کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
8551883 1562111 2017 8 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Non-clinical efficacy-related studies for human medicines: An overview and retrospective analysis of data for a group of approved medicines
ترجمه فارسی عنوان
مطالعات مرتبط با اثربخشی غیر بالینی برای داروهای انسانی: یک بررسی کلی و تجزیه و تحلیل گذشته نگر از داده ها برای یک گروه از داروهای تایید شده
موضوعات مرتبط
علوم زیستی و بیوفناوری علوم محیط زیست بهداشت، سم شناسی و جهش زایی
چکیده انگلیسی
The lack of efficacy is a major cause of medicine's development failure at the clinical phase, which may lead to question, among other aspects, the translation of the non-clinical data into humans. The objectives of the work here presented were (i) to get an overview (based on public assessment reports) of the nature of the non-clinical efficacy-related studies presented to the regulatory authorities at the marketing authorization application's stage for a group of approved anticancer human medicines (15 in total) and (ii) to conduct a retrospective analysis of such studies in terms of any identified insufficiencies and consistency with the current regulatory non-clinical guidelines. Each medicine has been tested in a number of in vitro assays and animal studies, which, all together, are judged to be capable of providing information on the activity of the active substance and demonstrating an anti-tumour effect, as well as to be generally consistent with the available, although limited detailed, guidance. In spite of this, some aspects were identified which could have a potential impact on the translation on non-clinical data into humans, namely, apparent insufficiencies in terms of animal model/human bridging data/knowledge and in vivo data on pharmacokinetics/pharmacodynamics relationships.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 91, December 2017, Pages 249-256
نویسندگان
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