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PDA Journal of Pharmaceutical Science and Technology|June 28, 2024
Clarifications on the Intended Use of USP Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsEdward C Tidswell, Radhakrishna S Tirumalai, Deborah D GrossPDA Journal of Pharmaceutical Science and Technology|January 18, 2026
Proactive replacement in aseptic manufacturing: A Health Index + Weibull/KaplanâMeier frameworkSaiVijay Thattukolla, SaiVinay ThattukollaPDA Journal of Pharmaceutical Science and Technology|January 30, 2026
Neural Network Prediction of Response Factors for Extractables and Leachables in Pharmaceuticals and Medical DevicesYuanlin Deng, Anthony Grice, Michael Louis, et al.PDA Journal of Pharmaceutical Science and Technology|December 26, 2024
Correlating GC/MS Relative Response Factors to Analyte's Physicochemical and Chromatographic Properties to Facilitate the Quantitation of Organic Extractables and Leachables in Non-Targeted Analysis (NTA). Concepts and Empirical ConsiderationsDennis Jenke, Piet Christiaens, Philippe Verlinde, et al.PDA Journal of Pharmaceutical Science and Technology|December 27, 2024
Definition of Particle Visibility Threshold in Parenteral Drug Products-Towards Standardization of Visual Inspection Operator QualificationFilip M Fedorowicz, Andreas Zerr, Roman Mathaes, et al.PDA Journal of Pharmaceutical Science and Technology|November 16, 2023
A Method to Investigate Sterilization Processes and the Bacterial Inactivation Resolved in Time and SpaceManuel Feurhuber, Thomas Taupitz, Frank Mueller, et al.PDA Journal of Pharmaceutical Science and Technology|July 14, 2023
Laser Measurement and Numerical Simulation of Elastomer Stopper Motion during High-Altitude Shipping of Pharmaceutical SyringesKirk Roffi, Naveed Siddiqui, Samantha Portelli, et al.PDA Journal of Pharmaceutical Science and Technology|August 14, 2023
Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 1: Experimental Details and Modeling Experimental ResultsPeter V Mercea, Manfred Ossberger, Regina Wyrwich, et al.PDA Journal of Pharmaceutical Science and Technology|August 14, 2023
Stopper Movement and Headspace (Air Bubble Size) Limitations for 2.25 mL Prefilled SyringeChristina Evans, Yusuf Oni, Daniel Paniagua, et al.PDA Journal of Pharmaceutical Science and Technology|August 14, 2023
Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 2: Conservative Diffusion and Partition Coefficient DeterminationsPeter V Mercea, Manfred Ossberger, Regina Wyrwich, et al.Pageof 136