Table of Contents

September/October 2014; Volume 68,Issue 5

  1. Anicetti, Vince

    1. PARENTERAL DRUG ASSOCIATION POINTS TO CONSIDER: Pharmaceutical Quality Metrics Updated September 2014
      PDA June 2014 Definitions Task Force and December 2013 Points to Consider Authors, Steve Mendivil, Joyce Bloomfield, Vince Anicetti, Denyse Baker, Ian Elvins, John Farris, Gabriele Gori, Bob Kieffer, Edwin Martinez-Rivera, Marty Nealey, Pritesh Patel, Anil Sawant, Sue Schniepp, Anders Vinther and Glenn Wright
      PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 535-545; DOI: https://doi.org/10.5731/pdajpst.2014.01021

  2. Baker, Denyse

    1. PARENTERAL DRUG ASSOCIATION POINTS TO CONSIDER: Pharmaceutical Quality Metrics Updated September 2014
      PDA June 2014 Definitions Task Force and December 2013 Points to Consider Authors, Steve Mendivil, Joyce Bloomfield, Vince Anicetti, Denyse Baker, Ian Elvins, John Farris, Gabriele Gori, Bob Kieffer, Edwin Martinez-Rivera, Marty Nealey, Pritesh Patel, Anil Sawant, Sue Schniepp, Anders Vinther and Glenn Wright
      PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 535-545; DOI: https://doi.org/10.5731/pdajpst.2014.01021

  3. Barbaroux, Magali

    1. Analysis and Evaluation of Single-Use Bag Extractables for Validation in Biopharmaceutical Applications
      Ina Pahl, Samuel Dorey, Magali Barbaroux, Bertille Lagrange and Heike Frankl
      PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 456-471; DOI: https://doi.org/10.5731/pdajpst.2014.00996

  4. Bee, Jared S.

    1. Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy
      Jared S. Bee, Vadim V. Frey, Urooj Javed, Jonathan Chung, Marta L. Corcoran, Paul S. Roussel, Stephan O. Krause, Patricia W. Cash, Steven M. Bishop and Mariana N. Dimitrova
      PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 494-503; DOI: https://doi.org/10.5731/pdajpst.2014.00991

  5. Berchtold, Manfred

    1. Comparison of Different Incubation Conditions for Microbiological Environmental Monitoring
      Oliver Gordon, Manfred Berchtold, Alexandra Staerk and David Roesti
      PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 394-406; DOI: https://doi.org/10.5731/pdajpst.2014.00994

  6. Bishop, Steven M.

    1. Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy
      Jared S. Bee, Vadim V. Frey, Urooj Javed, Jonathan Chung, Marta L. Corcoran, Paul S. Roussel, Stephan O. Krause, Patricia W. Cash, Steven M. Bishop and Mariana N. Dimitrova
      PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 494-503; DOI: https://doi.org/10.5731/pdajpst.2014.00991

  7. Bloomfield, Joyce

    1. PARENTERAL DRUG ASSOCIATION POINTS TO CONSIDER: Pharmaceutical Quality Metrics Updated September 2014
      PDA June 2014 Definitions Task Force and December 2013 Points to Consider Authors, Steve Mendivil, Joyce Bloomfield, Vince Anicetti, Denyse Baker, Ian Elvins, John Farris, Gabriele Gori, Bob Kieffer, Edwin Martinez-Rivera, Marty Nealey, Pritesh Patel, Anil Sawant, Sue Schniepp, Anders Vinther and Glenn Wright
      PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 535-545; DOI: https://doi.org/10.5731/pdajpst.2014.01021

  8. Bolden, Jay S.

    1. Evidence Against a Bacterial Endotoxin Masking Effect in Biologic Drug Products by Limulus Amebocyte Lysate Detection
      Jay S. Bolden, Mark E. Claerbout, Matthew K. Miner, Marie A. Murphy, Kelly R. Smith and Rob E. Warburton
      PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 472-477; DOI: https://doi.org/10.5731/pdajpst.2014.00999

  9. Bruss, Matthew D.

    1. A Method Utilizing Ultra-High Performance Liquid Chromatography with Ultraviolet and Mass Spectrometric Detection for the Analysis of Material Extracts Produced during a Controlled Extraction Study
      Steven A. Zdravkovic, Matthew D. Bruss, Robert F. Piccoli and Derek M. Wood
      PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 504-526; DOI: https://doi.org/10.5731/pdajpst.2014.00992

  10. Carlson, Tage

    1. A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems
      Dennis Jenke and Tage Carlson
      PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 407-455; DOI: https://doi.org/10.5731/pdajpst.2014.00995
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