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- W2371372126 abstract "OBJECTIVE: To evaluate bioavailability and safety of clinical efficacy of biological generic drug according to the requirement of drug safety and pharmacovigilance, and to formulate the pharmacovigilance plan for it. METHODS: Problems of biological generic drug in China were analyzed in terms of preliminary study, clinical trial and production. RESULTSCONCLUSION: Biological generic drugs are similar but not same, and the production process is complex and easily results in variable. It is necessary to evaluate clinical safety of drugs. Medical institutions should be intensely focused on self-checking, sampling inspection, supervision and management, find out problems to improve safety of biological generic drugs in China." @default.
- W2371372126 created "2016-06-24" @default.
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- W2371372126 date "2012-01-01" @default.
- W2371372126 modified "2023-09-23" @default.
- W2371372126 title "Formulation of Pharmacovigilance Plan of Biological Generic Drug" @default.
- W2371372126 hasPublicationYear "2012" @default.
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