PDA Journal of Pharmaceutical Science and Technology: 67 (4)

July/August 2013; Volume 67,Issue 4

Editorial

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Closing the Back Door
Govind Rao

PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 296; DOI: https://doi.org/10.5731/pdajpst.2013.00939

Research

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Characterization of the Evolution of the Pharmaceutical Regulatory Environment
Nader Shafiei, James L. Ford, Charles W. Morecroft, Paulo J. Lisboa and Mark J. Taylor

PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 297-306; DOI: https://doi.org/10.5731/pdajpst.2013.00930
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Transformation in the Pharmaceutical Industry—A Systematic Analysis of Operational Evidence
Nader Shafiei, James L. Ford, Charles W. Morecroft, Paulo J. Lisboa, Mark J. Taylor and Yusra Mouzughi

PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 307-322; DOI: https://doi.org/10.5731/pdajpst.2013.00924
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Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations
Ge Jiang, Monica Goss, Guiyang Li, Wendy Jing, Hong Shen, Kiyoshi Fujimori, Linda Le, Lyanne Wong, Zai-Qing Wen, Yasser Nashed-Samuel, Ken Riker, Abe Germansderfer, Paul Tsang and Margaret Ricci

PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 323-335; DOI: https://doi.org/10.5731/pdajpst.2013.00925
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Pharmaceutical Development of a Parenteral Formulation of Conivaptan Hydrochloride
Kazutoshi Ban, Ritsu Sonohara, Mitsunobu Yoshida, Kazuhiro Sako, Sinya Uchida and Noriyuki Namiki

PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 336-353; DOI: https://doi.org/10.5731/pdajpst.2013.00926
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A Compilation of Metals and Trace Elements Extracted from Materials Relevant to Pharmaceutical Applications such as Packaging Systems and Devices
Dennis Jenke, Christine Rivera, Tammy Mortensen, Parul Amin, Molly Chacko, Thang Tran and James Chum

PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 354-375; DOI: https://doi.org/10.5731/pdajpst.2013.00927
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A Preliminary Investigation into the Ability of Three Rapid Microbiological Methods To Detect Microorganisms in Hospital Intravenous Pharmaceuticals
Sarah Hiom, Stephen Denyer, Catherine Talbot, Jean-Yves Maillard, Paul Spark and Julian Smith

PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 376-386; DOI: https://doi.org/10.5731/pdajpst.2013.00928

Technology/Application

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Risk-based Methodology for Validation of Pharmaceutical Batch Processes
Frederick Wiles

PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 387-398; DOI: https://doi.org/10.5731/pdajpst.2013.00923
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A 5 Year Longitudinal Study of Water Quality for Final Rinsing in the Single Chamber Washer-Disinfector with a Reverse Osmosis Plant
Yushi Uetera, Kozue Kishii, Hiroshi Yasuhara, Naohito Kumada, Kyoji Moriya, Ryoichi Saito, Mitsuhiro Okazaki, Yoshiki Misawa and Kunio Kawamura

PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 399-411; DOI: https://doi.org/10.5731/pdajpst.2013.00931

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Parenteral Drug Association, Inc.