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ICH M10 Bioanalytical Method Validation Guideline-1 year Later.
AAPS J. 2024 Sep 12;26(5):103. doi: 10.1208/s12248-024-00974-y.
AAPS J. 2024.
PMID: 39266900
Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group.
Li W, Vazvaei-Smith F, Dear G, Boer J, Cuyckens F, Fraier D, Liang Y, Lu D, Mangus H, Moliner P, Pedersen ML, Romeo AA, Spracklin DK, Wagner DS, Winter S, Xu XS.
Li W, et al. Among authors: vazvaei smith f.
Clin Pharmacol Ther. 2024 May;115(5):939-953. doi: 10.1002/cpt.3144. Epub 2024 Mar 12.
Clin Pharmacol Ther. 2024.
PMID: 38073140
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Neutralization Activity of Anti-drug Antibodies Against a Biotherapeutic Can Be Predicted from a Comprehensive Pharmacokinetics, Pharmacodynamics, and Anti-drug Antibody Data Analysis.
Xu W, Maas B, Roadcap B, Swarup A, Steinmetz T, Luo L, Ichetovkin M, Wood S, Vazvaei-Smith F, Lee AW, Vora K, Helmy R.
Xu W, et al. Among authors: vazvaei smith f.
AAPS J. 2022 Sep 27;24(6):102. doi: 10.1208/s12248-022-00753-7.
AAPS J. 2022.
PMID: 36167856
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Biomarker Assay Validation by Mass Spectrometry.
Fernández-Metzler C, Ackermann B, Garofolo F, Arnold ME, DeSilva B, Gu H, Laterza O, Mao Y, Rose M, Vazvaei-Smith F, Steenwyk R.
Fernández-Metzler C, et al. Among authors: vazvaei smith f.
AAPS J. 2022 May 9;24(3):66. doi: 10.1208/s12248-022-00707-z.
AAPS J. 2022.
PMID: 35534647
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