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Related Experiment Videos

Carry-over effects in bioequivalence studies.

G Dangelo1, D Potvin, J Turgeon

  • 1Pharmacokinetics and Pharmacodynamics, MDS Pharma Services, Saint-Laurent, Montreal, Quebec, Canada.

Journal of Biopharmaceutical Statistics
|July 19, 2001
PubMed
Summary
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Carry-over effects are infrequent in bioequivalence studies. Analysis suggests adjusting for carry-over is often unnecessary, simplifying study design and analysis for pharmacokinetic variables like Cmax and AUC0-t.

Area of Science:

  • Pharmacokinetics
  • Clinical Trial Design
  • Biostatistics

Background:

  • Carry-over effects pose challenges in crossover study designs.
  • The necessity of adjusting for carry-over in bioequivalence studies remains a key consideration.

Purpose of the Study:

  • To investigate the frequency of carry-over effects in actual bioequivalence studies.
  • To determine the impact of statistically significant carry-over effects on bioequivalence outcomes.
  • To discuss the rationale for not adjusting for carry-over in bioequivalence study analyses.

Main Methods:

  • Analysis of 96 three-period, three-treatment fed-fasted crossover studies for carry-over effects.
  • Indirect assessment of carry-over effects in 324 two-period, two-treatment fasted studies via sequence effects.

Related Experiment Videos

  • Modeling of log-transformed Cmax and AUC0-t pharmacokinetic variables using analysis of variance (ANOVA).

    • Main Results:

    • Carry-over effects were observed with a certain frequency in the analyzed bioequivalence studies.
    • Statistically significant carry-over effects can impact bioequivalence results.
    • The study provides insights into the practical occurrence of carry-over effects.

    Conclusions:

    • The findings contribute to the understanding of carry-over effects in bioequivalence trials.
    • The discussion addresses the justification for current practices regarding carry-over adjustment.
    • This research informs decisions on managing carry-over effects in pharmacokinetic study designs.