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2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 - Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis).
Fandozzi C, Evans C, Wilson A, Su D, Anderson M, Clausen V, Dillen L, Garofolo F, Holliman C, Nickbarg E, Olah T, Ramanathan R, Zhang H, Kaur S, Pillutla R, Yu H, Bateman K, Donato LD, Hengel S, Jian W, Jones B, Kellie J, Lee A, Palandra J, Savoie N, Shipkova P, Spitz S, Su D, Szapacs M, Wang J, Wright K, Zeng J. Fandozzi C, et al. Among authors: clausen v. Bioanalysis. 2019 Nov;11(22):2029-2048. doi: 10.4155/bio-2019-0260. Epub 2019 Dec 6. Bioanalysis. 2019. PMID: 31808716 Free article.
Nonclinical Pharmacokinetics and Absorption, Distribution, Metabolism, and Excretion of Givosiran, the First Approved N-Acetylgalactosamine-Conjugated RNA Interference Therapeutic.
Li J, Liu J, Zhang X, Clausen V, Tran C, Arciprete M, Wang Q, Rocca C, Guan LH, Zhang G, Najarian D, Xu Y, Smith P, Wu JT, Chong S. Li J, et al. Among authors: clausen v. Drug Metab Dispos. 2021 Jul;49(7):572-580. doi: 10.1124/dmd.121.000381. Epub 2021 May 3. Drug Metab Dispos. 2021. PMID: 33941543
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Hersey S, Keller S, Mathews J, King L, Bandukwala A, Berisha F, Birchler M, Bower J, Clausen V, Duarte J, Garofolo F, Hopper S, Kar S, Mabrouk O, Marshall JC, McGuire K, Naughton M, Saito Y, Schuhmann I, Sperinde G, Teixeira P, Vitaliti A, Wang YM, Wnek R, Zhang Y, Spitz S, Decman V, Eck S, Estevam J, Goihberg P, Alcaide EG, Gonneau C, Hedrick MN, Hopkins G, Junker F, Nuti S, Sommer U, Standifer N, Stevens C, Stevens E, Hendricks C, Wadhwa M, Torri A, Ma M, Harris S, Kumar S, Partridge MA, Caiazzo T, Chilewski S, Cludts I, Coble K, Gorovits B, Grimaldi C, Jordan G, Kamerud J, Leary B, Liang M, Lim H, Mayer A, O'Connor E, Palackal N, Poetzl J, Prior S, Abhari MR, Savoie N, Soo C, Ware M, Wu B, Xu Y, Yang TY, Zoghbi J. Hersey S, et al. Among authors: clausen v. Bioanalysis. 2022 May;14(10):627-692. doi: 10.4155/bio-2022-0080. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578974 Free article.
Harnessing a physiologic mechanism for siRNA delivery with mimetic lipoprotein particles.
Nakayama T, Butler JS, Sehgal A, Severgnini M, Racie T, Sharman J, Ding F, Morskaya SS, Brodsky J, Tchangov L, Kosovrasti V, Meys M, Nechev L, Wang G, Peng CG, Fang Y, Maier M, Rajeev KG, Li R, Hettinger J, Barros S, Clausen V, Zhang X, Wang Q, Hutabarat R, Dokholyan NV, Wolfrum C, Manoharan M, Kotelianski V, Stoffel M, Sah DW. Nakayama T, et al. Among authors: clausen v. Mol Ther. 2012 Aug;20(8):1582-9. doi: 10.1038/mt.2012.33. Epub 2012 Jun 5. Mol Ther. 2012. PMID: 22850721 Free PMC article.
Pharmacokinetic and Pharmacodynamic Properties of Cemdisiran, an RNAi Therapeutic Targeting Complement Component 5, in Healthy Subjects and Patients with Paroxysmal Nocturnal Hemoglobinuria.
Badri P, Jiang X, Borodovsky A, Najafian N, Kim J, Clausen VA, Goel V, Habtemariam B, Robbie GJ. Badri P, et al. Among authors: clausen va. Clin Pharmacokinet. 2021 Mar;60(3):365-378. doi: 10.1007/s40262-020-00940-9. Clin Pharmacokinet. 2021. PMID: 33047216 Free PMC article. Clinical Trial.
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