Index by Author

November/December 2016; Volume 70,Issue 6

B

  1. Backhaus, Jürgen

    1. Sterility Testing of Injectable Products: Evaluation of the Growth-based BacT/ALERT® 3D™ Dual T Culture System
      Stefan J. Kaiser, Nico T. Mutters, Jürgen Backhaus, Uwe Frank and Frank Günther
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 568-576; DOI: https://doi.org/10.5731/pdajpst.2016.006460

  2. Bain, David

    1. Risk Management in Biologics Technology Transfer
      Robert Toso, Jonathan Tsang, Jasmina Xie, Stephen Hohwald, David Bain and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 596-599; DOI: https://doi.org/10.5731/pdajpst.2016.006718

  3. Burdick, Richard K.

    1. On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation
      Harry Yang, Steven Novick and Richard K. Burdick
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 547-559; DOI: https://doi.org/10.5731/pdajpst.2016.006551

C

  1. Cao, Mingyan

    1. Qualification of a Quantitative Method for Monitoring Aspartate Isomerization of a Monoclonal Antibody by Focused Peptide Mapping
      Mingyan Cao, Wenjun (David) Mo, Anthony Shannon, Ziping Wei, Michael Washabaugh and Patricia Cash
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 490-507; DOI: https://doi.org/10.5731/pdajpst.2015.006239

  2. Cash, Patricia

    1. Qualification of a Quantitative Method for Monitoring Aspartate Isomerization of a Monoclonal Antibody by Focused Peptide Mapping
      Mingyan Cao, Wenjun (David) Mo, Anthony Shannon, Ziping Wei, Michael Washabaugh and Patricia Cash
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 490-507; DOI: https://doi.org/10.5731/pdajpst.2015.006239

  3. Cassart, Jean-Pol

    1. Advanced Virus Detection Technologies Interest Group (AVDTIG): Efforts on High Throughput Sequencing (HTS) for Virus Detection
      Arifa S. Khan, Dominick A. Vacante, Jean-Pol Cassart, Siemon H. S. Ng, Christophe Lambert, Robert L. Charlebois and Kathryn E. King
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 591-595; DOI: https://doi.org/10.5731/pdajpst.2016.007161

  4. Caulmare, John

    1. Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters
      Sal Giglia, John Caulmare, David Nhiem and David Porreca
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 577-590; DOI: https://doi.org/10.5731/pdajpst.2016.006437

  5. Charlebois, Robert L.

    1. Advanced Virus Detection Technologies Interest Group (AVDTIG): Efforts on High Throughput Sequencing (HTS) for Virus Detection
      Arifa S. Khan, Dominick A. Vacante, Jean-Pol Cassart, Siemon H. S. Ng, Christophe Lambert, Robert L. Charlebois and Kathryn E. King
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 591-595; DOI: https://doi.org/10.5731/pdajpst.2016.007161

  6. Ciavarella, Anthony B.

    1. Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry
      Anthony B. Ciavarella, Mansoor A. Khan, Abhay Gupta and Patrick J. Faustino
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 523-532; DOI: https://doi.org/10.5731/pdajpst.2015.006411

D

  1. Downing, Gregory

    1. A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
      Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R. Patel
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 533-546; DOI: https://doi.org/10.5731/pdajpst.2015.006338

F

  1. Faustino, Patrick J.

    1. Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry
      Anthony B. Ciavarella, Mansoor A. Khan, Abhay Gupta and Patrick J. Faustino
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 523-532; DOI: https://doi.org/10.5731/pdajpst.2015.006411

  2. Frank, Uwe

    1. Sterility Testing of Injectable Products: Evaluation of the Growth-based BacT/ALERT® 3D™ Dual T Culture System
      Stefan J. Kaiser, Nico T. Mutters, Jürgen Backhaus, Uwe Frank and Frank Günther
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 568-576; DOI: https://doi.org/10.5731/pdajpst.2016.006460

G

  1. Giglia, Sal

    1. Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters
      Sal Giglia, John Caulmare, David Nhiem and David Porreca
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 577-590; DOI: https://doi.org/10.5731/pdajpst.2016.006437

  2. Günther, Frank

    1. Sterility Testing of Injectable Products: Evaluation of the Growth-based BacT/ALERT® 3D™ Dual T Culture System
      Stefan J. Kaiser, Nico T. Mutters, Jürgen Backhaus, Uwe Frank and Frank Günther
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 568-576; DOI: https://doi.org/10.5731/pdajpst.2016.006460

  3. Gupta, Abhay

    1. Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry
      Anthony B. Ciavarella, Mansoor A. Khan, Abhay Gupta and Patrick J. Faustino
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 523-532; DOI: https://doi.org/10.5731/pdajpst.2015.006411

H

  1. Hafner, Mathias

    1. The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes
      Tobias Werk, Imke S. Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler and Mathias Hafner
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 508-522; DOI: https://doi.org/10.5731/pdajpst.2015.006387

