Artificial intelligence and real-world data for drug and food safety - A regulatory science perspective.

Autor: Thakkar S; Center for Drug Evaluations and Research (CDER), Food and Drug Administration (FDA), USA., Slikker W Jr; National Center for Toxicological Research (NCTR), Food and Drug Administration (FDA), USA., Yiannas F; Food and Drug Administration (FDA), USA., Silva P; Canadian Food Inspection Agency (CFIA), Canada., Blais B; Canadian Food Inspection Agency (CFIA), Canada., Chng KR; National Centre for Food Science, Singapore Food Agency (SFA), Singapore., Liu Z; National Center for Toxicological Research (NCTR), Food and Drug Administration (FDA), USA., Adholeya A; The Energy and Resources Institute (TERI), New Delhi, India., Pappalardo F; University of Catania, Italy., Soares MDLC; Brazilian Health Regulatory Agency (ANVISA), Brazil., Beeler PE; Swissmedic, Bern, Switzerland; University of Zurich, Zurich, Switzerland., Whelan M; Joint Research Center (JRC), Spain., Roberts R; Apconix, UK., Borlak J; Hannover Medical School, Germany., Hugas M; European Food Safety Authority (EFSA), Italy., Torrecilla-Salinas C; Joint Research Center (JRC), Spain., Girard P; Swissmedic, Bern, Switzerland., Diamond MC; Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), USA., Verloo D; European Food Safety Authority (EFSA), Italy., Panda B; Jawaharlal Nehru University (JNU), New Delhi, India., Rose MC; Burroughs Wellcome Fund (BWF), USA., Jornet JB; European Medical Agency (EMA), the Netherlands., Furuhama A; National Institute of Health Sciences (NIHS), Japan., Fang H; National Center for Toxicological Research (NCTR), Food and Drug Administration (FDA), USA., Kwegyir-Afful E; Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA), USA., Heintz K; Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA), USA., Arvidson K; Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA), USA., Burgos JG; European Medical Agency (EMA), the Netherlands., Horst A; Swissmedic, Bern, Switzerland., Tong W; National Center for Toxicological Research (NCTR), Food and Drug Administration (FDA), USA. Electronic address: Weida.tong@fda.hhs.gov.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 May; Vol. 140, pp. 105388. Date of Electronic Publication: 2023 Apr 13.

European Pharmacopoeia foot-and-mouth disease vaccine potency testing in cattle: Between test variability and its consequences

Autor: Goris, N., Merkelbach-Peters, P., Diev, V.I., Verloo, D., Zakharov, V.M., Kraft, H.-P., De Clercq, K.

Publikováno v: In Vaccine 2007 25(17):3373-3379

Recombinant RoTat 1.2 variable surface glycoprotein as antigen for diagnosis of Trypanosoma evansi in dromedary camels

Autor: Lejon, V. ^*, Claes, F., Verloo, D., Maina, M., Urakawa, T., Majiwa, P.A.O., Büscher, P.

Publikováno v: In International Journal for Parasitology 2005 35(4):455-460

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Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks.

Autor: Hoffmann S; Evidence-based Toxicology Collaboration (EBTC) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Aiassa E; European Food Safety Authority (EFSA), Parma, Italy., Angrish M; United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessment, Research Triangle Park, NC, USA., Beausoleil C; ANSES, Risk Assessment Department, Maisons-Alfort, France., Bois FY; Certara UK, Simcyp Division, Sheffield, UK., Ciccolallo L; European Food Safety Authority (EFSA), Parma, Italy., Craig PS; Durham University, Durham, UK., De Vries RBM; Evidence-based Toxicology Collaboration (EBTC) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Dorne JLCM; European Food Safety Authority (EFSA), Parma, Italy., Druwe IL; United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessment, Research Triangle Park, NC, USA., Edwards SW; RTI International, Research Triangle Park, NC, USA., Eskes C; SeCAM, Magliaso, Switzerland.; current affiliation: European Food Safety Authority (EFSA), Parma, Italy., Georgiadis M; European Food Safety Authority (EFSA), Parma, Italy., Hartung T; Evidence-based Toxicology Collaboration (EBTC) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; CAAT-Europe, University of Konstanz, Konstanz, Germany., Kienzler A; European Commission, Joint Research Centre, Ispra, Italy.; current affiliation: European Food Safety Authority (EFSA), Parma, Italy., Kristjansson EA; University of Ottawa, Ottawa, Canada., Lam J; California State University, East Bay, CA, USA., Martino L; European Food Safety Authority (EFSA), Parma, Italy., Meek B; University of Ottawa, Ottawa, Canada., Morgan RL; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada., Munoz-Guajardo I; European Food Safety Authority (EFSA), Parma, Italy., Noyes PD; United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessment, Research Triangle Park, NC, USA., Parmelli E; European Commission, Joint Research Centre, Ispra, Italy., Piersma A; Centre for Health Protection (RIVM), Bilthoven, the Netherlands., Rooney A; Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA., Sena E; University of Edinburgh, Edinburgh, UK., Sullivan K; Physicians Committee for Responsible Medicine, Washington, DC, USA., Tarazona J; European Food Safety Authority (EFSA), Parma, Italy., Terron A; European Food Safety Authority (EFSA), Parma, Italy., Thayer K; United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessment, Research Triangle Park, NC, USA., Turner J; Safer Medicines Trust, Kingsbridge, UK., Verbeek J; University of Eastern Finland, Kuopio, Finland, Verloo D; European Food Safety Authority (EFSA), Parma, Italy., Vinken M; Vrije Universiteit Brussel, Brussels, Belgium., Watford S; Booz Allen Hamilton, Rockville, MD, USA., Whaley P; Evidence-based Toxicology Collaboration (EBTC) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; Lancaster Environment Centre, Lancaster University, Lancaster, UK., Wikoff D; ToxStrategies, Asheville, NC, USA., Willett K; Humane Society International, Washington, DC, USA., Tsaioun K; Evidence-based Toxicology Collaboration (EBTC) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Publikováno v: ALTEX [ALTEX] 2022; Vol. 39 (3), pp. 499–518. Date of Electronic Publication: 2022 Mar 01.