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

Probability lower bounds for USP/NF tests.

Shein-Chung Chow1, Jun Shao, Hansheng Wang

  • 1StatPlus Inc., Yardley, PA 19067, USA.

Journal of Biopharmaceutical Statistics
|July 31, 2002
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

Delphinidin targets voltage-dependent anion channel 1 to inhibit ferroptosis and protect against retinal photochemical damage.

Phytomedicine : international journal of phytotherapy and phytopharmacology·2026
Same author

Genome-wide analysis of the <i>GID</i> gene family in soybean and analysis of expression under gibberellin treatment.

Frontiers in plant science·2026
Same author

Decentralized EM algorithm for Gaussian mixtures under data heterogeneity and partial labeling.

Biometrics·2026
Same author

Efficacy and safety of ultrasound-guided microwave ablation for primary hyperparathyroidism: a dual-centre study.

Scientific reports·2026
Same author

Multiscale multimodal graph convolutional networks for identifying essential tremor and dystonic tremor.

Neurobiology of disease·2026
Same author

Correction: RBX1 regulates PKM alternative splicing to facilitate anaplastic thyroid carcinoma metastasis and aerobic glycolysis by destroying the SMAR1/HDAC6 complex.

Cell & bioscience·2026
Same journal

Correction.

Journal of biopharmaceutical statistics·2026
Same journal

Leveraging external controls in clinical trials: estimands, estimation, assumptions.

Journal of biopharmaceutical statistics·2026
Same journal

Special issue of nonclinical statistics in regulatory applications guest editors' notes.

Journal of biopharmaceutical statistics·2026
Same journal

Comparison of flexible parametric modeling and nonparametric methods to estimate restricted mean survival time: A simulation study.

Journal of biopharmaceutical statistics·2026
Same journal

Simulated treatment comparisons with jackknife pseudo values for estimating population-adjusted marginal treatment effects.

Journal of biopharmaceutical statistics·2026
Same journal

Sample sizes for randomized controlled trials utilizing Bayesian response adaptive randomization for continuous outcomes.

Journal of biopharmaceutical statistics·2026
See all related articles

This study derives improved probability lower bounds for United States Pharmacopedia and National Formulary (USP/NF) tests. These new bounds enhance the likelihood of pharmaceutical products meeting quality standards during manufacturing.

Area of Science:

  • Pharmaceutical Manufacturing
  • Quality Control
  • Statistical Analysis

Background:

  • Pharmaceutical products undergo rigorous testing like content uniformity and dissolution to meet United States Pharmacopedia and National Formulary (USP/NF) standards.
  • Ensuring drug product quality requires adherence to USP/NF sampling plans, testing procedures, and acceptance criteria.

Purpose of the Study:

  • To derive novel probability lower bounds for USP/NF tests.
  • To improve the accuracy of in-house specification limits used by pharmaceutical manufacturers.
  • To increase the probability of successfully passing USP/NF tests for drug products.

Main Methods:

  • Development of new statistical methods for calculating probability lower bounds.
  • Comparative analysis of proposed bounds against existing methods.

Related Experiment Videos

  • Validation across a wide range of population mean and variance for test samples.

    • Main Results:

    • The derived probability lower bounds are demonstrated to be superior to current industry standards.
    • The proposed bounds show high accuracy, closely approximating true probabilities.
    • Effectiveness is validated across diverse population parameters for test samples.

    Conclusions:

    • The new probability lower bounds offer a more reliable approach for setting in-house specifications.
    • Implementation can lead to a higher success rate in meeting USP/NF quality requirements.
    • This research contributes to enhanced pharmaceutical quality control and manufacturing efficiency.