PDA Journal of Pharmaceutical Science and Technology: 71 (5)

September/October 2017; Volume 71,Issue 5

Editorial

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Govind Rao

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 328-329; DOI: https://doi.org/10.5731/pdajpst.2017.001103

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2015/2016 Quality Risk Management Benchmarking Survey
Kelly Waldron, Emma Ramnarine and Jeffrey Hartman

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 330-345; DOI: https://doi.org/10.5731/pdajpst.2017.007526

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Extractables Screening of Polypropylene Resins Used in Pharmaceutical Packaging for Safety Hazards
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 346-367; DOI: https://doi.org/10.5731/pdajpst.2016.007401
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A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays
Ruojia Li, Weiguo Cai and Marcel Zocher

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 368-378; DOI: https://doi.org/10.5731/pdajpst.2016.007369

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Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial
Christopher L. Timmons, Chi Yuen Liu and Stefan Merkle

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 379-392; DOI: https://doi.org/10.5731/pdajpst.2017.007724
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Evaluation of Novel Process Indicators for Rapid Monitoring of Hydrogen Peroxide Decontamination Processes
N. P. McLeod, M. Clifford and J. M. Sutton

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 393-404; DOI: https://doi.org/10.5731/pdajpst.2016.007435
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Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products
Jay Bolden and Kelly Smith

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 405-412; DOI: https://doi.org/10.5731/pdajpst.2017.007849

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Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective
Anita Bawa, Sofia Asefi, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Fran Leira, Tracy Landeryou, Bindhu Reddy, Marie Murphy, Barbara Daddis and David Bain

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 413-420; DOI: https://doi.org/10.5731/pdajpst.2016.007351

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PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?
Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kara Follman, Karolyn Gale, Kassidy Good, Suzanne Kiani, Maik Jornitz, Morten Munk, Kevin O'Donnel, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther, Denyse Baker and Rich Levy

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 421-427; DOI: https://doi.org/10.5731/pdajpst.2017.008219