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PDA Journal of Pharmaceutical Science and Technology|October 1, 2020
Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency AssaysThorsten Pflanzner, Yuanyuan Duan, Uyentrang N Bui, et al.PDA Journal of Pharmaceutical Science and Technology|June 19, 2017
Complexing agents and pH influence on chemical durability of type I moulded glass containersAlberto Biavati, Michele Poncini, Arianna Ferrarini, et al.PDA Journal of Pharmaceutical Science and Technology|February 16, 2022
Quantification and Stability Impact Assessment of Drop Stresses in Biologic Drug ProductsMahsa Siavashpouri, Christina M Bailey-Hytholt, Jean-Rene Authelin, et al.PDA Journal of Pharmaceutical Science and Technology|September 1, 1994
A new coincidence model for single particle counters, Part II: Advances and applicationsJ Z Knapp, A Lieberman, L R AbramsonPDA Journal of Pharmaceutical Science and Technology|November 16, 2023
Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification?Dennis JenkePDA Journal of Pharmaceutical Science and Technology|November 16, 2023
Worldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a VaccineThierry Gastineau, Cynthia Ban, Ana Basso, et al.PDA Journal of Pharmaceutical Science and Technology|September 15, 2023
Excipient and Packaging Material Impact on Glass and Polymer-Based Prefilled Syringe FunctionalityLiang Fang, Marissa RasePDA Journal of Pharmaceutical Science and Technology|October 17, 2023
Creating an Assessment Indicator of Quality Culture Development in the Generic Pharmaceutical Industry in JapanShiho Takahashi, Tetsuhito Takarada, Riho Kitamura, et al.PDA Journal of Pharmaceutical Science and Technology|October 17, 2023
Challenges Associated with Biological Safety Assessments for Drug-Device Combination ProductsCheryl L M Stults, Diane Harper, Doris ZanePDA Journal of Pharmaceutical Science and Technology|March 20, 2003
Use of the hazard analysis and critical control points (HACCP) risk assessment on a medical device for parenteral applicationMichael Jahnke, Klaus-Dieter KühnPageof 136