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1.
Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation.
Clin Pharmacol Ther
; 115(1): 42-51, 2024 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-37597239
2.
Using Mitra sampling to support first-in-human pharmacokinetic evaluations for PF-07059013.
Bioanalysis
; 15(17): 1083-1094, 2023 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-37584365
3.
Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device.
Bioanalysis
; 14(20): 1305-1315, 2022 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-36541270
4.
Pharmacokinetics of Oral Nirmatrelvir/Ritonavir, a Protease Inhibitor for Treatment of COVID-19, in Subjects With Renal Impairment.
Clin Pharmacol Ther
; 112(4): 892-900, 2022 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-35712797
5.
Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality.
Clin Transl Sci
; 15(12): 2785-2795, 2022 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-36129129
6.
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 14(9): 505-580, 2022 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578993
7.
Validation of enantioseparation and quantitation of an active metabolite of abrocitinib in human plasma.
Bioanalysis
; 13(19): 1477-1486, 2021 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-34601943
8.
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Bioanalysis
; 11(23): 2099-2132, 2019 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-31833782
9.
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).
Bioanalysis
; 9(22): 1807-1825, 2017 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-29148835
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