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

Test for batch-to-batch variation in stability analysis.

S C Chow1, J Shao

  • 1Biometrics Department, Parke-Davis Pharmaceutical Research Division, Warner-Lambert Co., Ann Arbor, MI 48105.

Statistics in Medicine
|July 1, 1989
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

Phase II randomised study of magrolimab combined with bevacizumab-FOLFIRI in patients with previously treated advanced inoperable metastatic colorectal cancer.

ESMO gastrointestinal oncology·2026
Same author

[Impact of father involvement in childcare on maternal parenting stress for children aged 6 to 24 months in rural areas of Zhejiang Province].

Zhonghua er ke za zhi = Chinese journal of pediatrics·2026
Same author

[Safety study of navigation-assisted medial "in-out-in" technique in C<sub>2</sub> screw fixation].

Zhonghua wai ke za zhi [Chinese journal of surgery]·2025
Same author

[The clinical effect of three dimensional print guided F/B-TEVAR vascular endoluminal repair of anastomotic leaks after open surgery for type A aortic dissection].

Zhonghua wai ke za zhi [Chinese journal of surgery]·2025
Same author

[Prevalence of sarcopenia and influencing factors in middle-aged and older adults in Zhejiang Province].

Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi·2025
Same author

[Development of a grading diagnostic model for schistosomiasis-induced liver fibrosis based on radiomics and clinical laboratory indicators].

Zhongguo xue xi chong bing fang zhi za zhi = Chinese journal of schistosomiasis control·2024
Same journal

Interpretable Bayesian Modeling for Multireader Multicase Studies: Addressing Overdispersion and Limited Sample Size in Diagnostic Enhancement Evaluation.

Statistics in medicine·2026
Same journal

Adaptive Sequential Multiple Hypotheses Testing for Concomitant Vaccine Safety Surveillance.

Statistics in medicine·2026
Same journal

Novel Distance Regression for Repeated Outcomes With Missing Data: Applications to Longitudinal and Crossover Studies of Microbiome Beta-Diversity.

Statistics in medicine·2026
Same journal

Optimal Weighted Tests for Replication Studies and the 'Two-Trials Rule' With Multiple Hypotheses.

Statistics in medicine·2026
Same journal

Identifiable Copula-Double-Cox Models: A Fully Parametric Framework for Dependent Right-Censored Survival Data.

Statistics in medicine·2026
Same journal

Moving From Individualized Risk-Based Prevention to Benefit-Based Prevention: Estimating Individualized Life-Years Gained From Prevention Services as a Basis for Eligibility.

Statistics in medicine·2026
See all related articles

Statistical tests were developed to detect batch-to-batch variation in drug product stability. These methods were applied to real-world data from drug application stability studies.

Area of Science:

  • Pharmaceutical Sciences
  • Statistics
  • Drug Development

Background:

  • Ensuring drug product quality and consistency over time is critical.
  • Batch-to-batch variability can impact drug efficacy and safety.
  • Standard stability analyses may not adequately capture all sources of variation.

Purpose of the Study:

  • To introduce novel statistical tests for identifying batch-to-batch variation in drug product stability.
  • To demonstrate the practical application of these tests using authentic stability data.

Main Methods:

  • Development of several statistical hypothesis tests tailored for stability data.
  • Application of these tests to datasets from New Drug Application (NDA) stability programs.
  • Analysis of data from post-approval marketing stability studies.

Related Experiment Videos

Main Results:

  • The proposed statistical tests effectively identified significant batch-to-batch variations in multiple stability analyses.
  • The tests provided quantitative measures of variability, aiding in risk assessment.
  • Application to NDA and marketing stability data highlighted the utility in different regulatory contexts.

Conclusions:

  • The developed statistical tests are valuable tools for assessing drug product batch consistency.
  • These methods enhance the rigor of stability analysis, supporting product quality assurance.
  • Implementation can lead to more robust drug manufacturing and quality control strategies.