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2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, Keller S, Purushothama S, Gorovits B, Litwin V, Stebbins C, Marini J, Beaver C, Sperinde G, Siguenza P, Staack RF, Qiu Y, Amaravadi L, Amur S, Fleener CA, Baltrukonis D, Catlett I, Cherry E, Chung S, Cludts I, Donato LD, Fischer S, Fraser S, Garofolo F, Green C, Gunn G, Haidar S, Haulenbeek J, Henderson N, Hopper S, Ishii-Watabe A, Islam R, Janelsins B, Jawa V, Kakkanaiah V, Kamondi S, Kolaitis G, Kubiak RJ, Kumar S, Kurki P, Liang M, Liu P, Maxfield K, Myler H, Palackal N, Palmer R, Pedras-Vasconcelos J, Piccoli S, Rhyne P, Saito Y, Savoie N, Schick E, Schweighardt B, Shih J, Song A, Sriraman P, Staelens L, Sumner G, Sun Y, Ullmann M, Verthelyi D, Wadhwa M, Wang YM, Xu Y, Yan H, Yang TY, Zeng R. Stevenson L, et al. Among authors: marini j. Bioanalysis. 2018 Dec;10(24):1973-2001. doi: 10.4155/bio-2018-0287. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488726 Free article. Review.
Mini Focus: bioanalysis of biosimilars.
Amaravadi L, Marini J. Amaravadi L, et al. Among authors: marini j. Bioanalysis. 2013 Mar;5(5):515-6. doi: 10.4155/bio.13.26. Bioanalysis. 2013. PMID: 23425264 Free article. No abstract available.
2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.
Savoie N, Garofolo F, van Amsterdam P, Bansal S, Beaver C, Bedford P, Booth BP, Evans C, Jemal M, Lefebvre M, Lopes de Silva AL, Lowes S, Marini JC, Massé R, Mawer L, Ormsby E, Rocci ML Jr, Viswanathan C, Wakelin-Smith J, Welink J, White JT, Woolf E. Savoie N, et al. Among authors: marini jc. Bioanalysis. 2010 Dec;2(12):1945-60. doi: 10.4155/bio.10.164. Bioanalysis. 2010. PMID: 21110739 Free article.
Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments.
Marini JC, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher RR. Marini JC, et al. AAPS J. 2014 Nov;16(6):1149-58. doi: 10.1208/s12248-014-9669-5. Epub 2014 Oct 3. AAPS J. 2014. PMID: 25277165 Free PMC article.
Erratum to: Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments.
Marini JC, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher RR. Marini JC, et al. AAPS J. 2017 May;19(3):883. doi: 10.1208/s12248-017-0074-8. AAPS J. 2017. PMID: 28374318 No abstract available.
Tiered approaches to chromatographic bioanalytical method performance evaluation: recommendation for best practices and harmonization from the Global Bioanalysis Consortium harmonization team.
Lowes S, Hucker R, Jemal M, Marini JC, Rezende VM, Shoup R, Singhal P, Timmerman P, Yoneyama T, Weng N, Zimmer D. Lowes S, et al. Among authors: marini jc. AAPS J. 2015 Jan;17(1):17-23. doi: 10.1208/s12248-014-9656-x. Epub 2014 Oct 23. AAPS J. 2015. PMID: 25338740 Free PMC article.
Effects of mechanical ventilation on the interstitial extracellular matrix in healthy lungs and lungs affected by acute respiratory distress syndrome: a narrative review.
Al-Husinat L, Azzam S, Al Sharie S, Al Sharie AH, Battaglini D, Robba C, Marini JJ, Thornton LT, Cruz FF, Silva PL, Rocco PRM. Al-Husinat L, et al. Among authors: marini jj. Crit Care. 2024 May 15;28(1):165. doi: 10.1186/s13054-024-04942-y. Crit Care. 2024. PMID: 38750543 Free PMC article. Review.
739 results