Table of Contents

September/October 2017; Volume 71,Issue 5

  1. Leira, Fran

    1. 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

  2. Levy, Rich

    1. 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

  3. Li, Ruojia

    1. 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

  4. Liu, Chi Yuen

    1. 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

  5. Mcleod, N. P.

    1. 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

  6. Merkle, Stefan

    1. 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

  7. Munk, Morten

    1. 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

  8. Murphy, Marie

    1. 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

  9. O'donnel, Kevin

    1. 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

  10. Paul, Mousumi

    1. 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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