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There are 30773 results for: content related to: Interlaboratory Test for Detection of Cytotoxic Leachables arising from Single-Use Bags

  1. Analytical Leachables Studies

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Andrew D. Feilden, Andy Rignall, Pages: 417–447, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch17

  2. Determination of Extractables and Leachables from Single-Use Systems

    Chemie Ingenieur Technik

    Volume 85, Issue 1-2, February, 2013, Pages: 186–196, Weibing Ding

    Article first published online : 15 NOV 2012, DOI: 10.1002/cite.201200113

  3. Focus on Emerging Concepts

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 319–346, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch12

  4. On developing a process for conducting extractable–leachable assessment of components used for storage of biopharmaceuticals

    Journal of Pharmaceutical Sciences

    Volume 99, Issue 5, May 2010, Pages: 2209–2218, Aditya A. Wakankar, Y. John Wang, Eleanor Canova-Davis, Stacey Ma, Dieter Schmalzing, Josh Grieco, Terry Milby, Theresa Reynolds, Kellen Mazzarella, Ed Hoff, Stephen Gomez and Sherry Martin-Moe

    Article first published online : 28 DEC 2009, DOI: 10.1002/jps.22012

  5. Nomenclature and General Concepts

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 27–75, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch2

  6. Pharmaceutical Container Closure Systems: Selection and Qualification of Materials

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Douglas J. Ball, William P. Beierschmitt, Arthur J. Shaw, Pages: 217–240, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch12

  7. Product Maintenance

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 271–313, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch10

  8. Analytical Best Practices for the Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Daniel L. Norwood, Cheryl L. M. Stults, Lee M. Nagao, Pages: 153–183, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch10

  9. Analytical Techniques for Identification and Quantitation of Extractables and Leachables

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Daniel L. Norwood, Thomas N. Feinberg, James O. Mullis, Scott J. Pennino, Pages: 241–287, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch13

  10. Ambient analysis of leachable compounds from single-use bioreactors with desorption electrospray ionization time-of-flight mass spectrometry

    Rapid Communications in Mass Spectrometry

    Volume 28, Issue 21, 15 November 2014, Pages: 2285–2291, Jian Liu, Joseph H. Kennedy, Michael Ronk, Liliana Marghitoiu, Hans Lee and Yasser Nashed-Samuel

    Article first published online : 19 SEP 2014, DOI: 10.1002/rcm.7021

  11. You have free access to this content
    Interlaboratory Test for Detection of Cytotoxic Leachables arising from Single-Use Bags

    Chemie Ingenieur Technik

    Volume 85, Issue 4, April, 2013, Page: 396, Nina Steiger and Prof. Dr. Ing. Regine Eibl

    Article first published online : 22 MAR 2013, DOI: 10.1002/cite.201390026

    This article corrects:

    Interlaboratory Test for Detection of Cytotoxic Leachables arising from Single-Use Bags

    Vol. 85, Issue 1-2, 26–28, Article first published online: 3 DEC 2012

  12. Safety Thresholds in the Pharmaceutical Development Process for OINDP: An Industry Perspective

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    David Alexander, James Blanchard, Pages: 79–92, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch6

  13. Impact of Residual Impurities and Contaminants on Protein Stability

    Journal of Pharmaceutical Sciences

    Volume 103, Issue 5, May 2014, Pages: 1315–1330, Wei Wang, Arun Alphonse Ignatius and Santosh V. Thakkar

    Article first published online : 12 MAR 2014, DOI: 10.1002/jps.23931

  14. Introduction

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 1–26, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch1

  15. The Prototype Stage

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 157–190, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch5

  16. Extractables and leachables issues with the application of single use technology in the biopharmaceutical industry

    Journal of Chemical Technology and Biotechnology

    Volume 91, Issue 2, February 2016, Pages: 289–295, Ying Gao and Nigel Allison

    Article first published online : 29 OCT 2015, DOI: 10.1002/jctb.4824

  17. Overview of Leachables and Extractables in Orally Inhaled and Nasal Drug Products

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Douglas J. Ball, Daniel L. Norwood, Lee M. Nagao, Pages: 1–19, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch1

  18. The Analytical Evaluation Threshold (AET) and its Relationship to Safety Thresholds

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Daniel L. Norwood, James O. Mullis, Scott J. Pennino, Pages: 59–78, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch5

  19. Material Screening and Characterization

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 89–156, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch4

  20. Late Stage Product Development

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables

    Dennis Jenke, Pages: 229–247, 2008

    Published Online : 1 OCT 2008, DOI: 10.1002/9780470459416.ch7