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PDA Journal of Pharmaceutical Science and Technology

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  • Content
    • Current Issue
    • Past Issues
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  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
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    • Author Resources / Submit
    • Reviewer Resources
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Index by Author

September/October 2017; Volume 71,Issue 5
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

A

  1. Arbesser-Rastburg, Christine

    1. You have access
      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. Asefi, Sofia

    1. You have access
      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

B

  1. Bain, David

    1. You have access
      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. Baker, Denyse

    1. You have access
      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. Bawa, Anita

    1. You have access
      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
  4. Bolden, Jay

    1. You have access
      Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products
      Jay Bolden and Kelly Smith
      PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 405-412; DOI: https://doi.org/10.5731/pdajpst.2017.007849
  5. Busse, Ursula

    1. You have access
      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

C

  1. Cai, Weiguo

    1. You have access
      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
  2. Clifford, M.

    1. You have access
      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
  3. Colao, Marcello

    1. You have access
      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

D

  1. Daddis, Barbara

    1. You have access
      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

E

  1. Edwards, Julia

    1. You have access
      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

F

  1. Follman, Kara

    1. You have access
      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

G

  1. Gale, Karolyn

    1. You have access
      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
  2. Good, Kassidy

    1. You have access
      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

H

  1. Hartman, Jeffrey

    1. You have access
      2015/2016 Quality Risk Management Benchmarking Survey
      Kelly Waldron, Emma Ramnarine and Jeffrey Hartman
      PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 330-345; DOI: https://doi.org/10.5731/pdajpst.2017.007526

J

  1. Jenke, Dennis

    1. You have access
      Extractables Screening of Polypropylene Resins Used in Pharmaceutical Packaging for Safety Hazards
      Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 346-367; DOI: https://doi.org/10.5731/pdajpst.2016.007401
  2. Jornitz, Maik

    1. You have access
      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

K

  1. Kiani, Suzanne

    1. You have access
      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

L

  1. Landeryou, Tracy

    1. You have access
      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. Leira, Fran

    1. You have access
      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
  3. Levy, Rich

    1. You have access
      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
  4. Li, Ruojia

    1. You have access
      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
  5. Liu, Chi Yuen

    1. You have access
      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

M

  1. McLeod, N. P.

    1. You have access
      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
  2. Merkle, Stefan

    1. You have access
      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
  3. Munk, Morten

    1. You have access
      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
  4. Murphy, Marie

    1. You have access
      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

O

  1. O'Donnel, Kevin

    1. You have access
      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

P

  1. Paul, Mousumi

    1. You have access
      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

R

  1. Ramnarine, Emma

    1. You have access
      2015/2016 Quality Risk Management Benchmarking Survey
      Kelly Waldron, Emma Ramnarine and Jeffrey Hartman
      PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 330-345; DOI: https://doi.org/10.5731/pdajpst.2017.007526
    2. You have access
      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
  2. Ramsey, Stephanie

    1. You have access
      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
  3. Rao, Govind

    1. You have access
      You “Like” Us!
      Govind Rao
      PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 328-329; DOI: https://doi.org/10.5731/pdajpst.2017.001103
  4. Reddy, Bindhu

    1. You have access
      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

S

  1. Seymour, Melissa

    1. You have access
      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
  2. Simianu, Mihaela

    1. You have access
      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. Skeens, Lisa

    1. You have access
      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
  4. Smith, Kelly

    1. You have access
      Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products
      Jay Bolden and Kelly Smith
      PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 405-412; DOI: https://doi.org/10.5731/pdajpst.2017.007849
  5. Sutton, J. M.

    1. You have access
      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

T

  1. Timmons, Christopher L.

    1. You have access
      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

V

  1. Vinther, Anders

    1. You have access
      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

W

  1. Waldron, Kelly

    1. You have access
      2015/2016 Quality Risk Management Benchmarking Survey
      Kelly Waldron, Emma Ramnarine and Jeffrey Hartman
      PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 330-345; DOI: https://doi.org/10.5731/pdajpst.2017.007526

Z

  1. Zocher, Marcel

    1. You have access
      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
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 71 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 5
September/October 2017
  • Table of Contents
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  • A Commentary on Several Study Design Considerations Pertaining to the Screening of Substances Extracted and/or Leached from Pharmaceutical Contact Materials
  • Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
  • Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
  • Quantifying Operator Subjectivity within Flow Cytometry Data Analysis as a Source of Measurement Uncertainty and the Impact of Experience on Results
  • Low-Volume Aseptic Filling Using a Linear Peristaltic Pump
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