کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10162244 | 1114324 | 2014 | 21 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance
ترجمه فارسی عنوان
نقشه راه برای ارزیابی ریسک بیوفرم دارایی برای بهینه سازی عملکرد محصولات بالینی
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کلمات کلیدی
Clinical trial simulationsOral drug delivery - تحویل داروی خوراکیControlled delivery - تحویل کنترل شدهIn silico modeling - در مدل سازی سیلیکاBiopharmaceutics Classification System (BCS) - سیستم طبقه بندی بیولوژیک (BCS)Pharmacodynamics - فارماکودینامیکPharmacokinetics - فارماکوکینتیکBioavailability - فراهم زیستیIn vitro models - مدل های in vitroin vitro/in vivo correlations (IVIVC) - همبستگی in vitro / in vivo (IVIVC)Quality by design (QbD) - کیفیت با طراحی (QbD)
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
چکیده انگلیسی
The biopharmaceutics risk assessment roadmap (BioRAM) optimizes drug product development and performance by using therapyâdriven target drug delivery profiles as a framework to achieve the desired therapeutic outcome. Hence, clinical relevance is directly built into early formulation development. Biopharmaceutics tools are used to identify and address potential challenges to optimize the drug product for patient benefit. For illustration, BioRAM is applied to four relatively common therapyâdriven drug delivery scenarios: rapid therapeutic onset, multiphasic delivery, delayed therapeutic onset, and maintenance of target exposure. BioRAM considers the therapeutic target with the drug substance characteristics and enables collection of critical knowledge for development of a dosage form that can perform consistently for meeting the patient's needs. Accordingly, the key factors are identified and in vitro, in vivo, and in silico modeling and simulation techniques are used to elucidate the optimal drug delivery rate and pattern. BioRAM enables (1) feasibility assessment for the dosage form, (2) development and conduct of appropriate “learning and confirming” studies, (3) transparency in decisionâmaking, (4) assurance of drug product quality during lifecycle management, and (5) development of robust linkages between the desired clinical outcome and the necessary product quality attributes for inclusion in the quality target product profile. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:3377-3397, 2014
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 11, November 2014, Pages 3377-3397
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 11, November 2014, Pages 3377-3397
نویسندگان
Arzu Selen, Paul A. Dickinson, Anette Müllertz, John R. Crison, Hitesh B. Mistry, Maria T. Cruañes, Marilyn N. Martinez, Hans Lennernäs, Tim L. Wigal, David C. Swinney, James E. Polli, Abu T.M. Serajuddin, Jack A. Cook, Jennifer B. Dressman,