PDA Journal of Pharmaceutical Science and Technology: 69 (6)

November/December 2015; Volume 69,Issue 6

Editor's Note

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Preventing a Pharma Crash: A 30,000 Foot View
Govind Rao

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 666; DOI: https://doi.org/10.5731/pdajpst.2015.01091

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Taking Flight
Norman R. Augustine

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 667-668; DOI: https://doi.org/10.5731/pdajpst.2015.01092

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Filtration of Glass Delamination Particles with West Pharmaceutical Vial Adapters
Elinor H. Zarour-Shalev, Yaron Ovadia, Oren Tuchmay, Graham Reynolds and Nimrod Lev

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 669-676; DOI: https://doi.org/10.5731/pdajpst.2015.01076
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Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 677-712; DOI: https://doi.org/10.5731/pdajpst.2015.01077
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Low Leachable Container System Consisting of a Polymer-Based Syringe with Chlorinated Isoprene Isobutene Rubber Plunger Stopper
Hideaki Kiminami, Katsuyuki Takeuchi, Koji Nakamura, Yoshihiko Abe, Philippe Lauwers, William Dierick, Keisuke Yoshino and Shigeru Suzuki

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 713-724; DOI: https://doi.org/10.5731/pdajpst.2015.01080
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A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error
Harry Yang and Jianchun Zhang

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 725-735; DOI: https://doi.org/10.5731/pdajpst.2015.01081

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Increasing Product Confidence—Shifting Paradigms
Marla Phillips, Vishal Kashyap and Mee-Shew Cheung

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 736-742; DOI: https://doi.org/10.5731/pdajpst.2015.01075
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Charting and Evaluation of Environmental Microbial Monitoring Data
Raphael Bar

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 743-761; DOI: https://doi.org/10.5731/pdajpst.2015.01079

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Data Integrity—A Study of Current Regulatory Thinking and Action
Nader Shafiei, Regis De Montardy and Edwin Rivera-Martinez

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 762-770; DOI: https://doi.org/10.5731/pdajpst.2015.01082