Table of Contents

March/April 2016; Volume 70,Issue 2

A

  1. Adler, Michael

    1. Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
      Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler and Hanns-Christian Mahler
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 120-133; DOI: https://doi.org/10.5731/pdajpst.2015.006098

  2. Ali, Amal E.

    1. Direct Detection of Burkholderia cepacia in Susceptible Pharmaceutical Products Using Semi-Nested PCR
      Mohamed A. Attia, Amal E. Ali, Tamer M. Essam and Magdy A. Amin
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 99-108; DOI: https://doi.org/10.5731/pdajpst.2015.006049

  3. Amari, Filippo

    1. Letter to the Editor – Response
      Andrea Simonetti and Filippo Amari
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 96-98; DOI: https://doi.org/10.5731/pdajpst.2016.001093

  4. Amin, Magdy A.

    1. Direct Detection of Burkholderia cepacia in Susceptible Pharmaceutical Products Using Semi-Nested PCR
      Mohamed A. Attia, Amal E. Ali, Tamer M. Essam and Magdy A. Amin
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 99-108; DOI: https://doi.org/10.5731/pdajpst.2015.006049

  5. Attia, Mohamed A.

    1. Direct Detection of Burkholderia cepacia in Susceptible Pharmaceutical Products Using Semi-Nested PCR
      Mohamed A. Attia, Amal E. Ali, Tamer M. Essam and Magdy A. Amin
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 99-108; DOI: https://doi.org/10.5731/pdajpst.2015.006049

B

  1. Blümel, Johannes

    1. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

  2. Brorson, Kurt

    1. PDA/FDA Virus & TSE Safety Conference
      Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 93; DOI: https://doi.org/10.5731/pdajpst.2016.001095
    2. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

  3. Brown, Helen

    1. Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
      Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler and Hanns-Christian Mahler
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 120-133; DOI: https://doi.org/10.5731/pdajpst.2015.006098

C

  1. Cash, Patricia W.

    1. Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
      Patricia W. Cash, Roja Narwal, Sophia V. Levitskaya, Stephan Krause, Derek Murphy and Maryam Mazaheri
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 134-142; DOI: https://doi.org/10.5731/pdajpst.2015.006064

  2. Chen, Dayue

    1. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

  3. Chen, Qi

    1. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

  4. Cook, Graham

    1. Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
      Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti and David Tainsh
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 163-176; DOI: https://doi.org/10.5731/pdajpst.2015.006171

E

  1. Eder, Juergen

    1. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
      Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918

  2. Essam, Tamer M.

    1. Direct Detection of Burkholderia cepacia in Susceptible Pharmaceutical Products Using Semi-Nested PCR
      Mohamed A. Attia, Amal E. Ali, Tamer M. Essam and Magdy A. Amin
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 99-108; DOI: https://doi.org/10.5731/pdajpst.2015.006049

F

  1. France, Georges

    1. Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
      Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti and David Tainsh
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 163-176; DOI: https://doi.org/10.5731/pdajpst.2015.006171

  2. Fritsch, Kamila

    1. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
      Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918

G

  1. Gröner, Albrecht

    1. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

H

  1. Holte, Øyvind

    1. Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
      Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti and David Tainsh
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 163-176; DOI: https://doi.org/10.5731/pdajpst.2015.006171

  2. Huwyler, Joerg

    1. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
      Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918

K

  1. Krause, Stephan

    1. Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
      Patricia W. Cash, Roja Narwal, Sophia V. Levitskaya, Stephan Krause, Derek Murphy and Maryam Mazaheri
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 134-142; DOI: https://doi.org/10.5731/pdajpst.2015.006064

  2. Kreil, Thomas R.

    1. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

L

  1. Lamar, Dax

    1. Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump
      Wendy Shieu, Dax Lamar, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 143-156; DOI: https://doi.org/10.5731/pdajpst.2015.005926

  2. Levitskaya, Sophia V.

    1. Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
      Patricia W. Cash, Roja Narwal, Sophia V. Levitskaya, Stephan Krause, Derek Murphy and Maryam Mazaheri
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 134-142; DOI: https://doi.org/10.5731/pdajpst.2015.006064

