PDA Journal of Pharmaceutical Science and Technology: 69 (4)

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July/August 2015; Volume 69,Issue 4

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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

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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

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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

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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

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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