  2. Hladik, Bernhard

    1. Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System
      Uwe Rothhaar, Michaela Klause and Bernhard Hladik
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 560-567; DOI: https://doi.org/10.5731/pdajpst.2016.006577

  3. Hohwald, Stephen

    1. Risk Management in Biologics Technology Transfer
      Robert Toso, Jonathan Tsang, Jasmina Xie, Stephen Hohwald, David Bain and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 596-599; DOI: https://doi.org/10.5731/pdajpst.2016.006718

  4. Huwyler, Joerg

    1. The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes
      Tobias Werk, Imke S. Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler and Mathias Hafner
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 508-522; DOI: https://doi.org/10.5731/pdajpst.2015.006387

K

  1. Kaiser, Stefan J.

    1. Sterility Testing of Injectable Products: Evaluation of the Growth-based BacT/ALERT® 3D™ Dual T Culture System
      Stefan J. Kaiser, Nico T. Mutters, Jürgen Backhaus, Uwe Frank and Frank Günther
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 568-576; DOI: https://doi.org/10.5731/pdajpst.2016.006460

  2. Khan, Arifa S.

    1. Advanced Virus Detection Technologies Interest Group (AVDTIG): Efforts on High Throughput Sequencing (HTS) for Virus Detection
      Arifa S. Khan, Dominick A. Vacante, Jean-Pol Cassart, Siemon H. S. Ng, Christophe Lambert, Robert L. Charlebois and Kathryn E. King
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 591-595; DOI: https://doi.org/10.5731/pdajpst.2016.007161

  3. Khan, Mansoor A.

    1. Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry
      Anthony B. Ciavarella, Mansoor A. Khan, Abhay Gupta and Patrick J. Faustino
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 523-532; DOI: https://doi.org/10.5731/pdajpst.2015.006411

  4. King, Kathryn E.

    1. Advanced Virus Detection Technologies Interest Group (AVDTIG): Efforts on High Throughput Sequencing (HTS) for Virus Detection
      Arifa S. Khan, Dominick A. Vacante, Jean-Pol Cassart, Siemon H. S. Ng, Christophe Lambert, Robert L. Charlebois and Kathryn E. King
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 591-595; DOI: https://doi.org/10.5731/pdajpst.2016.007161

  5. Klause, Michaela

    1. Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System
      Uwe Rothhaar, Michaela Klause and Bernhard Hladik
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 560-567; DOI: https://doi.org/10.5731/pdajpst.2016.006577

L

  1. Lambert, Christophe

    1. Advanced Virus Detection Technologies Interest Group (AVDTIG): Efforts on High Throughput Sequencing (HTS) for Virus Detection
      Arifa S. Khan, Dominick A. Vacante, Jean-Pol Cassart, Siemon H. S. Ng, Christophe Lambert, Robert L. Charlebois and Kathryn E. King
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 591-595; DOI: https://doi.org/10.5731/pdajpst.2016.007161

  2. Liu, Jun

    1. A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
      Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R. Patel
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 533-546; DOI: https://doi.org/10.5731/pdajpst.2015.006338

  3. Ludwig, Imke S.

    1. The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes
      Tobias Werk, Imke S. Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler and Mathias Hafner
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 508-522; DOI: https://doi.org/10.5731/pdajpst.2015.006387

  4. Luemkemann, Joerg

    1. The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes
      Tobias Werk, Imke S. Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler and Mathias Hafner
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 508-522; DOI: https://doi.org/10.5731/pdajpst.2015.006387

M

  1. Mahler, Hanns-Christian

    1. The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes
      Tobias Werk, Imke S. Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler and Mathias Hafner
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 508-522; DOI: https://doi.org/10.5731/pdajpst.2015.006387

  2. Medley, Colin D.

    1. A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
      Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R. Patel
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 533-546; DOI: https://doi.org/10.5731/pdajpst.2015.006338

  3. Mo, Wenjun (David)

    1. Qualification of a Quantitative Method for Monitoring Aspartate Isomerization of a Monoclonal Antibody by Focused Peptide Mapping
      Mingyan Cao, Wenjun (David) Mo, Anthony Shannon, Ziping Wei, Michael Washabaugh and Patricia Cash
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 490-507; DOI: https://doi.org/10.5731/pdajpst.2015.006239

  4. Mutters, Nico T.

    1. Sterility Testing of Injectable Products: Evaluation of the Growth-based BacT/ALERT® 3D™ Dual T Culture System
      Stefan J. Kaiser, Nico T. Mutters, Jürgen Backhaus, Uwe Frank and Frank Günther
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 568-576; DOI: https://doi.org/10.5731/pdajpst.2016.006460

N

  1. Ng, Siemon H. S.

    1. Advanced Virus Detection Technologies Interest Group (AVDTIG): Efforts on High Throughput Sequencing (HTS) for Virus Detection
      Arifa S. Khan, Dominick A. Vacante, Jean-Pol Cassart, Siemon H. S. Ng, Christophe Lambert, Robert L. Charlebois and Kathryn E. King
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 591-595; DOI: https://doi.org/10.5731/pdajpst.2016.007161