  3. Lorenti, Giampiero

    1. Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
      Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti and David Tainsh
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 163-176; DOI: https://doi.org/10.5731/pdajpst.2015.006171

M

  1. Maa, Yuh-Fun

    1. Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump
      Wendy Shieu, Dax Lamar, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 143-156; DOI: https://doi.org/10.5731/pdajpst.2015.005926

  2. Mahler, Hanns-Christian

    1. Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
      Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler and Hanns-Christian Mahler
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 120-133; DOI: https://doi.org/10.5731/pdajpst.2015.006098
    2. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
      Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918

  3. Mathaes, Roman

    1. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
      Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918

  4. Mazaheri, Maryam

    1. Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
      Patricia W. Cash, Roja Narwal, Sophia V. Levitskaya, Stephan Krause, Derek Murphy and Maryam Mazaheri
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 134-142; DOI: https://doi.org/10.5731/pdajpst.2015.006064

  5. Mohl, Silke

    1. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
      Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918

  6. Murphy, Derek

    1. Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
      Patricia W. Cash, Roja Narwal, Sophia V. Levitskaya, Stephan Krause, Derek Murphy and Maryam Mazaheri
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 134-142; DOI: https://doi.org/10.5731/pdajpst.2015.006064

N

  1. Narwal, Roja

    1. Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
      Patricia W. Cash, Roja Narwal, Sophia V. Levitskaya, Stephan Krause, Derek Murphy and Maryam Mazaheri
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 134-142; DOI: https://doi.org/10.5731/pdajpst.2015.006064

  2. Nieto, Alejandra

    1. Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
      Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler and Hanns-Christian Mahler
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 120-133; DOI: https://doi.org/10.5731/pdajpst.2015.006098

  3. Nikoloff, Jonas

    1. Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
      Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler and Hanns-Christian Mahler
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 120-133; DOI: https://doi.org/10.5731/pdajpst.2015.006098

P

  1. Posset, Tobias

    1. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
      Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918

R

  1. Roehl, Holger

    1. Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
      Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler and Hanns-Christian Mahler
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 120-133; DOI: https://doi.org/10.5731/pdajpst.2015.006098

  2. Roggo, Yves

    1. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
      Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918

  3. Ruffing, Michel

    1. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

  4. Ruiz, Sol

    1. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

S

  1. Scott, Dorothy

    1. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

  2. Shieu, Wendy

    1. Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump
      Wendy Shieu, Dax Lamar, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 143-156; DOI: https://doi.org/10.5731/pdajpst.2015.005926

  3. Silvester, Glenda

    1. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

  4. Simonetti, Andrea

    1. Letter to the Editor – Response
      Andrea Simonetti and Filippo Amari
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 96-98; DOI: https://doi.org/10.5731/pdajpst.2016.001093

  5. Stauch, Oliver B.

    1. Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump
      Wendy Shieu, Dax Lamar, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 143-156; DOI: https://doi.org/10.5731/pdajpst.2015.005926

  6. Stauffer, Oliver

    1. Letter to the Editor
      Oliver Stauffer
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 94-95; DOI: https://doi.org/10.5731/pdajpst.2016.001083

  7. Streubel, Alexander

    1. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
      Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918

T

  1. Tainsh, David

    1. Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)
      Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti and David Tainsh
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 163-176; DOI: https://doi.org/10.5731/pdajpst.2015.006171

W

  1. Willkommen, Hannelore

    1. Meeting Report: 2015 PDA Virus & TSE Safety Forum
      Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Thomas R. Kreil, Michel Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 177-188; DOI: https://doi.org/10.5731/pdajpst.2016.006569

Y

  1. Yang, Harry

    1. A Bayesian Approach to Residual Host Cell DNA Safety Assessment
      Harry Yang and Jianchun Zhang
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 157-162; DOI: https://doi.org/10.5731/pdajpst.2015.006296

Z

  1. Zhang, Jianchun

    1. A Bayesian Approach to Residual Host Cell DNA Safety Assessment
      Harry Yang and Jianchun Zhang
      PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 157-162; DOI: https://doi.org/10.5731/pdajpst.2015.006296
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