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12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.

التفاصيل البيبلوغرافية
العنوان: 12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
المؤلفون: Briscoe C; PRA Health Sciences, Lenexa, KS, USA., Hughes N; BioPharma Services, 4000 Weston Road, North York, Toronto, M9L 3A2 Ontario, Canada., Hayes R; MPI Research, Mattawan, MI 49071, USA., Islam R; Celerion, Lincoln, Nebraska, NE 68502, USA., Bennett P; PPD Laboratories, Richmond, VA 23230, USA., Stouffer B; PPD Laboratories, Richmond, VA 23230, USA., Cape S; Covance, Madison, WI 53704, USA., Rhyne P; Immunologix Laboratories, Tampa, FL 33634, USA., Beaver C; Syneos Health, Princeton, NJ 08540, USA., Charles JS; MPI Research, Mattawan, MI 49071, USA., Kakkanaiah V; PPD Laboratories, Richmond, VA 23230, USA., Xu A; Keystone Bioanalytical, North wales, PA 19454, USA., Caturla MC; Anapharm Bioanalytics, Barcelona 08038, Spain., Spriggs F; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS 66216, USA., Tayyem R; ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan., Barry C; Alliance Pharma, Malvern, PA 19355, USA., Keyhani A; Altasciences, Laval, Quebec H7V 4B3, Canada., Zimmer J; Alturas Analytics, Moscow, ID 83843, USA., Couerbe P; Atlanbio, Route de Saint-André des Eaux, Saint-Nazaire 44600, France., Warren M; Atlanbio, Route de Saint-André des Eaux, Saint-Nazaire 44600, France., Khadang A; Axis Clinicals, Dilworth, MN 56529, USA., Bourdage J; BASi, West Lafayette, IN 47906, USA., Lindley K; BioAgilytix, Durham, NC 27713, USA., Williams D; BioAgilytix, Durham, NC 27713, USA., Sheldon C; Celerion, Lincoln, Nebraska, NE 68502, USA., Satterwhite C; Charles River Laboratories, Reno, NV 89511, USA., Vija J; Charles River Laboratories, Skokie, IL 60077, USA., Yu M; CIRION Biopharma Research, Laval, Quebec H7L 5E1, Canada., Boulay I; CiToxLAB North America, Laval, Quebec H7V 4B3, Canada., Stamatopoulos J; CiToxLAB North America, Laval, Quebec H7V 4B3, Canada., Lin J; CMIC, Hoffman Estates, IL 60192, USA., Estdale S; Covance, Harrogate, HG3 1PY, UK., Thomas E; Covance, Indianapolis, IN 46214, USA., Dinan A; CPR Pharma Services, Adelaide, SA 5031, Australia., MacNeill R; Envigo, Somerset, NJ 08873, USA., Xiao YQ; Envigo, Somerset, NJ 08873, USA., Matassa L; Frontage Lab, Exton, PA 19341, USA., Garofolo W; Grand Challenges Canada, Toronto, Ontario M5G 1M1, Canada., Savoie N; Grand Challenges Canada, Toronto, Ontario M5G 1M1, Canada., Hristopoulos G; Intertek, San Diego, CA 92121, USA., Xu A; Intertek, San Diego, CA 92121, USA., Goodwin L; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS 66216, USA., Awaiye K; Lambda Therapeutic Research, Toronto, Ontario M1L 4S4, Canada., Ritzén H; Mercodia AB, Uppsala 754 50, Sweden., Bouhajib M; Pharma Medica Research Inc., Mississauga, Ontario L5R 0B7, Canada., Marco CD; Pharma Medica Research Inc., Mississauga, Ontario L5R 0B7, Canada., Savu SR; Pharma Serv International, Bucharest 050853, Romania., Nehls C; PPD Laboratories, Richmond, VA 23230, USA., Tabler E; PPD Laboratories, Richmond, VA 23230, USA., Hays A; PRA Health Sciences, Lenexa, KS, USA., Karnik S; Pyxant Labs, Colorado Springs, CO 80907, USA., Brown M; Q2 Solutions, Marietta, GA 30067, USA., Lowes S; Q2 Solutions, Ithaca, NY 14850, USA., DuBey I; Smithers Avanza, Gaithersburg, MD 20878, USA., Kulagina N; Smithers Avanza, Gaithersburg, MD 20878, USA., Lindsay J; SNBL USA, Everett, WA 98203, USA; currently part of Altasciences., Williard C; Syneos Health, Princeton, NJ 08540, USA., Wang H; TETRAQ, Herston, QLD 4029, Australia., Malone M; Worldwide Clinical Trials, Austin, TX 78754, USA., Wells E; Worldwide Clinical Trials, Austin, TX 78754, USA., Fang X; WuXi Apptec, Plainsboro, NJ 08536, USA., Moussallie M; WuXi Apptec, Plainsboro, NJ 08536, USA.
المصدر: Bioanalysis [Bioanalysis] 2019 Jun; Vol. 11 (12), pp. 1129-1138. Date of Electronic Publication: 2019 Jul 19.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Future Science Country of Publication: England NLM ID: 101512484 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1757-6199 (Electronic) Linking ISSN: 17576180 NLM ISO Abbreviation: Bioanalysis Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : Future Science, 2009-
مواضيع طبية MeSH: Certification* , Chemistry Techniques, Analytical* , Flow Cytometry* , Mass Spectrometry* , Social Control, Formal* , Societies, Scientific*, Oligonucleotides/*analysis, Indicators and Reagents/chemistry
مستخلص: The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.
فهرسة مساهمة: Keywords: CRO; GCC; HRMS; certificate of analysis; critical reagents; flow cytometry; method transfer; oligonucleotides; regulatory findings; stability and immunogenicity
المشرفين على المادة: 0 (Indicators and Reagents)
0 (Oligonucleotides)
تواريخ الأحداث: Date Created: 20190720 Date Completed: 20191213 Latest Revision: 20191217
رمز التحديث: 20240829
DOI: 10.4155/bio-2019-0131
PMID: 31319683
قاعدة البيانات: MEDLINE
الوصف
تدمد:1757-6199
DOI:10.4155/bio-2019-0131