ICH Q3D

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Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel

PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379
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How One Might Experimentally Determine if Container Closure Systems and Their Components and Materials of Construction Contribute Elemental Impurities To Packaged Pharmaceutical Drug Products
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 181-190; DOI: https://doi.org/10.5731/pdajpst.2018.008938
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Assessment of Extractable Elements from Elastomers
Diane Paskiet, Crystal Kraft, Erica Tullo, Jeff Hunter and Diego Zurbriggen

PDA Journal of Pharmaceutical Science and Technology January 2019, 73 (1) 83-91; DOI: https://doi.org/10.5731/pdajpst.2017.008193

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