Index by Author

Research

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  Qualification of a Quantitative Method for Monitoring Aspartate Isomerization of a Monoclonal Antibody by Focused Peptide Mapping

  Mingyan Cao, Wenjun (David) Mo, Anthony Shannon, Ziping Wei, Michael Washabaugh and Patricia Cash

  PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 490-507; DOI: https://doi.org/10.5731/pdajpst.2015.006239
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  The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes

  Tobias Werk, Imke S. Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler and Mathias Hafner

  PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 508-522; DOI: https://doi.org/10.5731/pdajpst.2015.006387
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  Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry

  Anthony B. Ciavarella, Mansoor A. Khan, Abhay Gupta and Patrick J. Faustino

  PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 523-532; DOI: https://doi.org/10.5731/pdajpst.2015.006411
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  A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization

  Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R. Patel

  PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 533-546; DOI: https://doi.org/10.5731/pdajpst.2015.006338
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  On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation

  Harry Yang, Steven Novick and Richard K. Burdick

  PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 547-559; DOI: https://doi.org/10.5731/pdajpst.2016.006551