Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Research ArticleResearch

Environmental Monitoring: Setting Alert and Action Limits Based on a Zero-Inflated Model

Harry Yang, Wei Zhao, Terrence O'day and William Fleming
PDA Journal of Pharmaceutical Science and Technology January 2013, 67 (1) 2-8; DOI: https://doi.org/10.5731/pdajpst.2013.00897
Harry Yang
MedImmune, LLC, Gaithersburg, MD
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: YangH@MedImmune.com
Wei Zhao
MedImmune, LLC, Gaithersburg, MD
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Terrence O'day
MedImmune, LLC, Gaithersburg, MD
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
William Fleming
MedImmune, LLC, Gaithersburg, MD
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    1. Sutton S
    . The environmental monitoring program in a GMP environment. Journal of GXP 2010, 14 (3), 22–30.
    OpenUrl
  2. 2.↵
    1. Wilson J. D
    . Setting alert/action limits for environmental monitoring programs. PDA J. Pharm. Sci. Technol. 2004, 58 (5), 254–260.
    OpenUrlAbstract/FREE Full Text
  3. 3.↵
    1. Conover W. J
    . Practical Nonparametric Statistics, 3rd ed. Wiley: New York, 1999.
  4. 4.↵
    1. Hoffman D
    . Negative binomial control limits for count data with extra-Poisson variation. Pharmaceutical Statistics 2004, 2 (2), 127–132.
    OpenUrl
  5. 5.↵
    1. Christensen A.,
    2. Melgaard H.,
    3. Iwersen J
    . Environmental monitoring based on a hierarchical Posson-Gamma model. J. Qual. Technol. 2003, 35 (3), 275–285.
    OpenUrl
  6. 6.↵
    1. Caputo R. A.,
    2. Huffman A
    . Environmental monitoring: data trending using a frequency model. PDA J. Pharm. Sci. Technol. 2004, 58 (5), 254–260.
    OpenUrlAbstract/FREE Full Text
  7. 7.↵
    1. Erdman D.,
    2. Jackson L.,
    3. Sinko A
    . Zero-inflated Poisson and zero-inflated negative binomial models using the COUNTREG procedure. SAS Global Forum 2008, Paper 322.
  8. 8.↵
    1. Lambert D
    . Zero-inflated Poisson regression models with an application to defects in manufacturing. Technometrics 1992, 34 (1), 1–14.
    OpenUrlCrossRefWeb of Science
  9. 9.↵
    SAS Institute, Inc. SAS/STAT user's guide, Version 9. SAS Institute: Cary, NC, 2009.
  10. 10.↵
    1. Long J. S
    . Regression Models for Categorical and Limited Dependent Variables. Sage Publications: Thousand Oaks, CA, 1997.
  11. 11.↵
    1. Neelon B. H.,
    2. O'Malley J.,
    3. Normand S. T
    . A Bayesian model for repeated measures zero-inflated count data with application to outpatient psychiatric service use. Stat. Modelling 2010, 10 (4), 421–439.
    OpenUrlPubMed
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 67 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 1
January/February 2013
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Environmental Monitoring: Setting Alert and Action Limits Based on a Zero-Inflated Model
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
1 + 19 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Environmental Monitoring: Setting Alert and Action Limits Based on a Zero-Inflated Model
Harry Yang, Wei Zhao, Terrence O'day, William Fleming
PDA Journal of Pharmaceutical Science and Technology Jan 2013, 67 (1) 2-8; DOI: 10.5731/pdajpst.2013.00897

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Environmental Monitoring: Setting Alert and Action Limits Based on a Zero-Inflated Model
Harry Yang, Wei Zhao, Terrence O'day, William Fleming
PDA Journal of Pharmaceutical Science and Technology Jan 2013, 67 (1) 2-8; DOI: 10.5731/pdajpst.2013.00897
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Zero-Inflated Negative Binomial Model
    • Parameter Estimation
    • Construction of Alert and Action Limits
    • Comparison with Other Methods
    • Discussion
    • Conclusions
    • Conflict of Interest Declaration
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Statistical Quality and Process Control in Biopharmaceutical Manufacturing--Practical Issues and Remedies
  • Statistical Method for Trending of Excursions in Clean Room Microbiological Monitoring Data
  • Setting Alert and Action Limits in the Presence of Significant Amount of Censoring in Data
  • Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data
  • Google Scholar

More in this TOC Section

  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
Show more Research

Similar Articles

Keywords

  • Alert and action limits
  • Environmental Monitoring
  • Zero-inflated model
  • Negative binomial distribution
  • Non-parametric methods
  • Poisson distribution

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire