Recommendations on qPCR/ddPCR assay validation by GCC.

Autor: Wissel M; Eurofins Viracor BioPharma, Lenexa,Kansas, USA., Poirier M; Altasciences, Everett, Washington, USA., Satterwhite C; Charles River Laboratories, Reno, Nevada, USA., Lin J; Frontage Laboratories, Exton, Pennsylvania, USA., Islam R; Smithers, Gaithersburg, Maryland, USA., Zimmer J; Alturas Analytics, Moscow, Idaho, USA., Khadang A; Axis Clinical, Dilworth, Minnesota, USA., Zemo J; BioAgilytix, Durham, North Carolina, USA., Lester T; BioAgilytix, Durham, North Carolina, USA., Fjording M; BioAgilytix, Durham, North Carolina, USA., Hays A; BioAgilytix, Durham, North Carolina, USA., Hughes N; Biopharmaservices, Toronto, Ontario, Canada., Garofolo F; BRI - a Frontage Company, Vancouver, British Columbia, Canada., Guilbaud R; CellCarta, Montreal, Quebec, Canada., Groeber E; Charles River Laboratories, Ashland, Ohio, USA., Renfrew H; Charles River Laboratories, Shrewsbury, Massachusetts, USA., Colletti K; Charles River Laboratories, Reno, Nevada, USA., Yu M; CIRION, Montreal, Quebec, Canada., Lin J; CMIC, Hoffman Estates, Illinois, USA., Fang X; CR Medicon, Piscataway, New Jersey, USA., Shah S; Frontage Laboratories, Exton, Pennsylvania, USA., Garofolo W; GCC, Toronto, Ontario, Canada., Kar S; GCC, Toronto, Ontario, Canada., Hayes R; ICON Laboratory Services, Whitesboro, New York, USA., Pirro J; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA., Kane C; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA., Luna M; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA., Xu A; Keystone Bioanalytical, Lansdale, Pennsylvania, USA., Cape S; Labcorp, Madison, Wisconsin, USA., O'Dell M; Labcorp, Indianapolis, Indiana, USA., Wheller R; LGC, Ely, UK., Ritzen H; Mercodia, Uppsala, Sweden., Vance J; Nexelis - a Q2 Solutions Company, Seattle, Washington, USA., Farley E; Pharmaron, Germantown, Maryland, USA., Matys K; PPD Laboratories, Richmond, Virginia, USA., Tabler E; PPD Laboratories, Richmond, Virginia, USA., Mylott W; PPD Laboratories, Richmond, Virginia, USA., Yuan M; PPD Laboratories, Richmond, Virginia, USA., Karnik S; Pyxant Labs, Colorado Springs, Colorado, USA., Voelker T; Pyxant Labs, Salt Lake City, Utah, USA., DuBey I; Smithers, Gaithersburg, Maryland, USA., Williard C; Syneos Health, Princeton, New Jersey, USA., Shi J; WuXi AppTec, Plainsboro, New Jersey, USA., Yamashita J; WuXi AppTec, Plainsboro, New Jersey, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2022 Jun; Vol. 14 (12), pp. 853-863. Date of Electronic Publication: 2022 Jun 15.

Biological Matrix Supply Chain Shortages: More Matrices Are Now Rare-the Case for Surrogate Matrices.

Autor: Dubiel EA; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Myler H; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA. Heather.Myler@ppd.com., Arnold ME; Labcorp Drug Development, 8211 SciCor Drive, Indianapolis, Indiana, 46214, USA., Bennett P; Alliance Pharma Inc., 17 Lee Blvd., Malvern, Pennsylvania, 19355, USA., Gatz J; BioIVT LLC, PO Box 770, Hicksville, New York, 11802, USA., Groeber E; Charles River Laboratories, 1407 George Rd, Ashland, Ohio, 44805, USA., Gupta S; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Kane C; KCAS Bioanalytical and Biomarker Services, 12400 Shawnee Mission Parkway, Shawnee, Kansas, 66216, USA., Li F; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Mylott W; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Noah C; BioIVT LLC, PO Box 770, Hicksville, New York, 11802, USA., O'Dell M; Labcorp Drug Development, 8211 SciCor Drive, Indianapolis, Indiana, 46214, USA., Tewalt E; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Warrino D; KCAS Bioanalytical and Biomarker Services, 12400 Shawnee Mission Parkway, Shawnee, Kansas, 66216, USA., Vick A; Charles River Laboratories, 1407 George Rd, Ashland, Ohio, 44805, USA.

