کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2482599 1556290 2006 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Review of global regulations concerning biowaivers for immediate release solid oral dosage forms
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
پیش نمایش صفحه اول مقاله
Review of global regulations concerning biowaivers for immediate release solid oral dosage forms
چکیده انگلیسی

The regulations with respect to biowaivers for immediate release (IR) solid oral dosage forms in the USA, the EU, Japan and from the World Health Organization (WHO) are summarized and compared. Two case studies are presented, one from our own files and one from the open literature, showing the similarities and the differences among the qualification requirements of the four systems. The regulatory experience gained up to now is reviewed and expected future trends are discussed.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutical Sciences - Volume 29, Issues 3–4, November 2006, Pages 315–324
نویسندگان
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