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Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions.

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第一作者： Greg,Ball

第一单位： Clinical Safety Statistics, Merck Research Laboratories, RY 34-A318, 126 E Lincoln Ave, Rahway, NJ, 07065-4607, USA. Greg.Ball@Merck.com.

作者： Greg,Ball ^[1] ; Raffael,Kurek ^[2] ; Barbara A,Hendrickson ^[3] ; James,Buchanan ^[4] ; William W,Wang ^[5] ; Susan P,Duke ^[6] ; Amit,Bhattacharyya ^[7] ; Mengchun,Li ^[8] ; Dennis,O'Brien ^[9] ; Judith,Weigel ^[10] ; Wenquan,Wang ^[11] ; Qi,Jiang ^[12] ; Faiz,Ahmad ^[13] ; Jonathan H,Seltzer ^[14] ; Esteban,Herrero-Martinez ^[15] ; Lothar,Tremmel ^[16]

作者单位： Clinical Safety Statistics, Merck Research Laboratories, RY 34-A318, 126 E Lincoln Ave, Rahway, NJ, 07065-4607, USA. Greg.Ball@Merck.com. ^[1] Global Patient Safety, Eli Lilly and Company, Windlesham, UK. ^[2] Pharmacovigilance and Patient Safety, AbbVie, North Chicago, IL, USA. ^[3] Covilance LLC, Belmont, CA, USA. ^[4] Clinical Safety Statistics, Merck Research Laboratories, North Wales, PA, USA. ^[5] Office of Biostatistics, Center for Drug Evaluation, Food and Drug Administration, Silver Spring, MD, USA. ^[6] Biometrics, ACI Clinical, Bala Cynwyd, PA, USA. ^[7] Global Alliance for TB Drug Development, New York City, NY, USA. ^[8] Risk Management, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA. ^[9] Pharmacovigilance, vfa Research-Based Pharmaceutical Companies, Berlin, Germany. ^[10] Biostatistics, Sanofi Pasteur, Swiftwater, PA, USA. ^[11] Biometrics, Seattle Genetics, Bothell, WA, USA. ^[12] US Biostatistics, Galderma R&D, Fort Worth, TX, USA. ^[13] ACI Clinical, Bala Cynwyd, PA, USA. ^[14] Regulatory Policy and Intelligence, AbbVie, Maidenhead, UK. ^[15] Biostatistics and Medical Writing, CSL Behring, King of Prussia, PA, USA. ^[16]

关键词 RSI SUSAR aggregate safety assessment interdisciplinary safety evaluation medical judgment

医学主题词人类(Humans);产品监测, 售后(Product Surveillance, Postmarketing);危险性评估(Risk Assessment)

DOI 10.1007/s43441-019-00076-4

PMID 32072595

发布时间 2021-06-02

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准确一般字义偏差语意偏离译文作用小提交