Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

On sample size calculation in bioequivalence trials.

S C Chow1, H Wang

  • 1StatPlus, Inc., 1790 Yardley-Langhorne Road, Yardley, Pennsylvania 19067, USA.

Journal of Pharmacokinetics and Pharmacodynamics
|May 31, 2001
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Duck hepatitis B virus integrations in LMH chicken hepatoma cells: identification and characterization of new episomally derived integrations.

Journal of virology·1995
Same author

Automated assay of oxygen radical absorbance capacity with the COBAS FARA II.

Clinical chemistry·1995
Same author

The Claviceps purpurea gene encoding dimethylallyltryptophan synthase, the committed step for ergot alkaloid biosynthesis.

Biochemical and biophysical research communications·1995
Same author

Direct effects of smooth muscle relaxation and contraction on in vivo human brachial artery elastic properties.

Circulation research·1995
Same author

Yeast two-hybrid system demonstrates that estrogen receptor dimerization is ligand-dependent in vivo.

The Journal of biological chemistry·1995
Same author

Synthesis, characterization and antibacterial activity of novel Fe(III), Co(II), and Zn(II) complexes with norfloxacin.

Journal of inorganic biochemistry·1995
Same journal

Optimizing Subcutaneous Antibody Dosing Regimens Through Operating Space Maps: rHuPH20 Case Study.

Journal of pharmacokinetics and pharmacodynamics·2026
Same journal

Mechanistic modeling of FcRn-dependent IgG drug interactions: Clinical applications and dosing implications.

Journal of pharmacokinetics and pharmacodynamics·2026
Same journal

Comparing heavy-tailed residual error models for outlier handling in population PK modeling.

Journal of pharmacokinetics and pharmacodynamics·2026
Same journal

Personalized prophylactic therapy optimization in hemophilia A using a hybrid PK-PD-TTE model and deep RL.

Journal of pharmacokinetics and pharmacodynamics·2026
Same journal

Pediatric oral cavity physiologically based pharmacokinetic model to predict pharmacokinetics of mucoadhesive atropine gel to treat sialorrhea.

Journal of pharmacokinetics and pharmacodynamics·2026
Same journal

Exposure-safety analyses of talazoparib in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) in the TALAPRO-2 trial.

Journal of pharmacokinetics and pharmacodynamics·2026
See all related articles

Calculating sample size for bioequivalence trials is crucial. This study details differences in sample size calculations for crossover versus parallel designs, using raw or log-transformed data.

Area of Science:

  • Pharmacokinetics and Biopharmaceutics
  • Statistical Methods in Clinical Trials

Background:

  • Sample size calculation is critical for the statistical power and reliability of bioequivalence trials.
  • Bioequivalence studies commonly employ crossover or parallel designs, utilizing either raw or log-transformed pharmacokinetic data.

Purpose of the Study:

  • To elucidate the distinctions in sample size determination between crossover and parallel designs in bioequivalence studies.
  • To provide derived formulas for sample size calculations applicable to both raw and log-transformed data under different study designs.

Main Methods:

  • Derivation of mathematical formulas for sample size calculation.
  • Comparative analysis of sample size requirements across different design and data transformation scenarios.

Related Experiment Videos

Main Results:

  • Formulas for sample size calculation were derived for both crossover and parallel designs.
  • The study highlights the impact of design choice (crossover vs. parallel) and data type (raw vs. log-transformed) on required sample sizes.

Conclusions:

  • Understanding the differences in sample size calculations is essential for efficient bioequivalence trial planning.
  • The derived formulas offer a basis for selecting appropriate sample sizes based on study design and data characteristics.