Publikováno v: The AAPS journal [AAPS J] 2022 Mar 14; Vol. 24 (2), pp. 42. Date of Electronic Publication: 2022 Mar 14.

Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.

Autor: Bower J; Precision for Medicine, Frederick, MD, USA., Zimmer J; Alturas Analytics, Moscow, ID, USA., McCown S; PRA Health Sciences, Lenexa, KS, USA., Tabler E; PPD Laboratories, Richmond, VA, USA., Karnik S; Pyxant Labs, Colorado Springs, CO, USA., Kar S; GCC, Toronto, ON, Canada., Sales K; Agilex Biolabs, Adelaide, Australia., Vance J; AIT Bioscience, Indianapolis, IN, USA., Barry C; Alliance Pharma, Malvern, PA, USA., Keyhani A; Altasciences, Everett, WA, USA., Williams D; BioAgilytix, Durham, NC, USA., Lester T; BioAgilytix, Durham, NC, USA., Garofolo F; BRI Biopharmaceutical Research, Vancouver, BC, Canada., Satterwhite C; Charles River Laboratories, Reno, NV, USA., Groeber E; Charles River Laboratories, Ashland, OH, USA., Renfrew H; Charles River Laboratories, Shrewsbury, MA, USA., Lin J; CMIC, Hoffman Estates, IL, USA., Cape S; Covance, Madison, WI, USA., O'Dell M; Covance, Indianapolis, IN, USA., Fang X; CRMedicon, Piscataway, NJ, USA., Brant A; Eurofins Bioanalytical Services, St Charles, MO, USA., Garofolo W; GCC, Toronto, ON, Canada., Savoie N; GCC, Toronto, ON, Canada., Hayes R; ICON Laboratory Services, Whitesboro, NY, USA., Simchik S; ICON Laboratory Services, Whitesboro, NY, USA., Sun R; Inotiv, West Lafayette, IN, USA., Bravo O; Inotiv, West Lafayette, IN, USA., Dufield D; Intertek, San Diego, CA, USA., Luna M; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Xu A; Keystone Bioanalytical, Lansdale, PA, USA., Kane C; Nexelis, Seattle, WA, USA., Farley E; Pharmaron, Germantown, MD, USA., Sanghvi M; Pharmaron, Germantown, MD, USA., Hays A; PRA Health Sciences, Lenexa, KS, USA., Lowes S; Q2 Solutions, Ithaca, NY, USA., Islam R; Smithers, Gaithersburg, MD, USA., Hoffpauir B; Smithers, Gaithersburg, MD, USA., Beaver C; Syneos Health, Quebec City, QC, Canada., Dong K; United-Power Pharma, Beijing, China., Desai-Krieger D; Worldwide Clinical Trials, Austin, TX, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2021 Apr; Vol. 13 (8), pp. 609-619. Date of Electronic Publication: 2021 Apr 13.

The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.

