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A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation
Dennis Jenke, Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde and Jan Baeten
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 178-199; DOI: https://doi.org/10.5731/pdajpst.2021.012692