Olga Kavetska

Pharmacokinetics of Oral Nirmatrelvir/Ritonavir, a Protease Inhibitor for Treatment of <scp>COVID</scp>‐19, in Subjects With Renal Impairment

Sima S. Toussi, Joel M. Neutel, J. Navarro et al. · Clinical Pharmacology & Therapeutics · 2022 · 66 citations · Full text

Pharmacy, Pharmacokinetics, Pharmacology +17

Leveraging patient‐centric sampling for clinical drug development and decentralized clinical trials: Promise to reality

Katie F. Maass, Matthew Barfield, Mototsugu Ito et al. · Clinical and Translational Science · 2022 · 47 citations · Full text

Medicine, Pharmacokinetics, Pharmacology +15

2017 White Paper on Recent Issues in Bioanalysis: Aren’t Bmv Guidance/Guidelines ‘ <i>Scientific</i> ’? (Part 1 – LCMS: Small Molecules, Peptides and Small Molecule Biomarkers)

Jan Welink, Eric Yang, Nicola Hughes et al. · Bioanalysis · 2017 · 41 citations · Full text

Pharmacy, Biochemistry, Biomedical Sciences +15

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( <u>Part 2</u> – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

Brian Booth, Lauren Stevenson, Renuka Pillutla et al. · Bioanalysis · 2019 · 32 citations · Full text

Pharmacy, Biomedical Sciences, Biopharmaceutics +9

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 &amp; Rare Matrices; Regulatory Inputs ( <u>Part 1A</u> – Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC &amp; <u>Part 1B</u> - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene &amp; Cell Therapy and Vaccine)

Surinder Kaur, Stephen C. Alley, Matt Szapacs et al. · Bioanalysis · 2022 · 29 citations · Full text

Pharmacy, Biochemistry, Biomedical Sciences +15