کد مقاله کد نشریه سال انتشار مقاله انگلیسی ترجمه فارسی نسخه تمام متن
2484355 1114308 2016 9 صفحه PDF سفارش دهید دانلود رایگان
عنوان انگلیسی مقاله ISI
Quality by Design Approaches to Formulation Robustness-An Antibody Case Study
ترجمه فارسی عنوان
کیفیت با رویکردهای طراحی به تدوین استحکام، مطالعه موردی آنتی بادی
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موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
چکیده انگلیسی
The International Conference on Harmonization Q8 (R2) includes a requirement that “Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can impact the quality of the drug product,” that is, the need to assess the robustness of a formulation. In this article, a quality-by-design-based definition of a “robust formulation” for a biopharmaceutical product is proposed and illustrated with a case study. A multivariate formulation robustness study was performed for a selected formulation of a monoclonal antibody to demonstrate acceptable quality at the target composition as well as at the edges of the allowable composition ranges and fulfillment of the end-of-shelf-life stability requirements of 36 months at the intended storage temperature (2°C-8°C). Extrapolation of 24 months' formulation robustness data to end of shelf life showed that the MAb formulation was robust within the claimed formulation composition ranges. Based on this case study, we propose that a formulation can be claimed as “robust” if all drug substance and drug product critical quality attributes remain within their respective end-of-shelf-life critical quality attribute-acceptance criteria throughout the entire claimed formulation composition range.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 105, Issue 5, May 2016, Pages 1667-1675
نویسندگان
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