کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
9901440 | 1545421 | 2005 | 8 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Differences in product information of biopharmaceuticals in the EU and the USA: implications for product development
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
بیوتکنولوژی یا زیستفناوری
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چکیده انگلیسی
The Summary of Product Characteristics (SPC) approved by the European Medicines Agency (EMEA) and the Package Insert (PI) approved by the Food and Drug Administration (FDA) were examined for 32 biopharmaceutical products. The aim was to identify differences in the product information since such information may have an impact on the planning of global clinical development programmes. The EU SPC contained more detailed instructions to the prescriber, including the positioning of the product with regard to the stage of the disease and to other therapies. The approach to safety information, notably to contraindications and warnings was more conservative in the EU SPC. The conservative approach in the EU may reflect the central position of the SPC in risk management of new pharmaceuticals. A typical feature of the US PI was the detailed description of the efficacy and safety result of the pivotal clinical trials.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutics and Biopharmaceutics - Volume 60, Issue 3, August 2005, Pages 319-326
Journal: European Journal of Pharmaceutics and Biopharmaceutics - Volume 60, Issue 3, August 2005, Pages 319-326
نویسندگان
Outi Nieminen, Pekka Kurki, Katrina Nordström,