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

The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim

Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg and John Schreffler
PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 552-561; DOI: https://doi.org/10.5731/pdajpst.2019.010116
Dwaine Banton
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Dominick Vacante
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ben Bulthuis
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Josh Goldstein
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michael Wineburg
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
John Schreffler
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: jschreff@its.jnj.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Article Information

vol. 73 no. 6 552-561
DOI 
https://doi.org/10.5731/pdajpst.2019.010116
PubMed 
31101710

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 10, 2019.

Article Versions

  • previous version (May 17, 2019 - 05:08).
  • previous version (May 28, 2019 - 09:37).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Dwaine Banton,
  2. Dominick Vacante,
  3. Ben Bulthuis,
  4. Josh Goldstein,
  5. Michael Wineburg and
  6. John Schreffler*
  1. Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
  1. ↵* Corresponding Author: 200 Great Valley Parkway, Malvern, PA 19355; Telephone: 610-651-6386; e-mail: jschreff{at}its.jnj.com
View Full Text

Cited By...

  • 2 Citations
  • Google Scholar

This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

  • Application of machine learning methods to pathogen safety evaluation in biological manufacturing processes
    Shyam Panjwani, Ivan Cui, Konstantinos Spetsieris, Michal Mleczko, Wensheng Wang, June X. Zou, Mohammad Anwaruzzaman, Shawn Liu, Roger Canales, Oliver Hesse
    Biotechnology Progress 2021 37 3
  • The current state of Bayesian methods in nonclinical pharmaceutical statistics: Survey results and recommendations from the DIA/ASA‐BIOP Nonclinical Bayesian Working Group
    Paul Faya, Perceval Sondag, Steven Novick, Dwaine Banton, John W. Seaman, Jr, James D. Stamey, Bruno Boulanger
    Pharmaceutical Statistics 2021 20 2
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 6
November/December 2019
  • 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.
The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
(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.
9 + 2 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg, John Schreffler
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 552-561; DOI: 10.5731/pdajpst.2019.010116

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg, John Schreffler
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 552-561; DOI: 10.5731/pdajpst.2019.010116
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Materials & Methods
    • Statistical Analyses
    • Results & 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...

  • Proceedings of the 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding
  • Twenty plus Years of Data Demonstrating Virus Filtration as an Effective and Robust Step for Large Virus Removal
  • 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

  • Viral inactivation
  • Modular viral clearance
  • Modular claim
  • Generic claim
  • Low pH inactivation
  • Viral clearance
  • Log reduction value (LRV)
  • Murine leukemia virus (MuLV)
  • Retrovirus
  • Viral Safety

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