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Measuring switchability and prescribability: when is average bioequivalence sufficient?

W W Hauck¹, S Anderson

¹Biostatistics Section, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA.

Journal of Pharmacokinetics and Biopharmaceutics

|December 1, 1994

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Ensuring switchability in generic drug bioequivalence testing is crucial. New measures assess when average bioequivalence is insufficient, necessitating individual or population bioequivalence assessments for patient safety.

Area of Science:

Pharmacokinetics and Drug Metabolism
Biostatistics and Clinical Trial Design
Pharmaceutical Sciences

Background:

Current bioequivalence (BE) testing for generic drugs primarily focuses on average bioequivalence.
While switchability is generally accepted as necessary for generic drug approval, there's resistance to changing statistical procedures and study designs.
Prescribability may suffice in some BE testing contexts, but not for ensuring patients can switch medications safely.

Purpose of the Study:

To propose novel, easily interpretable measures for assessing switchability and prescribability in bioequivalence testing.
To identify conditions where average bioequivalence is inadequate for ensuring switchability and prescribability.
To establish criteria for when individual or population bioequivalence procedures are required.

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Main Methods:

Development of new statistical measures for switchability and prescribability.
Analysis of conditions under which current average bioequivalence criteria fall short.
Exploration of the relationship between proposed measures and existing individual bioequivalence assessment approaches.

Main Results:

Proposed measures provide a basis for evaluating switchability and prescribability.
Identified specific conditions where average bioequivalence is insufficient.
Demonstrated that current practices may not always guarantee safe medication switching.
Established a link between current methods for assessing individual bioequivalence.

Conclusions:

Average bioequivalence alone is not always sufficient to ensure drug switchability and prescribability.
New measures are needed to assess conditions requiring individual or population bioequivalence.
Current bioequivalence testing practices may require revision to ensure patient safety and therapeutic efficacy.
The findings connect different approaches to assessing individual bioequivalence.