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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

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

Research

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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

Technology/Application

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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

Commentary

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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

PDA Papers

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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
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 71 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 2
March/April 2017
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  • A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
  • A Commentary on Several Study Design Considerations Pertaining to the Screening of Substances Extracted and/or Leached from Pharmaceutical Contact Materials
  • Low-Volume Aseptic Filling Using a Linear Peristaltic Pump
  • The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
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