PDA Journal of Pharmaceutical Science and Technology: 71 (2)

March/April 2017; Volume 71,Issue 2

Editorial

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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

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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
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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
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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

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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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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

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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
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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

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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