کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5856753 | 1131982 | 2014 | 8 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework
ترجمه فارسی عنوان
مفاهیم کنونی در مورد ارزیابی ایمنی یکپارچه از مواد فعال گیاه شناسی، مواد معدنی یا شیمیایی در داروهای هومیوپاتی در چارچوب قانونی اروپا
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کلمات کلیدی
RfDThreshold of toxicological concern (TTC)Ph. Eur.FSDTDIPTCHMAGHPTTCPDEADI - NAMEThreshold of toxicological concern - آستانه نگرانی سمیSafety assessment - ارزیابی ایمنیAcceptable daily intake - دریافت روزانه قابل قبولReference dose - دوز مرجعEuropean Pharmacopoeia - فارماکوپه اروپاییPermitted daily exposure - قرار گرفتن در معرض روزانه مجاز استTolerable daily intake - مصرف روزانه قابل تحملNaphthoquinones - نفتووکینون ها
موضوعات مرتبط
علوم زیستی و بیوفناوری
علوم محیط زیست
بهداشت، سم شناسی و جهش زایی
چکیده انگلیسی
For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 68, Issue 2, March 2014, Pages 193-200
Journal: Regulatory Toxicology and Pharmacology - Volume 68, Issue 2, March 2014, Pages 193-200
نویسندگان
Marie-Luise Buchholzer, Christine Werner, Werner Knoess,