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Wyszukujesz frazę ""Product Surveillance, Postmarketing"" wg kryterium: Temat


Tytuł :
IL-17 Inhibitors and Inflammatory Bowel Diseases: A Postmarketing Study in Vigibase.
Autorzy :
Petitpain N; Regional Centre of Pharmacovigilance, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France.
D'Amico F; Department of Biomedical Sciences, Humanitas University, Milan, Italy.; Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.
Yelehe-Okouma M; Regional Centre of Pharmacovigilance, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France.
Jouzeau JY; Department of Clinical Pharmacology and Toxicology, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France.; Ingénierie Moléculaire et Ingénierie Articulaire (IMoPA), UMR-7365 CNRS, Faculté de Médecine, University of Lorraine and University Hospital of Nancy, Vandoeuvre-lès-Nancy, France.
Netter P; Ingénierie Moléculaire et Ingénierie Articulaire (IMoPA), UMR-7365 CNRS, Faculté de Médecine, University of Lorraine and University Hospital of Nancy, Vandoeuvre-lès-Nancy, France.
Peyrin-Biroulet L; Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.
Gillet P; Regional Centre of Pharmacovigilance, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France.; Ingénierie Moléculaire et Ingénierie Articulaire (IMoPA), UMR-7365 CNRS, Faculté de Médecine, University of Lorraine and University Hospital of Nancy, Vandoeuvre-lès-Nancy, France.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Jul; Vol. 110 (1), pp. 159-168. Date of Electronic Publication: 2021 Feb 12.
Typ publikacji :
Journal Article
MeSH Terms :
Product Surveillance, Postmarketing*
Colitis, Ulcerative/*epidemiology
Crohn Disease/*epidemiology
Interleukin-17/*antagonists & inhibitors
Adult ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Colitis, Ulcerative/etiology ; Crohn Disease/etiology ; Databases, Factual ; Female ; Humans ; Male ; Middle Aged ; Pharmacovigilance ; Retrospective Studies
Czasopismo naukowe
Tytuł :
Suitability of databases in the Asia-Pacific for collaborative monitoring of vaccine safety.
Autorzy :
Duszynski KM; Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
Stark JH; Vaccine Medical, Scientific and Clinical Affairs, Pfizer Inc., New York, New York, USA.
Cohet C; Vaccines Clinical Research & Development, GlaxoSmithKline, Wavre, Belgium.
Huang WT; Office of Preventive Medicine, Taiwan Centers for Disease Control, Taipei, Taiwan.
Shin JY; School of Pharmacy, Sungkyunkwan University, Suwon, South Korea.
Lai EC; School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Man KKC; Research Department of Practice and Policy, UCL School of Pharmacy, London, UK.; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, The University of Hong Kong, Hong Kong.
Choi NK; Department of Health Convergence, Ewha Womans University, Seoul, South Korea.
Khromava A; Epidemiology and Benefit Risk, Sanofi Pasteur Ltd., Toronto, Ontario, Canada.
Kimura T; Astellas Pharma Inc., Northbrook, Illinois, USA.
Huang K; Global Medical Epidemiology, Worldwide Medical and Safety, Pfizer Inc., New York, New York, United States of America.
Watcharathanakij S; Faculty of Pharmaceutical Sciences, Ubon Ratchathani University, Ubon Ratchathani, Thailand.
Kochhar S; Global Healthcare Consulting, New Delhi, India.; Department of Global Health, University of Washington, Seattle, Washington, USA.
Chen RT; Brighton Collaboration, The Task Force for Global Health, Decatur, Georgia, USA.
