کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2072365 1078957 2007 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Toxicological overview of impurities in pharmaceutical products
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی بیوتکنولوژی یا زیست‌فناوری
پیش نمایش صفحه اول مقاله
Toxicological overview of impurities in pharmaceutical products
چکیده انگلیسی

While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control impurities in drug substances and drug products. While impurities should always be reduced to the lowest levels that are reasonably practical, it is acknowledged that impurities cannot be reduced to zero and specifications for impurities need to be established. This chapter discusses practical and theoretical methods for qualification of different classes of impurities.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Advanced Drug Delivery Reviews - Volume 59, Issue 1, 10 January 2007, Pages 38–42
نویسندگان
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