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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: lassman m. Bioanalysis. 2024;16(9):307-364. doi: 10.1080/17576180.2024.2347153. Epub 2024 May 27. Bioanalysis. 2024. PMID: 38913185
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, Kellie J, Li W, Mehl J, Qian M, Qiu X, Sirtori FR, Rosenbaum AI, Sikorski T, Surapaneni S, Wang J, Wilson A, Zhang J, Xue Y, Post N, Huang Y, Goykhman D, Yuan L, Fang K, Casavant E, Chen L, Fu Y, Huang M, Ji A, Johnson J, Lassman M, Li J, Saad O, Sarvaiya H, Tao L, Wang Y, Zheng N, Dasgupta A, Abhari MR, Ishii-Watabe A, Saito Y, Mendes Fernandes DN, Bower J, Burns C, Carleton K, Cho SJ, Du X, Fjording M, Garofolo F, Kar S, Kavetska O, Kossary E, Lu Y, Mayer A, Palackal N, Salha D, Thomas E, Verhaeghe T, Vinter S, Wan K, Wang YM, Williams K, Woolf E, Yang L, Yang E, Bandukwala A, Hopper S, Maher K, Xu J, Brodsky E, Cludts I, Irwin C, Joseph J, Kirshner S, Manangeeswaran M, Maxfield K, Pedras-Vasconcelos J, Solstad T, Thacker S, Tounekti O, Verthelyi D, Wadhwa M, Wagner L, Yamamoto T, Zhang L, Zhou L. Szapacs M, et al. Among authors: lassman m. Bioanalysis. 2023 Aug;15(16):955-1016. doi: 10.4155/bio-2023-0167. Epub 2023 Aug 31. Bioanalysis. 2023. PMID: 37650500
High-throughput LC-MS method to investigate postprandial lipemia: considerations for future precision nutrition research.
Mucinski JM, Vena JE, Ramos-Roman MA, Lassman ME, Szuszkiewicz-Garcia M, McLaren DG, Previs SF, Shankar SS, Parks EJ. Mucinski JM, et al. Among authors: lassman me. Am J Physiol Endocrinol Metab. 2021 Apr 1;320(4):E702-E715. doi: 10.1152/ajpendo.00526.2020. Epub 2021 Feb 1. Am J Physiol Endocrinol Metab. 2021. PMID: 33522396 Free article. Clinical Trial.
A Microdose Cocktail to Evaluate Drug Interactions in Patients with Renal Impairment.
Tatosian DA, Yee KL, Zhang Z, Mostoller K, Paul E, Sutradhar S, Larson P, Chhibber A, Wen J, Wang YJ, Lassman M, Latham AH, Pang J, Crumley T, Gillespie A, Marricco NC, Marenco T, Murphy M, Lasseter KC, Marbury TC, Tweedie D, Chu X, Evers R, Stoch SA. Tatosian DA, et al. Among authors: lassman m. Clin Pharmacol Ther. 2021 Feb;109(2):403-415. doi: 10.1002/cpt.1998. Epub 2020 Oct 26. Clin Pharmacol Ther. 2021. PMID: 32705692 Clinical Trial.
Oncolytic Virotherapy Promotes Intratumoral T Cell Infiltration and Improves Anti-PD-1 Immunotherapy.
Ribas A, Dummer R, Puzanov I, VanderWalde A, Andtbacka RHI, Michielin O, Olszanski AJ, Malvehy J, Cebon J, Fernandez E, Kirkwood JM, Gajewski TF, Chen L, Gorski KS, Anderson AA, Diede SJ, Lassman ME, Gansert J, Hodi FS, Long GV. Ribas A, et al. Among authors: lassman me. Cell. 2018 Aug 9;174(4):1031-1032. doi: 10.1016/j.cell.2018.07.035. Cell. 2018. PMID: 30096300 Free article. No abstract available.
Oncolytic Virotherapy Promotes Intratumoral T Cell Infiltration and Improves Anti-PD-1 Immunotherapy.
Ribas A, Dummer R, Puzanov I, VanderWalde A, Andtbacka RHI, Michielin O, Olszanski AJ, Malvehy J, Cebon J, Fernandez E, Kirkwood JM, Gajewski TF, Chen L, Gorski KS, Anderson AA, Diede SJ, Lassman ME, Gansert J, Hodi FS, Long GV. Ribas A, et al. Among authors: lassman me. Cell. 2017 Sep 7;170(6):1109-1119.e10. doi: 10.1016/j.cell.2017.08.027. Cell. 2017. PMID: 28886381 Free PMC article. Clinical Trial.
Effects of CETP inhibition with anacetrapib on metabolism of VLDL-TG and plasma apolipoproteins C-II, C-III, and E.
Millar JS, Lassman ME, Thomas T, Ramakrishnan R, Jumes P, Dunbar RL, deGoma EM, Baer AL, Karmally W, Donovan DS, Rafeek H, Wagner JA, Holleran S, Obunike J, Liu Y, Aoujil S, Standiford T, Gutstein DE, Ginsberg HN, Rader DJ, Reyes-Soffer G. Millar JS, et al. Among authors: lassman me. J Lipid Res. 2017 Jun;58(6):1214-1220. doi: 10.1194/jlr.M074880. Epub 2017 Mar 17. J Lipid Res. 2017. PMID: 28314859 Free PMC article.
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