کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
3461488 | 1231382 | 2007 | 18 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Drug Hepatotoxicity from a Regulatory Perspective
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موضوعات مرتبط
علوم پزشکی و سلامت
پزشکی و دندانپزشکی
پزشکی و دندانپزشکی (عمومی)
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چکیده انگلیسی
This article summarizes problems of drug-induced liver injury (DILI), as seen from the perspective of the Food and Drug Administration (FDA). After brief consideration of the scope of FDA activities and processes of new drug development and review for possible approval of products for clinical use and marketing, some of the perceived current problems in detection, confirmation, close observation, differential diagnosis, and follow-up of cases of possible DILI in controlled clinical trials are described. Readers are invited to consider possible solutions to the many problems of DILI, propose ways to support research in the field, and keep abreast of progress by visiting the web site at www.fda.gov/cder/livertox.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Clinics in Liver Disease - Volume 11, Issue 3, August 2007, Pages 507–524
Journal: Clinics in Liver Disease - Volume 11, Issue 3, August 2007, Pages 507–524
نویسندگان
John R. Senior,