
- Cited By
- 1
- References
- 9
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4387813049
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Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4387813049Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.3390/pharmaceutics15102498Digital Object Identifier
- Title
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Predictive Potential of Cmax Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ2 Similarity Factor MethodWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
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2023-10-20Full publication date if available
- Authors
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Sara Carolina Henriques, Paulo Paixão, Luís Almeida, Nuno SilvaList of authors in order
- Landing page
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https://doi.org/10.3390/pharmaceutics15102498Publisher landing page
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https://www.mdpi.com/1999-4923/15/10/2498/pdf?version=1697786568Direct link to full text PDF
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://www.mdpi.com/1999-4923/15/10/2498/pdf?version=1697786568Direct OA link when available
- Concepts
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Bioequivalence, Cmax, Confidence interval, Statistics, Geometric mean, Mathematics, Bioavailability, Sample size determination, Crossover study, Medicine, Econometrics, Pharmacology, Placebo, Pathology, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
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1Total citation count in OpenAlex
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2024: 1Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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