Table of Contents

March/April 2017; Volume 71,Issue 2

A

  1. Agarabi, Cyrus

    1. Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
      Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2016.007054

B

  1. Baca, Manuel

    1. Characterizing the Overall Derivatization of Conjugated Oligomeric Proteins
      Michaela Wendeler, Wei Zhao, Christopher Thompson, Manuel Baca, Dhanesh Gadre, Xiangyang Wang and Harry Yang
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 115-126; DOI: https://doi.org/10.5731/pdajpst.2016.006510

  2. Brorson, Kurt

    1. Emerging Technology as a Key Enabler for Modernizing Pharmaceutical Manufacturing
      Sau (Larry) Lee and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 66-67; DOI: https://doi.org/10.5731/pdajpst.2017.001100
    2. Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
      Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2016.007054

  3. Brown, Helen

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

  4. Brown, Matthew

    1. Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
      Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2016.007054

  5. Busse, Ursula

    1. PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
      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, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492

C

  1. Castner, James

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

  2. Chizhikov, Vladimir

    1. Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
      Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2016.007054

  3. Colao, Marcello

    1. PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
      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, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492

D

  1. Dabrazhynetskaya, Alena

    1. Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
      Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2016.007054

  2. Dreher, Sascha

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

E

  1. Edwards, Julia

    1. PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
      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, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492

  2. Egert, Thomas

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

F

  1. Faya, Paul

    1. A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation
      Paul Faya, James D. Stamey and John W. Seaman
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 88-98; DOI: https://doi.org/10.5731/pdajpst.2016.006981

  2. Feinberg, Tom

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

G

  1. Gadre, Dhanesh

    1. Characterizing the Overall Derivatization of Conjugated Oligomeric Proteins
      Michaela Wendeler, Wei Zhao, Christopher Thompson, Manuel Baca, Dhanesh Gadre, Xiangyang Wang and Harry Yang
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 115-126; DOI: https://doi.org/10.5731/pdajpst.2016.006510

  2. Goecks, Jeremy

    1. Biocompute Objects—A Step towards Evaluation and Validation of Biomedical Scientific Computations
      Vahan Simonyan, Jeremy Goecks and Raja Mazumder
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 136-146; DOI: https://doi.org/10.5731/pdajpst.2016.006734

H

  1. Hemminger, Markus

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

  2. Hendricker, Alan

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

  3. Hilario, Eric C.

    1. An Improved Method of Predicting Extinction Coefficients for the Determination of Protein Concentration
      Eric C. Hilario, Alan Stern, Charlie H. Wang, Yenny W. Vargas, Charles J. Morgan, Trevor E. Swartz and Thomas W. Patapoff
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 127-135; DOI: https://doi.org/10.5731/pdajpst.2016.007120

  4. Holcomb, Frank

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

  5. Houston, Christopher

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

  6. Hunt, Desmond G.

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

J

  1. Jenke, Dennis

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

  2. Johnson, Sarah

    1. Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
      Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2016.007054

  3. Jornitz, Maik

    1. PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
      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, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492

K

  1. Kossinna, Juergen

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

L

  1. Lee, Sau (Larry)

    1. Emerging Technology as a Key Enabler for Modernizing Pharmaceutical Manufacturing
      Sau (Larry) Lee and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 66-67; DOI: https://doi.org/10.5731/pdajpst.2017.001100

  2. Lute, Scott

    1. Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
      Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2016.007054

  3. Lynch, Michael

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

M

  1. Mahler, Hanns-Christian

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

  2. Markovic, Ingrid

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

  3. Mathaes, Roman

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

  4. Mazumder, Raja

    1. Biocompute Objects—A Step towards Evaluation and Validation of Biomedical Scientific Computations
      Vahan Simonyan, Jeremy Goecks and Raja Mazumder
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 136-146; DOI: https://doi.org/10.5731/pdajpst.2016.006734

  5. Mellman, James

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

  6. Morgan, Charles J.

    1. An Improved Method of Predicting Extinction Coefficients for the Determination of Protein Concentration
      Eric C. Hilario, Alan Stern, Charlie H. Wang, Yenny W. Vargas, Charles J. Morgan, Trevor E. Swartz and Thomas W. Patapoff
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 127-135; DOI: https://doi.org/10.5731/pdajpst.2016.007120

  7. Munk, Morten

    1. PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
      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, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492

N

  1. Nicholas, Kumudini

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

  2. Nieto, Alejandra

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

  3. Norwood, Daniel L.

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

P

  1. Paskiet, Diane

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

  2. Patapoff, Thomas W.

    1. An Improved Method of Predicting Extinction Coefficients for the Determination of Protein Concentration
      Eric C. Hilario, Alan Stern, Charlie H. Wang, Yenny W. Vargas, Charles J. Morgan, Trevor E. Swartz and Thomas W. Patapoff
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 127-135; DOI: https://doi.org/10.5731/pdajpst.2016.007120

