کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2484376 1114309 2015 14 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 2: Topical Drug Product
ترجمه فارسی عنوان
اثرات عکسبرداری در استفاده: راهنمای پیشنهادی برای تست و برچسب گذاری عکسبرداری برای حمایت از اداره محصولات دارویی حساس به نور، قسمت 2: محصولات دارویی موضعی
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
چکیده انگلیسی

ABSTRACT:Although essential guidance to cover the photostability testing of pharmaceuticals for manufacturing and storage is well-established, there continues to be a significant gap in guidance regarding testing to support the effective administration of photosensitive drug products. Continuing from Part 1, (Baertschi SW, Clapham D, Foti C, Jansen PJ, Kristensen S, Reed RA, Templeton AC, Tønnesen HH. 2013. J Pharm Sci 102:3888–3899) where the focus was drug products administered by injection, this commentary proposes guidance for testing topical drug products in order to support administration. As with the previous commentary, the approach taken is to examine “worst case” photoexposure scenarios in comparison with ICH testing conditions to provide practical guidance for the safe and effective administration of photosensitive topical drug products.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 104, Issue 9, September 2015, Pages 2688–2701
نویسندگان
, , , , , , , ,