Challenges and Opportunities in Achieving Bioequivalence for Fixed-Dose Combination Products
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چکیده
منابع مشابه
A replicate designed bioequivalence study to compare two fixed-dose combination products of artesunate and amodiaquine in healthy chinese volunteers.
Artesun-Plus is a fixed-dose combination antimalarial agent containing artesunate and amodiaquine. The current study was conducted to compare the pharmacokinetic and safety profiles of Artesun-Plus and the WHO-designated comparator product Artesunate Amodiaquine Winthrop. To overcome the high intrasubject variability of artesunate, the study applied a two-sequence and four-period crossover (2 b...
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ژورنال
عنوان ژورنال: The AAPS Journal
سال: 2012
ISSN: 1550-7416
DOI: 10.1208/s12248-012-9378-x