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517 results

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Page 1
Recommendations on qPCR/ddPCR assay validation by GCC.
Wissel M, Poirier M, Satterwhite C, Lin J, Islam R, Zimmer J, Khadang A, Zemo J, Lester T, Fjording M, Hays A, Hughes N, Garofolo F, Guilbaud R, Groeber E, Renfrew H, Colletti K, Yu M, Lin J, Fang X, Shah S, Garofolo W, Kar S, Hayes R, Pirro J, Kane C, Luna M, Xu A, Cape S, O'Dell M, Wheller R, Ritzen H, Vance J, Farley E, Matys K, Tabler E, Mylott W, Yuan M, Karnik S, Voelker T, DuBey I, Williard C, Shi J, Yamashita J. Wissel M, et al. Bioanalysis. 2022 Jun;14(12):853-863. doi: 10.4155/bio-2022-0109. Epub 2022 Jun 15. Bioanalysis. 2022. PMID: 35703321
Exome and genome sequencing for pediatric patients with congenital anomalies or intellectual disability: an evidence-based clinical guideline of the American College of Medical Genetics and Genomics (ACMG).
Manickam K, McClain MR, Demmer LA, Biswas S, Kearney HM, Malinowski J, Massingham LJ, Miller D, Yu TW, Hisama FM; ACMG Board of Directors. Manickam K, et al. Genet Med. 2021 Nov;23(11):2029-2037. doi: 10.1038/s41436-021-01242-6. Epub 2021 Jul 1. Genet Med. 2021. PMID: 34211152 Free article.
Authors' Response.
Naavaal S, Demopoulos CA, Kelly A, Tranby E, Frantsve-Hawley J. Naavaal S, et al. J Am Dent Assoc. 2023 Jul;154(7):549-550. doi: 10.1016/j.adaj.2023.05.005. Epub 2023 May 24. J Am Dent Assoc. 2023. PMID: 37227381 No abstract available.
COVID-19: Post-recovery Manifestations.
Shaikh S, Siddiqi Z, Ukachukwu C, Mehkari Z, Khan S, Pamurthy K, Jahan F, Brown A. Shaikh S, et al. Cureus. 2023 Mar 29;15(3):e36886. doi: 10.7759/cureus.36886. eCollection 2023 Mar. Cureus. 2023. PMID: 37128534 Free PMC article.
Flow cytometry and pharmacokinetics.
Lang K, Matys K, Bennett P, Kakkanaiah VN. Lang K, et al. Bioanalysis. 2021 Nov;13(21):1645-1651. doi: 10.4155/bio-2021-0140. Epub 2021 Oct 18. Bioanalysis. 2021. PMID: 34657485 Review.
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development.
Hays A, Wissel M, Colletti K, Soon R, Azadeh M, Smith J, Doddareddy R, Chalfant M, Adamowicz W, Ramaswamy SS, Dholakiya SL, Guelman S, Gullick B, Durham J, Rennier K, Nagilla P, Muruganandham A, Diaz M, Tierney C, John K, Valentine J, Lockman T, Liu HY, Moritz B, Ouedraogo JP, Piche MS, Smet M, Murphy J, Koenig K, Zybura A, Vyhlidal C, Mercier J, Jani N, Kubista M, Birch D, Morse K, Johansson O. Hays A, et al. AAPS J. 2024 Feb 5;26(1):24. doi: 10.1208/s12248-023-00880-9. AAPS J. 2024. PMID: 38316745
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Corsaro B, Yang TY, Murphy R, Sonderegger I, Exley A, Bertholet S, Dakappagari N, Dessy F, Garofolo F, Kierstead L, Koch H, Sarikonda G, Savoie N, Siggers R, Solstad T, Lu Y, Milton M, Marshall JC, DelCarpini J, Gorovits B, Gupta S, Jesaitis L, Kamerud J, Kromminga A, Ma A, McNally J, Yan H, Wu B, Verthelyi D, Kirshner S, Pedras-Vasconcelos J, Rajadhyaksha M, Staack RF, Cherry E, Cludts I, Dahlbäck M, Gunn GR, Ishii-Watabe A, Jawa V, Kubiak R, Partridge M, Petrillo M, Pine SO, Poetzl J, Song S, Stebbins C, Wu Y, Zhang L, Kar S, Liang M, Abhari MR, Schweighardt B, Stubenrauch K, Xu Y. Corsaro B, et al. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276
COVID-19's impact on bioanalytical labs.
Lavelle A, Micheli J. Lavelle A, et al. Bioanalysis. 2021 Aug;13(15):1169-1171. doi: 10.4155/bio-2021-0103. Epub 2021 Aug 10. Bioanalysis. 2021. PMID: 34374298 Free PMC article.
517 results