Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology
Link
http://link.springer.com/content/pdf/10.1007/s11095-019-2699-z.pdf
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3. FDA. S3A Guidance: Note for Guidance on Toxicokinetics: the assessment of systemic exposure in toxicity studies: focus on microsampling. May 2018.
4. Joyce AP, Wang M, Lawrence-Henderson R, Filliettaz C, Leung SS, Xu X, et al. One mouse, one pharmacokinetic profile: quantitative whole blood serial sampling for biotherapeutics. Pharm Res. 2014;31(7):1823–33.
5. Parker SL, Roberts JA, Lipman J, Wallis SC. Quantitative bioanalytical validation of fosfomycin in human whole blood with volumetric absorptive microsampling. Bioanalysis. 2015;7(19):2585–95.
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