Reference tables for the intrasubject coefficient of variation in bioequivalence studies

Area of Science:

• Pharmacokinetics
• Drug Development
• Biostatistics

Background:

• Bioequivalence studies are essential for generic drug approval.
• Crossover study designs are standard for bioequivalence assessments.
• Intrasubject variability is a key parameter for sample size determination in these studies.

Purpose of the Study:

• To provide reference values for the intrasubject coefficient of variation (CV) for various drugs.
• To facilitate accurate sample size planning in bioequivalence studies.
• To address the common lack of accessible intrasubject CV data in published literature.

Main Methods:

• Compilation of intrasubject CV data from previously published bioequivalence studies.
• Inclusion of pharmacokinetic characteristics for different drug formulations (immediate- and extended-release).
• Analysis of data from both single- and multiple-dose crossover study designs.

Main Results:

• Presentation of reference values for intrasubject CV for a range of drugs.
• Detailed pharmacokinetic profiles associated with these variations.
• Data categorized by formulation type and dosing regimen.

Conclusions:

• The provided reference values can aid researchers in planning bioequivalence studies.
• Accessible intrasubject CV data improves the efficiency and reliability of sample size calculations.
• This resource supports the development and approval of generic medications.