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

Practical pharmacovigilance analysis strategies.

A Lawrence Gould1

  • 1Merck Research Laboratories, BL3-2 West Point, PA 19486, USA. goulda@merck.com

Pharmacoepidemiology and Drug Safety
|October 16, 2003
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

A framework for assessing the impact of accelerated approval.

PloS one·2022
Same author

Bayesian screening for feature selection.

Journal of biopharmaceutical statistics·2022
Same author

BMA-Mod: A Bayesian model averaging strategy for determining dose-response relationships in the presence of model uncertainty.

Biometrical journal. Biometrische Zeitschrift·2018
Same author

Principled Structured Incorporation of Clinical Knowledge Into Strategic Development Decisions.

Therapeutic innovation & regulatory science·2018
Same author

Methods and Issues to Consider for Detection of Safety Signals From Spontaneous Reporting Databases: A Report of the DIA Bayesian Safety Signal Detection Working Group.

Therapeutic innovation & regulatory science·2018
Same author

Unified screening for potential elevated adverse event risk and other associations.

Statistics in medicine·2018
Same journal

A Drug-Environment Interaction Between PM<sub>2</sub> <sub>.5</sub> Concentration and Corticosteroid Use on Cardiovascular and Thromboembolic Events in Older Adults.

Pharmacoepidemiology and drug safety·2026
Same journal

Association Between Socioeconomic Conditions and Biologic Prescriptions for Inflammatory Bowel Diseases in the Brazilian Public Healthcare System: An Ecological Study.

Pharmacoepidemiology and drug safety·2026
Same journal

Effectiveness of Metformin in Preventing Colorectal Cancer Among Japanese Patients With Type 2 Diabetes: A Target Trial Emulation.

Pharmacoepidemiology and drug safety·2026
Same journal

Trends in Pharmacist-Prescribed Dispensing Records of HIV Pre-Exposure (2020-2025) and Post-Exposure Prophylaxis (2020-2024) in Brazil: A Time Series Analysis.

Pharmacoepidemiology and drug safety·2026
Same journal

French Consumption of Methylphenidate in Primary Care From 2016 to 2023, Impact of Prescribing Policy Changes-A Time-Series Analysis.

Pharmacoepidemiology and drug safety·2026
Same journal

Uptake and Use of Biologic Therapies in Paediatric Immune-Mediated Inflammatory Diseases: An Australian Population-Based Study.

Pharmacoepidemiology and drug safety·2026
See all related articles

Two Bayesian methods for pharmacovigilance offer early detection of drug-event associations. These quantitative methods provide similar results for frequent events, aiding in signal identification.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Biostatistics and Quantitative Methods
  • Epidemiology

Background:

  • Quantitative methods are crucial for analyzing adverse event data.
  • Bayesian approaches offer a probabilistic framework for signal detection.
  • Comparing novel Bayesian methods is essential for practical application.

Purpose of the Study:

  • To compare two recent Bayesian quantitative pharmacovigilance methods.
  • To evaluate their assumptions and resulting signals.
  • To outline practical strategies for their implementation.

Main Methods:

  • Methods were expressed in common terms to identify similarities and differences.
  • Extensions to both Bayesian methods were developed.
  • Empirical Bayes method applied to antihypertensive drug data.

Related Experiment Videos

  • Logarithm of proportional risk ratio used as the core metric.

    • Main Results:

    • Similar numerical results obtained for frequently reported adverse events.
    • Discrepancies noted for infrequently reported events.
    • Lower 5% quantile of posterior distribution helps distinguish signals from noise.
    • Most drug-event associations identified within the first year of data.
    • Early identified associations generally persisted over time.

    Conclusions:

    • Both Bayesian methods provide valuable early signals for potential drug-event associations.
    • These signals warrant further detailed evaluation by experts.
    • Quantitative pharmacovigilance aids in proactive drug safety monitoring.