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

Use of a Predictive Regression Model for Estimating Hold-Up Volume for Biologic Drug Product Presentations

Shyam B. Mehta, Srishty Subramanian, Rebecca Brown, Rowena D'Mello, Charlene Brisbane and Shouvik Roy
PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 290-300; DOI: https://doi.org/10.5731/pdajpst.2019.010728
Shyam B. Mehta
Teva Biopharmaceuticals, West Chester, PA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Srishty Subramanian
Teva Biopharmaceuticals, West Chester, PA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Rebecca Brown
Teva Biopharmaceuticals, West Chester, PA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Rowena D'Mello
Teva Biopharmaceuticals, West Chester, PA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Charlene Brisbane
Teva Biopharmaceuticals, West Chester, PA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Shouvik Roy
Teva Biopharmaceuticals, West Chester, PA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: shouvik.roy02@tevapharm.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Article Information

vol. 74 no. 3 290-300
DOI 
https://doi.org/10.5731/pdajpst.2019.010728
PubMed 
31732689

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 26, 2020.

Article Versions

  • previous version (November 15, 2019 - 07:57).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Shyam B. Mehta,
  2. Srishty Subramanian,
  3. Rebecca Brown,
  4. Rowena D'Mello,
  5. Charlene Brisbane and
  6. Shouvik Roy*
  1. Teva Biopharmaceuticals, West Chester, PA, USA
  1. ↵*Corresponding Author: Shouvik Roy, Drug Product Development and Operations, Biologics CMC, Teva Biopharmaceuticals, West Chester, PA 19380, E-mail: shouvik.roy02{at}tevapharm.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.

  • Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products
    Markus Blümel, Jing Liu, Isabella de Jong, Sarah Weiser, Jonas Fast, Jennifer Litowski, Melissa Shuman, Shyam B. Mehta, Leanne Amery, David Cheng Thiam Tan, Feng Jia, Dushyant Shekhawat, Camille Dagallier, Mina Emamzadeh, Annette Medina, Camilla Santos, Florian Gasser, Christian Urban
    Journal of Pharmaceutical Sciences 2023 112 9
  • Risk Mitigation of Plunger-Stopper Displacement Under Low Atmospheric Pressure by Establishing Design Space for Filling-Stoppering Process of Prefilled Syringes: A Design of Experiment (DoE) Approach
    Shyam B. Mehta, Joseph Cook, Wei Liu, Charlene Brisbane
    Journal of Pharmaceutical Sciences 2022 111 7
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 74 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 3
May/June 2020
  • Table of Contents
  • Index by Author
  • Complete Issue (PDF)
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.
Use of a Predictive Regression Model for Estimating Hold-Up Volume for Biologic Drug Product Presentations
(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.
10 + 4 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Use of a Predictive Regression Model for Estimating Hold-Up Volume for Biologic Drug Product Presentations
Shyam B. Mehta, Srishty Subramanian, Rebecca Brown, Rowena D'Mello, Charlene Brisbane, Shouvik Roy
PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 290-300; DOI: 10.5731/pdajpst.2019.010728

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Use of a Predictive Regression Model for Estimating Hold-Up Volume for Biologic Drug Product Presentations
Shyam B. Mehta, Srishty Subramanian, Rebecca Brown, Rowena D'Mello, Charlene Brisbane, Shouvik Roy
PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 290-300; DOI: 10.5731/pdajpst.2019.010728
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Results and Discussion
    • Conclusion
    • Conflict of Interest Declaration
    • Appendix
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Tolerance Interval Approach for the Determination of Overfill of Liquid Parenteral Drug Products
  • A Predictive Modeling Approach to Support the Overfill Volume Definition of Liquid-in-Vial Drug Products
  • 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

  • Container closure system
  • Biologic drug product
  • Hold-Up Volume
  • Fill volume specification
  • Label claim
  • Dosage form
  • Drug delivery system
  • Vials
  • prefilled syringe

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