Potency

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Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management
Cristiana Campa, Didier ClÉnet, Jane Halpern, Lyne Le Palaire, Mahesh Krishnan, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt and Sabrina Restrepo

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 735-750; DOI: https://doi.org/10.5731/pdajpst.2024.012976
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Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis
Patricia Parris, Geraldine Whelan, Anders Burild, Jessica Whritenour, Uma Bruen, Joel Bercu, Courtney Callis, Martyn L. Chilton, Jessica Graham, Esther Johann, Candice Johnson, Troy Griffin, Martin Kohan, Elizabeth A. Martin, Melisa Masuda-Herrera, Brad Stanard, Maureen T. Cruz and Lee Nagao

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 399-444; DOI: https://doi.org/10.5731/pdajpst.2022.012811
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Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman and Martina Kron

PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 173-187; DOI: https://doi.org/10.5731/pdajpst.2020.012096

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