کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
8514285 1556506 2017 42 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Medicines for Pediatric Patients-Biopharmaceutical, Developmental, and Regulatory Considerations
ترجمه فارسی عنوان
داروها برای بیماران کودکان - داروهای بیولوژیکی، رشد، و مقررات قانونی
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
چکیده انگلیسی
This commentary reflects current developments in pediatric medicine. The underpinning legislation in both Europe and the United States has led to the initiation of an increased number of clinical trials in the pediatric population, but there are still a number of outstanding issues within this field. These include the differences in the physiology between adults and the very heterogeneous nature of pediatric patients. There is an ongoing scientific debate on the applicability of a Pediatric Biopharmaceutical Classification System to define when waivers for bioequivalence studies can be supported by in vitro dissolution. However, a challenge is that in vitro models should adequately mimic the physiology of different pediatric age-groups and dose definition is another critical aspect. There is a tendency for off-label use of established adult medicines, resulting in increased adverse events and decreased efficacy in the target population. Recent advances in physiologically based pharmacokinetic modelling may be used to provide valuable input into these discussions, but there are currently still many knowledge gaps. It is encouraging that there is a global recognition of these deficiencies and substantial funding in the field of basic research is being provided, for example, within Europe the Innovative Medicines Initiative consortium.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 106, Issue 4, April 2017, Pages 950-960
نویسندگان
, , ,