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Page 1
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).
Welink J, Yang E, Hughes N, Rago B, Woolf E, Sydor J, Coppola L, Ackermann B, Li W, Alley SC, Arnold M, Berger I, Briscoe C, Buonarati M, Bustard M, Cancilla M, Cho SJ, Duggan J, Fraier D, Garofolo F, Green R, Haidar S, Hittle L, Ishii-Watabe A, Islam R, Jenkins R, Jones B, Kadavil J, Kassim S, Kavetska O, Blaye OL, Lee A, Liu H, Mehl J, Lima Santos GM, Musuku A, Ramanathan R, Saito Y, Savoie N, Summerfield S, Surapaneni S, Szapacs M, Tampal N, Verhaeghe T, Vinter S, Whale E. Welink J, et al. Among authors: kavetska o. Bioanalysis. 2017 Nov;9(22):1807-1825. doi: 10.4155/bio-2017-4975. Epub 2017 Nov 17. Bioanalysis. 2017. PMID: 29148835
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).
Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Cape S, Dasgupta A, Fischer S, Haidar S, Hayes R, Kamerud J, Lima Santos GM, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H. Booth B, et al. Among authors: kavetska o. Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9. Bioanalysis. 2019. PMID: 31833782
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).
Kaur S, Alley SC, Szapacs M, Wilson A, Ciccimaro E, Su D, Henderson N, Chen L, Garofolo F, Hengel S, Jian W, Kellie JF, Lee A, Mehl J, Palandra J, Qiu H, Savoie N, Shakleya D, Staelens L, Sugimoto H, Sumner G, Welink J, Wheller R, Xue YJ, Zeng J, Zhang J, Zhou H, Wang J, Summerfield S, Kavetska O, Dillen L, Ramanathan R, Baratta M, Dasgupta A, Edmison A, Ferrari L, Fischer S, Fraier D, Haidar S, Heermeier K, James C, Ji A, Luo L, Lima Santos GM, Post N, Rosenbaum AI, Sporring S, Surapaneni S, Vinter S, Wan K, Woolf E, Kavetska O, Cho SJ, Kossary E, Prior S, Abhari MR, Soo C, Wang YM, Bandukwala A, Cherry E, Cludts I, Ghosh S, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Maxfield K, Pedras-Vasconcelos J, Saito Y, Smith D, Solstad T, Verthelyi D, Wadhwa M, Wagner L, Waxenecker G, Yan H, Zhang L. Kaur S, et al. Among authors: kavetska o. Bioanalysis. 2022 May;14(9):505-580. doi: 10.4155/bio-2022-0078. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578993
Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality.
Maass KF, Barfield MD, Ito M, James CA, Kavetska O, Kozinn M, Kumar P, Lepak M, Leuthold LA, Li W, Mikhailov D, Patel S, Perez NL, Jackson Rudd D, Vakkalagadda B, Williams TM, Zha J, Zhang X, Anderson MD. Maass KF, et al. Among authors: kavetska o. Clin Transl Sci. 2022 Dec;15(12):2785-2795. doi: 10.1111/cts.13411. Epub 2022 Oct 8. Clin Transl Sci. 2022. PMID: 36129129 Free PMC article.
Pharmacokinetics of Oral Nirmatrelvir/Ritonavir, a Protease Inhibitor for Treatment of COVID-19, in Subjects With Renal Impairment.
Toussi SS, Neutel JM, Navarro J, Preston RA, Shi H, Kavetska O, LaBadie RR, Binks M, Chan PLS, Demers N, Corrigan B, Damle B. Toussi SS, et al. Among authors: kavetska o. Clin Pharmacol Ther. 2022 Oct;112(4):892-900. doi: 10.1002/cpt.2688. Epub 2022 Jul 5. Clin Pharmacol Ther. 2022. PMID: 35712797 Free PMC article. Clinical Trial.
2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Baratta M, Jian W, Hengel S, Kaur S, Cunliffe J, Boer J, Hughes N, Kar S, Kellie J, Kim YJ, Lassman M, Mehl J, Morgan L, Palandra J, Sarvaiya H, Zeng J, Zheng N, Wang J, Yuan L, Ji A, Kochansky C, Tao L, Huang Y, Maes E, Barbero L, Contrepois K, Ferrari L, Fu Y, Johnson J, Jones B, Kansal M, Lu Y, Post N, Shen HH, Xue YY, Zhang YC, Biswas G, Cho SJ, Edmison A, Benson K, Abberley L, Azadeh M, Francis J, Garofolo F, Gupta S, Ivanova ID, Ishii-Watabe A, Karnik S, Kassim S, Kavetska O, Keller S, Kossary E, Li W, McCush F, Mendes DN, Abhari MR, Scheibner K, Sikorski T, Staack RF, Tabler E, Tang H, Wan K, Wang YM, Whale E, Yang L, Zimmer J, Bandukwala A, Du X, Kholmanskikh O, Gijsel SK, Wadhwa M, Xu J, Buoninfante A, Cludts I, Diebold S, Maxfield K, Mayer C, Pedras-Vasconcelos J, Abhari MR, Shubow S, Tanaka Y, Tounekti O, Verthelyi D, Wagner L. Baratta M, et al. Among authors: kavetska o. Bioanalysis. 2024;16(9):307-364. doi: 10.1080/17576180.2024.2347153. Epub 2024 May 27. Bioanalysis. 2024. PMID: 38913185
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