Pratt NL; Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
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Źródło :
Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2021 Jul; Vol. 30 (7), pp. 843-857. Date of Electronic Publication: 2021 Mar 23.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Health Information Interoperability*
COVID-19/*prevention & control
COVID-19 Vaccines/*adverse effects
Pharmacoepidemiology/*methods
Product Surveillance, Postmarketing/*methods
Asia/epidemiology ; COVID-19/epidemiology ; COVID-19/immunology ; COVID-19/virology ; COVID-19 Vaccines/administration & dosage ; Databases, Factual/statistics & numerical data ; Electronic Health Records/statistics & numerical data ; Geography ; Humans ; International Cooperation ; Pacific Islands/epidemiology ; Pharmacoepidemiology/organization & administration ; Pharmacovigilance ; Product Surveillance, Postmarketing/statistics & numerical data ; SARS-CoV-2/immunology
Czasopismo naukowe
Tytuł :
Analysis of completeness for spontaneous reporting of disease-modifying therapies in multiple sclerosis.
Autorzy :
Araujo AGS; Pharmaceutical Sciences Postgraduate Research Program, Health Sciences Sector, Federal University of Paraná, Curitiba, Brazil.
Lucchetta RC; Department of Drugs and Medicines, Faculty of Pharmaceutical Sciences, São Paulo State University (UNESP), São Paulo, Brazil.
Tonin FS; Pharmaceutical Sciences Postgraduate Research Program, Health Sciences Sector, Federal University of Paraná, Curitiba, Brazil.
Pontarolo R; Department of Pharmacy, Federal University of Paraná, Curitiba, Brazil.
Borba HHL; Department of Pharmacy, Federal University of Paraná, Curitiba, Brazil.
Wiens A; Department of Pharmacy, Federal University of Paraná, Curitiba, Brazil.
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Źródło :
Expert opinion on drug safety [Expert Opin Drug Saf] 2021 Jun; Vol. 20 (6), pp. 735-740. Date of Electronic Publication: 2021 Mar 11.
Typ publikacji :
Journal Article
MeSH Terms :
Adverse Drug Reaction Reporting Systems/*statistics & numerical data
Drug-Related Side Effects and Adverse Reactions/*epidemiology
Multiple Sclerosis/*drug therapy
Product Surveillance, Postmarketing/*statistics & numerical data
Adverse Drug Reaction Reporting Systems/standards ; Humans ; Immunologic Factors/administration & dosage ; Immunologic Factors/adverse effects ; Pharmacovigilance ; Product Surveillance, Postmarketing/standards ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Maternal and neonatal data collection systems in low- and middle-income countries for maternal vaccines active safety surveillance systems: A scoping review.
Autorzy :
Berrueta M; Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1014CPV), Buenos Aires, Argentina. .
Ciapponi A; Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1014CPV), Buenos Aires, Argentina.
Bardach A; Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1014CPV), Buenos Aires, Argentina.
Cairoli FR; Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1014CPV), Buenos Aires, Argentina.
Castellano FJ; Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1014CPV), Buenos Aires, Argentina.
Xiong X; Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, 70112, USA.
Stergachis A; University of Washington, Seattle, WA, 98195-7631, USA.
Zaraa S; University of Washington, Seattle, WA, 98195-7631, USA.
Meulen AS; Bill & Melinda Gates Foundation, Seattle, WA, USA.
Buekens P; Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, 70112, USA.
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Corporate Authors :
Scoping Review Collaboration Group
Źródło :
BMC pregnancy and childbirth [BMC Pregnancy Childbirth] 2021 Mar 17; Vol. 21 (1), pp. 217. Date of Electronic Publication: 2021 Mar 17.
Typ publikacji :
Journal Article; Systematic Review
MeSH Terms :
Health Information Systems*/organization & administration
Health Information Systems*/standards
Infant Health*
Maternal Health*
Product Surveillance, Postmarketing*/methods
Product Surveillance, Postmarketing*/statistics & numerical data
Vaccines/*pharmacology
Data Collection/methods ; Developing Countries ; Female ; Humans ; Immunologic Factors/pharmacology ; Infant, Newborn ; Pharmacovigilance ; Pregnancy ; Vaccination/methods ; Vaccination/standards
Czasopismo naukowe
Tytuł :
Clinical response among golimumab-treated Japanese patients with rheumatoid arthritis by number of previous biologic therapies: Real-world evidence from post-hoc analysis of post-marketing surveillance data.
