PDA Journal of Pharmaceutical Science and Technology: 66 (5)

September/October 2012; Volume 66,Issue 5

Editorial

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Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India
Anurag Rathore

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 393; DOI: https://doi.org/10.5731/pdajpst.2012.00886

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Pre-use/Post-sterilization Integrity Testing of Sterilizing Grade Filters
PDA Pre Use/Post-Sterilization Integrity Test Task Force:, Karen Bartel, Hal Baseman, Gabriele Gori, Richard Levy, Hemisha Ly, Maik Jornitz, Russell Madsen, Michiel Rook and Sue Schniepp

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 394-395; DOI: https://doi.org/10.5731/pdajpst.2012.00885

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Considerations on Auditing and GxP Requirements along the Product Lifecycle
Stephan Rönninger, Siegfried Schmitt, Vijaya Rangavajhula, Emily Hough and Jim Lyda

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 396-402; DOI: https://doi.org/10.5731/pdajpst.2012.00881

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Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems
Seung-Yil Yoon, Hemi Sagi, Craig Goldhammer and Lei Li

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 403-419; DOI: https://doi.org/10.5731/pdajpst.2012.00878
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A Survey of Quality Attributes of Virus Spike Preparations Used in Clearance Studies
George Miesegaes, Scott Lute, Jessica Dement-Brown, Simran Kaushal, Daniel Strauss, Dayue Chen and Kurt Brorson

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 420-433; DOI: https://doi.org/10.5731/pdajpst.2012.00879
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Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions
Hirotaka Sudo, Michael O'driscoll, Kenji Nishiwaki, Yuji Kawamoto, Philip Gammell, Gerhard Schramm, Toni Wertli, Heino Prinz, Atsuhide Mori and Kazuhiro Sako

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 434-444; DOI: https://doi.org/10.5731/pdajpst.2012.00882

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Application of Flow Cytometry for Rapid Bioburden Screening in Vaccine Virus Production
Praful K. Bhusari, David E. Tabor, Ryan Yamagata and Mark S. Galinski

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 445-452; DOI: https://doi.org/10.5731/pdajpst.2012.00883
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Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80 °C
Brigitte Zuleger, Uwe Werner, Alexander Kort, Rene Glowienka, Engelbert Wehnes and Derek Duncan

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 453-465; DOI: https://doi.org/10.5731/pdajpst.2012.00884

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Drug Delivery from the Oral Cavity: A Focus on Mucoadhesive Buccal Drug Delivery Systems
Dattatraya Manohar Shinkar, Avinash Sridhar Dhake and Chitral Mallikarjuna Setty

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 466-500; DOI: https://doi.org/10.5731/pdajpst.2012.00877