PDA Journal of Pharmaceutical Science and Technology: 68 (5)

September/October 2014; Volume 68,Issue 5

Guest Editorial

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Process, People, Perfection: Learning from the Pioneers in Human Performance
Darren Whitman

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 384-385; DOI: https://doi.org/10.5731/pdajpst.2014.01008

Review

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Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients: Are They Critical Quality Attributes?
Anthony M. Cundell

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 386-393; DOI: https://doi.org/10.5731/pdajpst.2014.00997

Research

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Comparison of Different Incubation Conditions for Microbiological Environmental Monitoring
Oliver Gordon, Manfred Berchtold, Alexandra Staerk and David Roesti

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 394-406; DOI: https://doi.org/10.5731/pdajpst.2014.00994
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A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems
Dennis Jenke and Tage Carlson

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 407-455; DOI: https://doi.org/10.5731/pdajpst.2014.00995
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Analysis and Evaluation of Single-Use Bag Extractables for Validation in Biopharmaceutical Applications
Ina Pahl, Samuel Dorey, Magali Barbaroux, Bertille Lagrange and Heike Frankl

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 456-471; DOI: https://doi.org/10.5731/pdajpst.2014.00996
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Evidence Against a Bacterial Endotoxin Masking Effect in Biologic Drug Products by Limulus Amebocyte Lysate Detection
Jay S. Bolden, Mark E. Claerbout, Matthew K. Miner, Marie A. Murphy, Kelly R. Smith and Rob E. Warburton

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 472-477; DOI: https://doi.org/10.5731/pdajpst.2014.00999
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Investigation of the Detection Ability of an Intrinsic Fluorescence-Based Bioaerosol Detection System for Heat-Stressed Bacteria
Kanami Irie, Allison Scott and Norio Hasegawa

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 478-493; DOI: https://doi.org/10.5731/pdajpst.2014.01000

Technology/Application

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Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy
Jared S. Bee, Vadim V. Frey, Urooj Javed, Jonathan Chung, Marta L. Corcoran, Paul S. Roussel, Stephan O. Krause, Patricia W. Cash, Steven M. Bishop and Mariana N. Dimitrova

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 494-503; DOI: https://doi.org/10.5731/pdajpst.2014.00991
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A Method Utilizing Ultra-High Performance Liquid Chromatography with Ultraviolet and Mass Spectrometric Detection for the Analysis of Material Extracts Produced during a Controlled Extraction Study
Steven A. Zdravkovic, Matthew D. Bruss, Robert F. Piccoli and Derek M. Wood

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 504-526; DOI: https://doi.org/10.5731/pdajpst.2014.00992
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A New Glass Option for Parenteral Packaging
Robert A. Schaut, John S. Peanasky, Steven E. DeMartino and Susan L. Schiefelbein

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 527-534; DOI: https://doi.org/10.5731/pdajpst.2014.00998

PDA Paper

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PARENTERAL DRUG ASSOCIATION POINTS TO CONSIDER: Pharmaceutical Quality Metrics Updated September 2014
PDA June 2014 Definitions Task Force and December 2013 Points to Consider Authors, Steve Mendivil, Joyce Bloomfield, Vince Anicetti, Denyse Baker, Ian Elvins, John Farris, Gabriele Gori, Bob Kieffer, Edwin Martinez-Rivera, Marty Nealey, Pritesh Patel, Anil Sawant, Sue Schniepp, Anders Vinther and Glenn Wright

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 535-545; DOI: https://doi.org/10.5731/pdajpst.2014.01021

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Parenteral Drug Association, Inc.