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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Sumner G, Keller S, Huleatt J, Staack RF, Wagner L, Azadeh M, Bandukwala A, Cao L, Du X, Salinas GF, Garofolo F, Harris S, Hopper S, Irwin C, Ji Q, Joseph J, King L, Kinhikar A, Lu Y, Luo R, Mabrouk O, Malvaux L, Marshall JC, McGuire K, Mikol V, Neely R, Qiu X, Saito Y, Salaun B, Scully I, Smeraglia J, Solstad T, Stoop J, Tang H, Teixeira P, Wang Y, Wright M, Mendez L, Beaver C, Eacret J, Au-Yeung A, Decman V, Dessy F, Eck S, Goihberg P, Alcaide EG, Gonneau C, Grugan K, Hedrick MN, Kar S, Sehra S, Stevens E, Stevens C, Sun Y, McCush F, Williams L, Fischer S, Wu B, Jordan G, Burns C, Cludts I, Coble K, Grimaldi C, Henderson N, Joyce A, Lotz G, Lu Y, Luo L, Neff F, Sperinde G, Stubenrauch KG, Wang Y, Ware M, Xu W. Sumner G, et al. Among authors: grimaldi c. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363 Free article.
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Mora J, Palmer R, Wagner L, Wu B, Partridge M, Meena, Sonderegger I, Smeraglia J, Bivi N, Dakappagari N, Diebold S, Garofolo F, Grimaldi C, Kalina W, Kamerud J, Kar S, Marshall JC, Mayer C, Melton A, Merdek K, Nolan K, Picard S, Shao W, Seitzer J, Tanaka Y, Tounekti O, Vigil A, Walravens K, Xu J, Xu W, Xu Y, Yang L, Zhu L, Verthelyi D, Kubiak RJ, Coble K, Gupta S, Abhari MR, Richards S, Song Y, Ullmann M, Calderon B, Cludts I, Gunn GR, Gupta S, Ishii-Watabe A, Manangeeswaran M, Maxfield K, McCush F, O'Day C, Peng K, Poetzl J, Rasamoelisolo M, Saad OM, Scheibner K, Shubow S, Song S, Thacker S. Mora J, et al. Among authors: grimaldi c. Bioanalysis. 2024 Apr;16(7):77-119. doi: 10.4155/bio-2024-0024. Epub 2024 Feb 22. Bioanalysis. 2024. PMID: 38389403 Free article.
Therapeutic Protein Drug Interactions: A White Paper From the International Consortium for Innovation and Quality in Pharmaceutical Development.
Coutant DE, Boulton DW, Dahal UP, Deslandes A, Grimaldi C, Pereira JNS, Säll C, Sarvaiya H, Schiller H, Tai G, Umehara K, Yuan Y, Dallas S. Coutant DE, et al. Among authors: grimaldi c. Clin Pharmacol Ther. 2023 Jun;113(6):1185-1198. doi: 10.1002/cpt.2814. Epub 2023 Jan 17. Clin Pharmacol Ther. 2023. PMID: 36477720 Review.
Current nonclinical approaches for immune assessments of immuno-oncology biotherapeutics.
Grimaldi C, Ibraghimov A, Kiessling A, Rattel B, Ji C, Fuller CL, Brennan FR, Regenass-Lechner F, Shenton J, Price KD, Piché MS, Steeves MA, Prell R, Dudal S, Kronenberg S, Freebern W, Blanset D. Grimaldi C, et al. Drug Discov Today. 2023 Feb;28(2):103440. doi: 10.1016/j.drudis.2022.103440. Epub 2022 Nov 12. Drug Discov Today. 2023. PMID: 36375739 Free article. Review.
Nonclinical pharmacokinetics and biodistribution of VSV-GP using methods to decouple input drug disposition and viral replication.
Dambra R, Matter A, Graca K, Akhand SS, Mehta S, Bell-Cohn A, Swenson JM, Abid S, Xin D, Lewis C, Coyle L, Wang M, Bunosso K, Maugiri M, Ruiz R, Cirillo CM, Fogal B, Grimaldi C, Vigil A, Wood C, Ashour J. Dambra R, et al. Among authors: grimaldi c. Mol Ther Methods Clin Dev. 2022 Dec 28;28:190-207. doi: 10.1016/j.omtm.2022.12.013. eCollection 2023 Mar 9. Mol Ther Methods Clin Dev. 2022. PMID: 36700123 Free PMC article.
Editorial: Update in pediatric gynecology.
Perelli F, Grimaldi C, Candiani M, Masieri L, Mantovani A. Perelli F, et al. Among authors: grimaldi c. Front Surg. 2024 Mar 21;11:1391435. doi: 10.3389/fsurg.2024.1391435. eCollection 2024. Front Surg. 2024. PMID: 38577254 Free PMC article. No abstract available.
MIB Guides: Measuring the Immunoreactivity of Radioimmunoconjugates.
Delaney S, Grimaldi C, Houghton JL, Zeglis BM. Delaney S, et al. Among authors: grimaldi c. Mol Imaging Biol. 2024 Apr;26(2):213-221. doi: 10.1007/s11307-024-01898-x. Epub 2024 Mar 6. Mol Imaging Biol. 2024. PMID: 38446323 Free PMC article.
234 results