Autorzy :
Shimizu H; Immunology Department, Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
Kobayashi H; External Collaboration and Portfolio Management Department, Clinical Science Division, R&D Janssen Pharmaceutical K.K., Tokyo, Japan.
Kanbori M; Japan Safety & Surveillance Division, Research & Development Division (R&D), Janssen Pharmaceutical K.K., Tokyo, Japan.
Ishii Y; Immunology Department, Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
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Źródło :
Modern rheumatology [Mod Rheumatol] 2021 May; Vol. 31 (3), pp. 566-574. Date of Electronic Publication: 2020 Aug 19.
Typ publikacji :
Journal Article
MeSH Terms :
Product Surveillance, Postmarketing*
Antibodies, Monoclonal/*therapeutic use
Antirheumatic Agents/*therapeutic use
Arthritis, Rheumatoid/*drug therapy
Biological Products/*therapeutic use
Adult ; Antibodies, Monoclonal/administration & dosage ; Antirheumatic Agents/administration & dosage ; Biological Products/administration & dosage ; Drug Administration Schedule ; Female ; Humans ; Japan ; Male ; Middle Aged ; Treatment Outcome
Czasopismo naukowe
Tytuł :
Expedited Development Programs at the Food and Drug Administration: Insights and Opportunities.
Autorzy :
Collins G; Friends of Cancer Research, Washington, DC, USA.
Stewart M; Friends of Cancer Research, Washington, DC, USA. .; 1800 M Street NW, Suite 1050 South, Washington, DC, 20036, USA. .
Sigal E; Friends of Cancer Research, Washington, DC, USA.
Allen J; Friends of Cancer Research, Washington, DC, USA.
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Źródło :
Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2021 May; Vol. 55 (3), pp. 619-621. Date of Electronic Publication: 2021 Feb 02.
Typ publikacji :
Letter
MeSH Terms :
Drug Approval*
Product Surveillance, Postmarketing*
Problem Solving ; United States ; United States Food and Drug Administration
Opinia redakcyjna
Tytuł :
Post-marketing surveillance of high-dose methotrexate (>8 mg/week) in Japanese patients with rheumatoid arthritis: A post hoc sub-analysis of patients according to duration of prior methotrexate use.
Autorzy :
Suzuki Y; Division of Rheumatology, Department of Internal Medicine, Tokai University School of Medicine, Tokyo, Japan.
Hirose T; Atopy (Allergy) Research Center, Juntendo University School of Medicine, Tokyo, Japan.; Immunology and Inflammation Medical Affairs, Pfizer Innovative Health, Pfizer Japan Inc, Tokyo, Japan.
Sugiyama N; Clinical Statistics, Biometrics and Data Management, Pfizer R&D Japan, Tokyo, Japan.
Nomura K; Post-Marketing Study Strategy and Management, Development Japan, Pfizer R&D Japan, Tokyo, Japan.
Campos-Alberto E; Immunology and Inflammation Medical Affairs, Pfizer Innovative Health, Pfizer Japan Inc, Tokyo, Japan.
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Źródło :
Modern rheumatology [Mod Rheumatol] 2021 May; Vol. 31 (3), pp. 575-586. Date of Electronic Publication: 2021 Jan 21.
Typ publikacji :
Journal Article
MeSH Terms :
Product Surveillance, Postmarketing*
Antirheumatic Agents/*therapeutic use
Arthritis, Rheumatoid/*drug therapy
Methotrexate/*therapeutic use
Adult ; Antirheumatic Agents/administration & dosage ; Female ; Humans ; Japan ; Male ; Methotrexate/administration & dosage ; Middle Aged ; Treatment Outcome
Czasopismo naukowe
Tytuł :
Long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis: 3-year post-marketing surveillance study.
Autorzy :
Tanaka S; Department of Orthopaedic Surgery, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Mizutani H; Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan. .
