Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.-临床诊疗知识库

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A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72

作者：M, Kalaivani；Abhishank, Singh；V, Kalaiselvan

来源：mAbs 2015 年 7卷 1期

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Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.

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作者：

M, Kalaivani；Abhishank, Singh；V, Kalaiselvan

来源：

mAbs 2015 年 7卷 1期

标签：

ADR, adverse drug reactions ADR/E, adverse drug reactions/event AMCs, ADR monitoring centers CDSCO, Central Drugs Standard Control Organization CLL, chronic lymphocytic leukemia DCGI, Drug Controller General of India EMA, European Medicines Agency EU, European Union GEAC, Genetic Engineering Appraisal Committee HBV, hepatitis B virus ICSRs, Individual Case Safety Reports IPC, Indian Pharmacopoeia Commission MHRA, Medicines and Healthcare Products Regulatory Agency MedDRA, Medical Dictionary for Regulatory Activities MoEF, Ministry of Environment and Forests MoHFW, Ministry of Health and Family Welfare NCC-PvPI NCC-PvPI, National Coordination Centre-Pharmacovigilance Program of India NHL, non Hodgkin lymphoma NRA, National Regulatory Authority PML, progressive multifocal leukoencephalopathy PSUR, Periodic Safety Updates Report RCGM, Review Committee on Genetic Manipulation SOC, System Organ Class US, Unites States of America USFDA, United States Food and Drug Administration Vigiflow WHO, World Health Organization mAb, monoclonal antibody mAbs, monoclonal antibodies monoclonal antibody rDNA, recombinant DNA spontaneous reporting targeted pharmacovigilance

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