Autor: Cape S; Covance, Madison, WI, USA., Islam R; Celerion, Lincoln, NE, USA., Nehls C; PPD Laboratories, Madison, WI, USA., Allinson J; LGC, Fordham, UK., Safavi A; BioAgilytix, Durham, NC, USA., Bennett P; PPD Laboratories, Madison, WI, USA., Hulse J; Eurofins Pharma Bioanalytics Services, Saint Charles, MO, USA., Beaver C; inVentiv Health, Princeton, NJ, USA., Khan M; Alliance Pharma, Malvern, PA, USA., Karnik S; Pyxant Labs, Colorado Springs, CO, USA., Caturla MC; Anapharm Europe, Barcelona, Spain., Lowes S; Q2 Solutions, Ithaca, NY, USA., Iordachescu A; 3S - Pharmacological Consultation, Bucharest, Romania., Silvestro L; 3S - Pharmacological Consultation, Bucharest, Romania., Tayyem R; ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan., Shoup R; AIT Bioscience, Indianapolis, IN, USA., Mowery S; Previously with AIT Bioscience, Indianapolis, IN, USA., Keyhani A; Algorithme Pharma, Laval, Quebec, Canada., Wakefield A; Previously with Algorithme Pharma, Laval, Quebec, Canada., Li Y; Alliance Pharma, Malvern, PA, USA., Zimmer J; Alturas Analytics, Moscow, ID, USA., Torres J; Anapharm Europe, Barcelona, Spain., Couerbe P; Atlanbio, Saint-Nazaire, France., Khadang A; Axis Clinicals, Dilworth, MN, USA., Bourdage J; BASi, West Lafayette, IN, USA., Hughes N; Bioanalytical Laboratory Services, Toronto, Ontario, Canada (currently BioPharma Services)., Awaiye K, Matthews B, Fatmi S; Biotrial Bioanalytical Services Inc., Laval, Quebec, Canada., Johnson R; Celerion, Lincoln, NE, USA., Satterwhite C; Charles River Laboratories, Reno, NV, USA., Yu M; CIRION Biopharma Research, Laval, Quebec, Canada., Lin J; CMIC, Hoffman Estates, IL, USA., Cojocaru L; Covance, West Trenton, NJ, USA., Fiscella M; Covance, Chantilly, VA, USA., Thomas E; Covance, Indianapolis, IN, USA., Kurylak K; Envigo, Somerset, NJ, USA., Kamerud J; Eurofins Pharma Bioanalytics Services, Saint Charles, MO, USA., Lin ZJ; Frontage Lab, Exton, PA, USA., Garofolo W; GCC, Toronto, Ontario, Canada., Savoie N; GCC, Toronto, Ontario, Canada., Buonarati M; Intertek, San Diego, CA, USA., Boudreau N; inVentiv Health, Quebec City, Quebec, Canada., Williard C; inVentiv Health, Princeton, NJ, USA., Liu Y; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Warrino D; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Kale P; Lambda Therapeutic Research, Ahmedabad, India., Adcock N; LGC, Fordham, UK., Shekar R; Lotus Labs Pvt. Ltd., Bangalore, India., O'Connor E; Loveless Respiratory Research Institute, Albuquerque, NM, USA., Ritzen H; Mercodia AB, Uppsala, Sweden., Sanchez C; MicroConstants, San Diego, CA, USA., Hayes R; MPI Research, Mattawan, MI, USA., Bouhajib M; Pharma Medica Research, Inc., Mississauga, Ontario, Canada., Savu SR; Pharma Serv International, Bucharest, Romania., Stouffer B; PPD Laboratories, Richmond, VA, USA., Tabler E; PPD Laboratories, Richmond, VA, USA., Tu J; PPD Laboratories, Richmond, VA, USA., Briscoe C; PRA Health Sciences, Lenexa, KS, USA., der Strate BV; PRA Health Sciences, Assen, The Netherlands., Rhyne P; Q2 Solutions, Marietta, GA, USA., Conliffe P; Smithers Avanza, Gaithersburg, MD, USA., DuBey I; Smithers Avanza, Gaithersburg, MD, USA., Yamashita J; SNBL USA, Everett, WA, USA., Tang D; UP-Pharmatech, Beijing, China., Groeber E; WIL Research, Ashland, OH, USA (currently Charles River)., Vija J; WIL Research, Skokie, IL, USA (currently Charles River)., Malone M; Worldwide Clinical Trials, Cedar Park, TX, USA., Osman M; WuXi Apptec, Plainsboro, NJ, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2017 Apr; Vol. 9 (7), pp. 505-516. Date of Electronic Publication: 2017 Mar 24.

Boston Society's 11th Annual Applied Pharmaceutical Analysis conference.

Autor: Lee V; Genentech, Inc., South San Francisco, CA, USA., Liu A; Bristol-Myers Squibb, Analytical & Bioanalytical Development, Princeton, NJ, USA., Groeber E; WIL Research, Ashland, OH, USA., Moghaddam M; Celgene Corp., Discovery DMPK, San Diego, CA, USA., Schiller J; Merck & Co., Regulated Bioanalytical - PPDM, West Point, PA, USA., Tweed JA; Pfizer, Inc., Worldwide Pharmacokinetics & Metabolism - NCE, Groton, CT, USA., Walker GS; Pfizer, Inc., Worldwide Pharmacokinetics & Metabolism - NCE, Groton, CT, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2016 Feb; Vol. 8 (4), pp. 259-64. Date of Electronic Publication: 2016 Feb 08.