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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

July/August 2015; Volume 69,Issue 4

Editorial

  • You have access
    Challenges in Maintaining Quality of Pharmaceutical Products
    Anurag S. Rathore
    PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 466; DOI: https://doi.org/10.5731/pdajpst.2015.01084

Letter to the Editor

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    Comment and Completion: Implementation of Parallelism Testing for Four-Parameter Logistic Model in Bioassays
    Perceval Sondag, Raphael Joie and Harry Yang
    PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 467-470; DOI: https://doi.org/10.5731/pdajpst.2015.01060

Commentary

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    Moving Forward towards Standardized Analytical Methods for Extractables and Leachables Profiling Studies
    Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 471-476; DOI: https://doi.org/10.5731/pdajpst.2015.01089

Research

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    Characterization of Propylene Glycol–Mitigated Freeze/Thaw Agglomeration of a Frozen Liquid nOMV Vaccine Formulation by Static Light Scattering and Micro-Flow Imaging
    Christopher D. Mensch, Harrison B. Davis and Jeffrey T. Blue
    PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 477-498; DOI: https://doi.org/10.5731/pdajpst.2015.01057
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    Quality Control Testing for Tracking Endotoxin-Producing Gram-Negative Bacteria during the Preparation of Polyvalent Snake Antivenom Immunoglobulin
    Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin and Hamdallah H. Zedan
    PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 499-510; DOI: https://doi.org/10.5731/pdajpst.2015.01058
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    Kinetic Modeling of Methionine Oxidation in Monoclonal Antibodies from Hydrogen Peroxide Spiking Studies
    Ada Hui, Xanthe M. Lam, Christopher Kuehl, Ulla Grauschopf and Y. John Wang
    PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 511-525; DOI: https://doi.org/10.5731/pdajpst.2015.01059

Case Studies

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    Evaluation of PDA Technical Report No 33. Statistical Testing Recommendations for a Rapid Microbiological Method Case Study
    Thomas Murphy, Julie Schwedock, Kham Nguyen, Anna Mills and David Jones
    PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 526-539; DOI: https://doi.org/10.5731/pdajpst.2015.01062
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    Reciprocal Translocation Observed in End-of-Production Cells of a Commercial CHO-Based Process
    Yolande Rouiller, Beate Kleuser, Emiliano Toso, Wolf Palinksy, Mara Rossi, Paola Rossatto, Davide Barberio and Hervé Broly
    PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 540-552; DOI: https://doi.org/10.5731/pdajpst.2015.01063

Commentary Special Section

  • Commentary

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      A Review of the Aging Process and Facilities Topic
      Maik W. Jornitz
      PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 553-556; DOI: https://doi.org/10.5731/pdajpst.2015.01061
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      Drug Shortages, Today and Tomorrow—An Industry Perspective
      Sandra Cha Sifferlen
      PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 557-561; DOI: https://doi.org/10.5731/pdajpst.2015.01066
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      Quality Culture vs. Cost of Quality—Quality Culture Is Understanding the Value, not Just the Price, of Quality
      Juergen Knoebel
      PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 562-565; DOI: https://doi.org/10.5731/pdajpst.2015.01067
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      Compounding Pharmacists, Skills and Knowledge, and the Role of Pharmacy Colleges
      Christopher J. Smalley
      PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 566-567; DOI: https://doi.org/10.5731/pdajpst.2015.01068
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 69 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 4
July/August 2015
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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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