Tsuruya E; Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
Fukuda R; Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
Kuge K; Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
Okubo N; Biostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
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Źródło :
Journal of bone and mineral metabolism [J Bone Miner Metab] 2021 May; Vol. 39 (3), pp. 463-473. Date of Electronic Publication: 2021 Jan 02.
Typ publikacji :
Journal Article; Observational Study
MeSH Terms :
Asian Continental Ancestry Group*
Product Surveillance, Postmarketing*
Denosumab/*adverse effects
Denosumab/*therapeutic use
Osteoporosis/*drug therapy
Aged ; Biomarkers/metabolism ; Bone Density/drug effects ; Bone Density Conservation Agents/pharmacology ; Bone Density Conservation Agents/therapeutic use ; Bone Remodeling/drug effects ; Female ; Humans ; Hypocalcemia/epidemiology ; Incidence ; Japan ; Male ; Multivariate Analysis ; Osteoporosis/physiopathology ; Osteoporotic Fractures/drug therapy ; Osteoporotic Fractures/physiopathology ; Prospective Studies ; Time Factors ; Treatment Outcome
Czasopismo naukowe
Tytuł :
Effectiveness of golimumab in rheumatoid arthritis patients with inadequate response to first-line biologic therapy: Results from a Japanese post-marketing surveillance study.
Autorzy :
Shimizu H; Immunology Department, Medical Affairs Division, Janssen Pharmaceutical K.K, Tokyo, Japan.
Kobayashi H; External Collaboration and Portfolio Management Department, Clinical Science Division, R&D, Janssen Pharmaceutical K.K, Tokyo, Japan.
Kanbori M; Japan Safety & Surveillance Division, R&D, Janssen Pharmaceutical K.K, Tokyo, Japan.
Ishii Y; Immunology Department, Medical Affairs Division, Janssen Pharmaceutical K.K, Tokyo, Japan.
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Źródło :
Modern rheumatology [Mod Rheumatol] 2021 May; Vol. 31 (3), pp. 556-565. Date of Electronic Publication: 2020 Aug 11.
Typ publikacji :
Journal Article
MeSH Terms :
Product Surveillance, Postmarketing*
Antibodies, Monoclonal/*therapeutic use
Antirheumatic Agents/*therapeutic use
Arthritis, Rheumatoid/*drug therapy
Adult ; Antibodies, Monoclonal/adverse effects ; Antirheumatic Agents/adverse effects ; Female ; Humans ; Japan ; Male ; Middle Aged ; Treatment Outcome
Czasopismo naukowe
Tytuł :
Progress in Immunization Safety Monitoring - Worldwide, 2010-2019.
Autorzy :
Salman O
Topf K
Chandler R
Conklin L
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Źródło :
MMWR. Morbidity and mortality weekly report [MMWR Morb Mortal Wkly Rep] 2021 Apr 16; Vol. 70 (15), pp. 547-551. Date of Electronic Publication: 2021 Apr 16.
Typ publikacji :
Journal Article
MeSH Terms :
Global Health*
Product Surveillance, Postmarketing*
Adverse Drug Reaction Reporting Systems/*statistics & numerical data
Drug-Related Side Effects and Adverse Reactions/*epidemiology
Vaccines/*adverse effects
Humans
Czasopismo naukowe
Tytuł :
Postmarketing observational study of pazopanib in patients with metastatic soft tissue sarcoma in Japan.
Autorzy :
Teshima Y; Novartis Pharma K.K., Tokyo, Japan.
Nomura S; Novartis Pharma K.K., Tokyo, Japan.
Fukasawa N; Novartis Pharma K.K., Tokyo, Japan.
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Źródło :
Japanese journal of clinical oncology [Jpn J Clin Oncol] 2021 Apr 01; Vol. 51 (4), pp. 612-621.
