Advanced search
Publication Cover
Journal of Biopharmaceutical Statistics Volume 23, 2013 - Issue 4
Submit an article Journal homepage
492
Views
6
CrossRef citations to date
0
Altmetric
Original Articles

Evaluating the Performance of the ICH Guidelines for Shelf Life Estimation

Michelle Quinlan Novartis Oncology, Florham Park, New Jersey, USACorrespondence[email protected]
,
Walter Stroup University of Nebraska-Lincoln, Lincoln, Nebraska, USA
,
James Schwenke Applied Research Consultants, New Milford, Connecticut, USA
&
David Christopher Merck and Company, Kenilworth, New Jersey, USA
Pages 881-896 | Received 30 Jul 2011, Accepted 19 Feb 2012, Published online: 20 Jun 2013

Citations (6)

Keep up to date with the latest research on this topic with citation updates for this article.

Subscribe to citation updates

Read on this site (2)

Daniel Zakowiecki, Tobias Hess, Krzysztof Cal, Barbara Mikolaszek, Grzegorz Garbacz & Dorota Haznar-Garbacz. (2022) Directly compressible formulation of immediate release rosuvastatin calcium tablets stabilized with tribasic calcium phosphate. Pharmaceutical Development and Technology 27:4, pages 425-434.
Read now
W. Liu, J.C. Hsu, F. Bretz, A.J. Hayter & Y. Han. (2014) Shelf-life and its estimation in drug stability studies. Journal of Applied Statistics 41:9, pages 1989-2000.
Read now

Articles from other publishers (4)

Misbah Farooqui, Amir Sultan & Hassan Ahmed Khan. (2019) Thermostable Vaccines: Past, Present and Future Perspectives. Pakistan BioMedical Journal 2:1.
Crossref
Didier Clénet. (2018) Accurate prediction of vaccine stability under real storage conditions and during temperature excursions. European Journal of Pharmaceutics and Biopharmaceutics 125, pages 76-84.
Crossref
Robert Capen, David Christopher, Patrick Forenzo, Kim Huynh-Ba, David LeBlond, Oscar Liu, John O’Neill, Nate Patterson, Michelle Quinlan, Radhika Rajagopalan, James Schwenke & Walter Stroup. (2017) Evaluating Current Practices in Shelf Life Estimation. AAPS PharmSciTech 19:2, pages 668-680.
Crossref
Walter W. Stroup & Michelle Quinlan. 2016. Nonclinical Statistics for Pharmaceutical and Biotechnology Industries. Nonclinical Statistics for Pharmaceutical and Biotechnology Industries 575 604 .

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.