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

Sample size and power analysis for endometrial safety studies.

Guoqin Su1

  • 1Novartis Pharmaceuticals, One Health Plaza, East Hanover, NJ 07936, USA. guoqin.su@novartis.com

Journal of Biopharmaceutical Statistics
|June 1, 2005
PubMed
Summary

This study determined optimal sample sizes for endometrial safety studies of progestin components, ensuring compliance with both European and US regulatory standards. Findings reveal that increased sample size does not invariably enhance statistical power, highlighting the need for careful study design.

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

Pharmacokinetics, safety and efficacy of an optimized dose of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in neonates and infants of less than 5 kg body weight: a multicentre, open-label, single-arm phase 2/3 study (CALINA).

Tropical medicine and health·2025
Same author

Pharmacokinetics of Ganaplacide and Lumefantrine in Adults, Adolescents, and Children with Plasmodium falciparum Malaria Treated with Ganaplacide Plus Lumefantrine Solid Dispersion Formulation: Analysis of Data from a Multinational Phase 2 Study.

Journal of clinical pharmacology·2024
Same author

Estimated distribution of malaria cases among children in sub-Saharan Africa by specified age categories using data from the Global Burden of Diseases 2019.

Malaria journal·2023
Same author

Prescription patterns and compliance with World Health Organization recommendations for the management of uncomplicated and severe malaria: A prospective, real-world study in sub-Saharan Africa.

Malaria journal·2023
Same author

Ganaplacide (KAF156) plus lumefantrine solid dispersion formulation combination for uncomplicated Plasmodium falciparum malaria: an open-label, multicentre, parallel-group, randomised, controlled, phase 2 trial.

The Lancet. Infectious diseases·2023
Same author

Hepatic safety and tolerability of cipargamin (KAE609), in adult patients with Plasmodium falciparum malaria: a randomized, phase II, controlled, dose-escalation trial in sub-Saharan Africa.

Malaria journal·2021

Area of Science:

  • Pharmacometrics
  • Clinical Trial Design
  • Regulatory Science

Background:

  • Endometrial safety is a critical endpoint for progestin component approval.
  • Regulatory bodies like the CPMP and FDA have specific statistical criteria for these studies.

Purpose of the Study:

  • To evaluate sample size and statistical power requirements for meeting dual regulatory standards (CPMP and FDA) for endometrial safety.
  • To identify an optimal sample size that satisfies both regulatory criteria.

Main Methods:

  • Utilized exact confidence intervals for binomial and Poisson parameters to assess statistical power.
  • Analyzed the relationship between sample size and statistical power under different regulatory constraints.

Main Results:

Related Experiment Videos

  • A larger sample size does not consistently result in increased statistical power.
  • Identified a specific sample size that effectively meets both the CPMP and FDA endometrial safety requirements.

Conclusions:

  • Careful consideration of sample size is crucial for successful progestin component approval.
  • Close monitoring of patient enrollment during clinical trials is recommended to ensure study objectives are met.