Typ publikacji :
Journal Article; Multicenter Study; Observational Study
MeSH Terms :
Product Surveillance, Postmarketing*
Pyrimidines/*therapeutic use
Sarcoma/*drug therapy
Soft Tissue Neoplasms/*drug therapy
Sulfonamides/*therapeutic use
Adolescent ; Adult ; Aged ; Female ; Humans ; Incidence ; Japan/epidemiology ; Male ; Middle Aged ; Progression-Free Survival ; Pyrimidines/administration & dosage ; Pyrimidines/adverse effects ; Pyrimidines/pharmacology ; Sarcoma/epidemiology ; Sarcoma/pathology ; Soft Tissue Neoplasms/epidemiology ; Soft Tissue Neoplasms/pathology ; Sulfonamides/administration & dosage ; Sulfonamides/adverse effects ; Sulfonamides/pharmacology ; Treatment Outcome ; Young Adult
Czasopismo naukowe
Tytuł :
Estimating Baseline Incidence of Conditions Potentially Associated with Vaccine Adverse Events: a Call for Surveillance System Using the Korean National Health Insurance Claims Data.
Autorzy :
Huh K; Division of Infectious Diseases, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Kim YE; Department of Big Data Strategy, National Health Insurance Service, Wonju, Korea.
Radnaabaatar M; Artificial Intelligence and Big-Data Convergence Center, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
Lee DH; Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
Kim DW; Department of Big Data Strategy, National Health Insurance Service, Wonju, Korea.
Shin SA; Department of Big Data Strategy, National Health Insurance Service, Wonju, Korea. .
Jung J; Artificial Intelligence and Big-Data Convergence Center, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.; Department of Preventive Medicine, Gachon University College of Medicine, Incheon, Korea. .
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Źródło :
Journal of Korean medical science [J Korean Med Sci] 2021 Mar 08; Vol. 36 (9), pp. e67. Date of Electronic Publication: 2021 Mar 08.
Typ publikacji :
Journal Article
MeSH Terms :
Product Surveillance, Postmarketing/*methods
Vaccination/*adverse effects
Anaphylaxis/diagnosis ; Anaphylaxis/epidemiology ; COVID-19/pathology ; COVID-19/virology ; Databases, Factual ; Humans ; Incidence ; Models, Theoretical ; National Health Programs ; Product Surveillance, Postmarketing/statistics & numerical data ; Republic of Korea/epidemiology ; SARS-CoV-2/isolation & purification ; Syncope, Vasovagal/diagnosis ; Syncope, Vasovagal/epidemiology
Czasopismo naukowe
Tytuł :
Safety and effectiveness of adalimumab in Japanese patients with juvenile idiopathic arthritis: Results from a real-world postmarketing study.
Autorzy :
Takei S; Department of Pediatrics, Kagoshima University, Kagoshima, Japan.
Iwata N; Aichi Children's Health and Medical Center, Obu, Aichi, Japan.
Kobayashi I; Hokkaido University, Sapporo, Hokkaido, Japan.
Igarashi T; Department of Pediatrics, Nippon Medical School, Tokyo, Japan.
Yoshinaga Y; AbbVie GK, Tokyo, Japan.
Matsubara N; AbbVie GK, Tokyo, Japan.
Sunaga N; AbbVie GK, Tokyo, Japan.
Ito A; AbbVie GK, Tokyo, Japan.
Yokota S; Fuji Toranomon Orthopedic Hospital, Gotemba, Shizuoka, Japan.
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Źródło :
Modern rheumatology [Mod Rheumatol] 2021 Mar; Vol. 31 (2), pp. 421-430. Date of Electronic Publication: 2020 May 18.
Typ publikacji :
Journal Article
MeSH Terms :
Product Surveillance, Postmarketing*
Adalimumab/*therapeutic use
Antirheumatic Agents/*therapeutic use
Arthritis, Juvenile/*drug therapy
Drug-Related Side Effects and Adverse Reactions/*epidemiology
Adalimumab/adverse effects ; Adolescent ; Adult ; Aged ; Antirheumatic Agents/adverse effects ; Arthritis, Juvenile/blood ; Blood Sedimentation ; Female ; Humans ; Japan ; Male ; Middle Aged ; Treatment Outcome
Czasopismo naukowe
Tytuł :
Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments.
