PDA Journal of Pharmaceutical Science and Technology: 70 (2)

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March/April 2016; Volume 70,Issue 2

Editorial

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PDA/FDA Virus & TSE Safety Conference
Kurt Brorson

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 93; DOI: https://doi.org/10.5731/pdajpst.2016.001095

Letter to the Editor

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Letter to the Editor
Oliver Stauffer

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 94-95; DOI: https://doi.org/10.5731/pdajpst.2016.001083
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Letter to the Editor – Response
Andrea Simonetti and Filippo Amari

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 96-98; DOI: https://doi.org/10.5731/pdajpst.2016.001093

Research

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Direct Detection of Burkholderia cepacia in Susceptible Pharmaceutical Products Using Semi-Nested PCR
Mohamed A. Attia, Amal E. Ali, Tamer M. Essam and Magdy A. Amin

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 99-108; DOI: https://doi.org/10.5731/pdajpst.2015.006049
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Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918
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Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler and Hanns-Christian Mahler

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 120-133; DOI: https://doi.org/10.5731/pdajpst.2015.006098
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Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
Patricia W. Cash, Roja Narwal, Sophia V. Levitskaya, Stephan Krause, Derek Murphy and Maryam Mazaheri

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 134-142; DOI: https://doi.org/10.5731/pdajpst.2015.006064
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Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump
Wendy Shieu, Dax Lamar, Oliver B. Stauch and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 143-156; DOI: https://doi.org/10.5731/pdajpst.2015.005926
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A Bayesian Approach to Residual Host Cell DNA Safety Assessment
Harry Yang and Jianchun Zhang

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 157-162; DOI: https://doi.org/10.5731/pdajpst.2015.006296

Conference Report

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Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti and David Tainsh

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 163-176; DOI: https://doi.org/10.5731/pdajpst.2015.006171
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Meeting Report: 2015 PDA Virus & TSE Safety Forum
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

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Parenteral Drug Association, Inc.