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

Multipoint dissolution specification and acceptance sampling rule based on profile modeling and principal component

Y Tsong1, T Hammerstrom, J J Chen

  • 1Division of Biometrics, Food and Drug Administration, Rockville, Maryland 20857, USA.

Journal of Biopharmaceutical Statistics
|July 1, 1997
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

Changes in phagocytosis and expression of microglial cells in craniocerebral injury mice models.

Journal of biological regulators and homeostatic agents·2016
Same author

MRI differential diagnosis of suspected multiple sclerosis.

Clinical radiology·2016
Same author

Interactions between head motion and coil sensitivity in accelerated fMRI.

Journal of neuroscience methods·2016
Same author

Downregulation of YAP-dependent Nupr1 promotes tumor-repopulating cell growth in soft matrices.

Oncogenesis·2016
Same author

Identification and expression analysis of the sting gene, a sensor of viral DNA, in common carp Cyprinus carpio.

Journal of fish biology·2016
Same author

Changes and clinical significance of serum vaspin levels in patients with type 2 diabetes.

Genetics and molecular research : GMR·2015

New methods simplify dissolution testing specifications for pharmaceutical quality control. These approaches reduce complexity for products requiring controlled dissolution profiles over time, improving batch release efficiency.

Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Quality Control

Background:

  • Dissolution testing is crucial for pharmaceutical quality control, requiring multiple measurements over time to ensure product compliance.
  • Existing multivariate confidence region methods can be complex for dissolution profiles with many time points.

Purpose of the Study:

  • To propose two alternative, dimension-reduced procedures for setting dissolution specifications.
  • To simplify the acceptance rule for dissolution testing batches.

Main Methods:

  • Modeling approach: Develop specifications based on the confidence region of physical curve parameters describing the dissolution profile.
  • Principal Component (PC) approach: Identify principal components (linear combinations of measurements) and set specifications based on their confidence intervals.

Related Experiment Videos

  • Single-stage acceptance rule: Project new batch data onto determined axes and assess the proportion of out-of-specification tablets.

    • Main Results:

    • Both proposed methods reduce the dimensionality compared to the general multivariate confidence region approach.
    • The single-stage acceptance rule streamlines the batch release process.
    • Specifications can be set more efficiently for dissolution profiles with over 4 time points.

    Conclusions:

    • The modeling and PC approaches offer practical alternatives for establishing dissolution specifications.
    • These methods enhance the efficiency and simplicity of quality control for pharmaceutical products with complex dissolution profiles.