Autorzy :
Guinn D; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Madabushi R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Wang YM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Zineh I; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Maxfield K; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Mar; Vol. 109 (3), pp. 697-704. Date of Electronic Publication: 2020 Sep 28.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
MeSH Terms :
Drug Approval*
Immunologic Tests*
Product Surveillance, Postmarketing*
Antibodies/*immunology
Drug-Related Side Effects and Adverse Reactions/*immunology
Antibody Specificity ; Consumer Product Safety ; Cross Reactions ; Drug Labeling ; Epitopes ; Humans ; Risk Assessment ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products.
Autorzy :
Dhruva SS; Department of Medicine, San Francisco Veterans Affairs Health Care System, and University of California, San Francisco, School of Medicine. Electronic address: .
Shah ND; Division of Health Care Policy and Research and Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.
Ross JS; Section of General Internal Medicine and National Clinician Scholars Program, Yale School of Medicine, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT.
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Źródło :
Mayo Clinic proceedings [Mayo Clin Proc] 2020 Dec; Vol. 95 (12), pp. 2609-2611. Date of Electronic Publication: 2020 Oct 21.
Typ publikacji :
Journal Article
MeSH Terms :
Device Approval*/legislation & jurisprudence
Device Approval*/standards
Mandatory Reporting*
Product Surveillance, Postmarketing*/methods
Product Surveillance, Postmarketing*/standards
Access to Information ; Clinical Decision-Making ; Humans ; Public Reporting of Healthcare Data ; Registries/standards ; Risk Assessment ; United States
Czasopismo naukowe
Tytuł :
[Review of near real-time vaccine safety surveillance].
Autorzy :
Sun YX; Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China.
Liu ZK; Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China.
Nie XL; Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China; Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China.
Zhan SY; Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China.
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Źródło :
Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi [Zhonghua Liu Xing Bing Xue Za Zhi] 2021 Feb 10; Vol. 42 (2), pp. 351-356.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Product Surveillance, Postmarketing*
Vaccines*/adverse effects
China ; Humans
Czasopismo naukowe
Tytuł :
Safety and effectiveness of oral blonanserin for schizophrenia: A review of Japanese post-marketing surveillances.
Autorzy :
Inoue Y; Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan. Electronic address: .
Tsuchimori K; Corporate Governance Material Review Group, Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan. Electronic address: .
Nakamura H; Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan. Electronic address: .
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Źródło :
Journal of pharmacological sciences [J Pharmacol Sci] 2021 Jan; Vol. 145 (1), pp. 42-51. Date of Electronic Publication: 2020 Oct 08.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Product Surveillance, Postmarketing*
Antipsychotic Agents/*administration & dosage
Piperazines/*administration & dosage
Piperidines/*administration & dosage
Schizophrenia/*drug therapy
Administration, Oral ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Akathisia, Drug-Induced/etiology ; Antipsychotic Agents/adverse effects ; Antipsychotic Agents/pharmacology ; Basal Ganglia Diseases/etiology ; Child ; Female ; Humans ; Japan ; Male ; Middle Aged ; Piperazines/adverse effects ; Piperazines/pharmacology ; Piperidines/adverse effects ; Piperidines/pharmacology ; Safety ; Treatment Outcome ; Young Adult
Czasopismo naukowe
Tytuł :
[Enlightenment on Carrying out Reporting Responsibility of Manufactures in China from Reviewing Medical Device Reporting Practice in US].
Autorzy :
Zhao Y; Center for Drug Reevaluation, National Medical Products Administration, Beijing, 100022.
Dong F; Center for Drug Reevaluation, National Medical Products Administration, Beijing, 100022.
Zhao Y; Center for Drug Reevaluation, National Medical Products Administration, Beijing, 100022.