  2. Nhiem, David

    1. Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters
      Sal Giglia, John Caulmare, David Nhiem and David Porreca
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 577-590; DOI: https://doi.org/10.5731/pdajpst.2016.006437

  3. Novick, Steven

    1. On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation
      Harry Yang, Steven Novick and Richard K. Burdick
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 547-559; DOI: https://doi.org/10.5731/pdajpst.2016.006551

P

  1. Patel, Ankit R.

    1. A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
      Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R. Patel
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 533-546; DOI: https://doi.org/10.5731/pdajpst.2015.006338

  2. Pizarro, Shelly

    1. A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
      Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R. Patel
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 533-546; DOI: https://doi.org/10.5731/pdajpst.2015.006338

  3. Porreca, David

    1. Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters
      Sal Giglia, John Caulmare, David Nhiem and David Porreca
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 577-590; DOI: https://doi.org/10.5731/pdajpst.2016.006437

R

  1. Rao, Govind

    1. Winds of Change
      Govind Rao
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 489; DOI: https://doi.org/10.5731/pdajpst.2015.001098

  2. Rothhaar, Uwe

    1. Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System
      Uwe Rothhaar, Michaela Klause and Bernhard Hladik
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 560-567; DOI: https://doi.org/10.5731/pdajpst.2016.006577

S

  1. Shannon, Anthony

    1. Qualification of a Quantitative Method for Monitoring Aspartate Isomerization of a Monoclonal Antibody by Focused Peptide Mapping
      Mingyan Cao, Wenjun (David) Mo, Anthony Shannon, Ziping Wei, Michael Washabaugh and Patricia Cash
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 490-507; DOI: https://doi.org/10.5731/pdajpst.2015.006239

  2. Shieh, Ian C.

    1. A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
      Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R. Patel
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 533-546; DOI: https://doi.org/10.5731/pdajpst.2015.006338

T

  1. Toso, Robert

    1. Risk Management in Biologics Technology Transfer
      Robert Toso, Jonathan Tsang, Jasmina Xie, Stephen Hohwald, David Bain and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 596-599; DOI: https://doi.org/10.5731/pdajpst.2016.006718

  2. Tsang, Jonathan

    1. Risk Management in Biologics Technology Transfer
      Robert Toso, Jonathan Tsang, Jasmina Xie, Stephen Hohwald, David Bain and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 596-599; DOI: https://doi.org/10.5731/pdajpst.2016.006718

V

  1. Vacante, Dominick A.

    1. Advanced Virus Detection Technologies Interest Group (AVDTIG): Efforts on High Throughput Sequencing (HTS) for Virus Detection
      Arifa S. Khan, Dominick A. Vacante, Jean-Pol Cassart, Siemon H. S. Ng, Christophe Lambert, Robert L. Charlebois and Kathryn E. King
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 591-595; DOI: https://doi.org/10.5731/pdajpst.2016.007161

W

  1. Washabaugh, Michael

    1. Qualification of a Quantitative Method for Monitoring Aspartate Isomerization of a Monoclonal Antibody by Focused Peptide Mapping
      Mingyan Cao, Wenjun (David) Mo, Anthony Shannon, Ziping Wei, Michael Washabaugh and Patricia Cash
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 490-507; DOI: https://doi.org/10.5731/pdajpst.2015.006239

  2. Wei, Ziping

    1. Qualification of a Quantitative Method for Monitoring Aspartate Isomerization of a Monoclonal Antibody by Focused Peptide Mapping
      Mingyan Cao, Wenjun (David) Mo, Anthony Shannon, Ziping Wei, Michael Washabaugh and Patricia Cash
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 490-507; DOI: https://doi.org/10.5731/pdajpst.2015.006239

  3. Werk, Tobias

    1. The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes
      Tobias Werk, Imke S. Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler and Mathias Hafner
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 508-522; DOI: https://doi.org/10.5731/pdajpst.2015.006387

  4. Willison-Parry, Derek

    1. Risk Management in Biologics Technology Transfer
      Robert Toso, Jonathan Tsang, Jasmina Xie, Stephen Hohwald, David Bain and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 596-599; DOI: https://doi.org/10.5731/pdajpst.2016.006718

X

  1. Xiao, Nina J.

    1. A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
      Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R. Patel
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 533-546; DOI: https://doi.org/10.5731/pdajpst.2015.006338

  2. Xie, Jasmina

    1. Risk Management in Biologics Technology Transfer
      Robert Toso, Jonathan Tsang, Jasmina Xie, Stephen Hohwald, David Bain and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 596-599; DOI: https://doi.org/10.5731/pdajpst.2016.006718

Y

  1. Yang, Harry

    1. On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation
      Harry Yang, Steven Novick and Richard K. Burdick
      PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 547-559; DOI: https://doi.org/10.5731/pdajpst.2016.006551
Back to top

In This Issue