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PDA Journal of Pharmaceutical Science and Technology|July 28, 2017
Complexing Agents and pH Influence on Chemical Durability of Type I Molded Glass ContainersAlberto Biavati, Michele Poncini, Arianna Ferrarini, et al.PDA Journal of Pharmaceutical Science and Technology|October 3, 2015
Strategies for Maximizing Successful Drug Substance Technology Transfer Using Engineering, Shake-Down, and Wet Test RunsSushil Abraham, David Bain, John Bowers, et al.PDA Journal of Pharmaceutical Science and Technology|December 15, 2015
Low Leachable Container System Consisting of a Polymer-Based Syringe with Chlorinated Isoprene Isobutene Rubber Plunger StopperHideaki Kiminami, Katsuyuki Takeuchi, Koji Nakamura, et al.PDA Journal of Pharmaceutical Science and Technology|November 22, 2017
Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design-A Worked-through Case StudyPhilippe Paolantonacci, Philippe Appourchaux, Béatrice Claudel, et al.PDA Journal of Pharmaceutical Science and Technology|December 16, 2017
Method Verification Requirements for an Advanced Imaging System for Microbial Plate Count EnumerationDavid Jones, Tony CundellPDA Journal of Pharmaceutical Science and Technology|December 16, 2017
A Risk Index and Data Display for Process Performance in the Pharmaceutical IndustryBert Gunter, Daniel Coleman, Aaron Goerke, et al.PDA Journal of Pharmaceutical Science and Technology|December 16, 2017
A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016Ana M C Santos, Mara S Doria, Luís Meirinhos-Soares, et al.PDA Journal of Pharmaceutical Science and Technology|September 21, 2017
Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral VialsJeffrey R Vieregg, Steven J Martin, Adam P Breeland, et al.PDA Journal of Pharmaceutical Science and Technology|February 16, 2018
Ozone Generation during High-Voltage Leak Detection: Fiction or Reality?Sophie Becker, Kai Reimers, Volker Bickert, et al.PDA Journal of Pharmaceutical Science and Technology|January 19, 2018
Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile FiltrationRoberto Menzel, Ina Pahl, Thomas Loewe, et al.Pageof 136