Zheng L; Center for Drug Reevaluation, National Medical Products Administration, Beijing, 100022.
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Źródło :
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation [Zhongguo Yi Liao Qi Xie Za Zhi] 2020 Dec 08; Vol. 44 (6), pp. 545-548.
Typ publikacji :
Journal Article
MeSH Terms :
Product Surveillance, Postmarketing*
Equipment and Supplies/*standards
China
Czasopismo naukowe
Tytuł :
The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices.
Autorzy :
Tsougranis G; Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; VA Outcomes Group, White River Junction VA Medical Center, White River Junction, Vt; Geisel School of Medicine at Dartmouth, Hanover, NH.
Eldrup-Jorgensen J; Division of Vascular Surgery, Maine Medical Center, Portland, Me.
Bertges D; Section of Vascular Surgery, University of Vermont Medical Center, Burlington, Vt.
Schermerhorn M; Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass.
Morales P; Center for Devices and Radiological Health, United States Food and Drug Administration, Rockville, Md.
Williams S; Cook Medical, Inc, Bloomington, Ind.
Bloss R; W. L. Gore & Associates, Inc., Flagstaff, Ariz.
Simons J; Division of Vascular Surgery, UMass Memorial Medical Center, Boston, Mass.
Deery SE; Department of Surgery, Massachusetts General Hospital, Boston, Mass.
Scali S; Department of Surgery, University of Florida School of Medicine, Gainesville, Fla.
Roche-Nagle G; Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Mureebe L; Division of Vascular Surgery, Duke University School of Medicine, Durham, NC.
Mell M; Division of Surgery at University of California, Davis, NC.
Malas M; Vascular and Endovascular Surgery at University of California, San Diego, Calif.
Pullin B; Center for Devices and Radiological Health, United States Food and Drug Administration, Rockville, Md.
Stone DH; Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; VA Outcomes Group, White River Junction VA Medical Center, White River Junction, Vt.
Malone M; Center for Devices and Radiological Health, United States Food and Drug Administration, Rockville, Md.
Beck AW; Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, Ala.
Wang G; Vascular and Endovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pa.
Marinac-Dabic D; Center for Devices and Radiological Health, United States Food and Drug Administration, Rockville, Md.
Sedrakyan A; Weill Cornell Medical Center, New York, NY.
Goodney PP; Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; VA Outcomes Group, White River Junction VA Medical Center, White River Junction, Vt. Electronic address: .
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Źródło :
Journal of vascular surgery [J Vasc Surg] 2020 Dec; Vol. 72 (6), pp. 2153-2160. Date of Electronic Publication: 2020 May 20.
Typ publikacji :
Journal Article; Research Support, U.S. Gov't, P.H.S.
MeSH Terms :
Equipment and Supplies*
Product Surveillance, Postmarketing*
Public-Private Sector Partnerships*
United States Food and Drug Administration*
Endovascular Procedures/*instrumentation
Vascular Surgical Procedures/*instrumentation
Endovascular Procedures/adverse effects ; Equipment Design ; Evidence-Based Medicine ; Humans ; International Cooperation ; Patient Safety ; Population Surveillance ; Registries ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome ; United States ; Vascular Surgical Procedures/adverse effects
Czasopismo naukowe
Tytuł :
Assessing the Safety of COVID-19 Vaccines: A Primer.
Autorzy :
Petousis-Harris H; Department of General Practice and Primary Health Care, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. .
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Źródło :
Drug safety [Drug Saf] 2020 Dec; Vol. 43 (12), pp. 1205-1210. Date of Electronic Publication: 2020 Sep 30.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Development*
Product Surveillance, Postmarketing*
COVID-19/*prevention & control
COVID-19 Vaccines/*adverse effects
COVID-19 Vaccines/therapeutic use ; Clinical Trials, Phase IV as Topic ; Drug Approval ; Humans ; Pharmacoepidemiology ; Pharmacovigilance ; SARS-CoV-2
Czasopismo naukowe

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