Index by Author

May/June 2017; Volume 71,Issue 3

B

  1. Borbély-Jakab, Judit

    1. Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study
      Ildikó Ziegler, Judit Borbély-Jakab, Lilla Sugó and Réka J. Kovács
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 234-244; DOI: https://doi.org/10.5731/pdajpst.2016.007096

  2. Busse, Ursula

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

C

  1. Colao, Marcello

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

D

  1. Day, Eric S.

    1. Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress
      Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S. Day, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 172-188; DOI: https://doi.org/10.5731/pdajpst.2016.006726

E

  1. Edwards, Julia

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

  2. Eisner, Devon Roshan

    1. Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress
      Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S. Day, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 172-188; DOI: https://doi.org/10.5731/pdajpst.2016.006726

  3. Eissa, Mostafa Essam

    1. Quantitative Microbial Risk Assessment of Pharmaceutical Products
      Mostafa Essam Eissa
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 245-251; DOI: https://doi.org/10.5731/pdajpst.2016.007047

G

  1. Garcia, Fernando A.

    1. Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities
      Fernando A. Garcia and Michael W. Vandiver
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 189-205; DOI: https://doi.org/10.5731/pdajpst.2016.006882

  2. Gikanga, Benson

    1. Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress
      Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S. Day, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 172-188; DOI: https://doi.org/10.5731/pdajpst.2016.006726

  3. Gordon, Oliver

    1. Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products
      Oliver Gordon, Marcel Goverde, Alexandra Staerk and David Roesti
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 206-224; DOI: https://doi.org/10.5731/pdajpst.2016.007450

  4. Goverde, Marcel

    1. Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products
      Oliver Gordon, Marcel Goverde, Alexandra Staerk and David Roesti
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 206-224; DOI: https://doi.org/10.5731/pdajpst.2016.007450

J

  1. Jenke, Dennis R.

    1. Proper Accounting for Surface Area to Solution Volume Ratios in Exaggerated Extractions
      Dennis R. Jenke and Barrett E. Rabinow
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 225-233; DOI: https://doi.org/10.5731/pdajpst.2016.007195

  2. Jornitz, Maik

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

K

  1. Kovács, Réka J.

    1. Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study
      Ildikó Ziegler, Judit Borbély-Jakab, Lilla Sugó and Réka J. Kovács
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 234-244; DOI: https://doi.org/10.5731/pdajpst.2016.007096

M

  1. Maa, Yuh-Fun

    1. Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress
      Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S. Day, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 172-188; DOI: https://doi.org/10.5731/pdajpst.2016.006726

  2. Munk, Morten

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

O

  1. O'Donnell, Kevin

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

  2. Ovadia, Robert

    1. Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress
      Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S. Day, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 172-188; DOI: https://doi.org/10.5731/pdajpst.2016.006726

R

  1. Rabinow, Barrett E.

    1. Proper Accounting for Surface Area to Solution Volume Ratios in Exaggerated Extractions
      Dennis R. Jenke and Barrett E. Rabinow
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 225-233; DOI: https://doi.org/10.5731/pdajpst.2016.007195

  2. Ramnarine, Emma

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

  3. Roesti, David

    1. Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products
      Oliver Gordon, Marcel Goverde, Alexandra Staerk and David Roesti
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 206-224; DOI: https://doi.org/10.5731/pdajpst.2016.007450

S

  1. Seymour, Melissa

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

  2. Simianu, Mihaela

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

  3. Skeens, Lisa

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

  4. Smalley, Christopher J.

    1. Why is There a Problem with Data Integrity?
      Christopher J. Smalley
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 170-171; DOI: https://doi.org/10.5731/pdajpst.2017.001101

  5. Staerk, Alexandra

    1. Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products
      Oliver Gordon, Marcel Goverde, Alexandra Staerk and David Roesti
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 206-224; DOI: https://doi.org/10.5731/pdajpst.2016.007450

  6. Stauch, Oliver B.

    1. Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress
      Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S. Day, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 172-188; DOI: https://doi.org/10.5731/pdajpst.2016.006726

  7. Sugó, Lilla

    1. Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study
      Ildikó Ziegler, Judit Borbély-Jakab, Lilla Sugó and Réka J. Kovács
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 234-244; DOI: https://doi.org/10.5731/pdajpst.2016.007096

V

  1. Vandiver, Michael W.

    1. Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities
      Fernando A. Garcia and Michael W. Vandiver
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 189-205; DOI: https://doi.org/10.5731/pdajpst.2016.006882

  2. Vinther, Anders

    1. PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
      Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575

Z

  1. Ziegler, Ildikó

    1. Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study
      Ildikó Ziegler, Judit Borbély-Jakab, Lilla Sugó and Réka J. Kovács
      PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 234-244; DOI: https://doi.org/10.5731/pdajpst.2016.007096
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