R

  1. Ramnarine, Emma

    1. PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
      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, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492

  2. Roehl, Holger

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

  3. Ruberto, Michael

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

S

  1. Schaar, Matthias

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

  2. Schmitting, Franz

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

  3. Seaman, John W.

    1. A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation
      Paul Faya, James D. Stamey and John W. Seaman
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 88-98; DOI: https://doi.org/10.5731/pdajpst.2016.006981

  4. Seymour, Melissa

    1. PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
      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, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492

  5. Simianu, Mihaela

    1. PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
      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, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492

  6. Simonyan, Vahan

    1. Biocompute Objects—A Step towards Evaluation and Validation of Biomedical Scientific Computations
      Vahan Simonyan, Jeremy Goecks and Raja Mazumder
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 136-146; DOI: https://doi.org/10.5731/pdajpst.2016.006734

  7. Skeens, Lisa

    1. PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
      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, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492

  8. Smith, Edward J.

    1. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
      Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229

  9. Stamey, James D.

    1. A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation
      Paul Faya, James D. Stamey and John W. Seaman
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 88-98; DOI: https://doi.org/10.5731/pdajpst.2016.006981

  10. Stern, Alan

    1. An Improved Method of Predicting Extinction Coefficients for the Determination of Protein Concentration
      Eric C. Hilario, Alan Stern, Charlie H. Wang, Yenny W. Vargas, Charles J. Morgan, Trevor E. Swartz and Thomas W. Patapoff
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 127-135; DOI: https://doi.org/10.5731/pdajpst.2016.007120

  11. Swartz, Trevor E.

    1. An Improved Method of Predicting Extinction Coefficients for the Determination of Protein Concentration
      Eric C. Hilario, Alan Stern, Charlie H. Wang, Yenny W. Vargas, Charles J. Morgan, Trevor E. Swartz and Thomas W. Patapoff
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 127-135; DOI: https://doi.org/10.5731/pdajpst.2016.007120

T

  1. Thompson, Christopher

    1. Characterizing the Overall Derivatization of Conjugated Oligomeric Proteins
      Michaela Wendeler, Wei Zhao, Christopher Thompson, Manuel Baca, Dhanesh Gadre, Xiangyang Wang and Harry Yang
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 115-126; DOI: https://doi.org/10.5731/pdajpst.2016.006510

V

  1. Vargas, Yenny W.

    1. An Improved Method of Predicting Extinction Coefficients for the Determination of Protein Concentration
      Eric C. Hilario, Alan Stern, Charlie H. Wang, Yenny W. Vargas, Charles J. Morgan, Trevor E. Swartz and Thomas W. Patapoff
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 127-135; DOI: https://doi.org/10.5731/pdajpst.2016.007120

  2. Vinther, Anders

    1. PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
      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, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492

W

  1. Wagner, Daniel

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

  2. Wang, Charlie H.

    1. An Improved Method of Predicting Extinction Coefficients for the Determination of Protein Concentration
      Eric C. Hilario, Alan Stern, Charlie H. Wang, Yenny W. Vargas, Charles J. Morgan, Trevor E. Swartz and Thomas W. Patapoff
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 127-135; DOI: https://doi.org/10.5731/pdajpst.2016.007120

  3. Wang, Julie

    1. Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
      Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2016.007054

  4. Wang, Xiangyang

    1. Characterizing the Overall Derivatization of Conjugated Oligomeric Proteins
      Michaela Wendeler, Wei Zhao, Christopher Thompson, Manuel Baca, Dhanesh Gadre, Xiangyang Wang and Harry Yang
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 115-126; DOI: https://doi.org/10.5731/pdajpst.2016.006510

  5. Wendeler, Michaela

    1. Characterizing the Overall Derivatization of Conjugated Oligomeric Proteins
      Michaela Wendeler, Wei Zhao, Christopher Thompson, Manuel Baca, Dhanesh Gadre, Xiangyang Wang and Harry Yang
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 115-126; DOI: https://doi.org/10.5731/pdajpst.2016.006510

  6. Wuchner, Klaus

    1. Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
      Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999

Y

  1. Yang, Harry

    1. Characterizing the Overall Derivatization of Conjugated Oligomeric Proteins
      Michaela Wendeler, Wei Zhao, Christopher Thompson, Manuel Baca, Dhanesh Gadre, Xiangyang Wang and Harry Yang
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 115-126; DOI: https://doi.org/10.5731/pdajpst.2016.006510

Z

  1. Zhao, Wei

    1. Characterizing the Overall Derivatization of Conjugated Oligomeric Proteins
      Michaela Wendeler, Wei Zhao, Christopher Thompson, Manuel Baca, Dhanesh Gadre, Xiangyang Wang and Harry Yang
      PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 115-126; DOI: https://doi.org/10.5731/pdajpst.2016.006510
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