Đánh giá tương đương sinh học viên nén atenolol 100mg do acaông ty cổ phần pymepharcosanr xuất

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Tác giả: Thị Cẩm Tú Cao, Lý Hải Anh Chu, Ngọc Nãi Chương, Thị Quỳnh Chi Trần, Thị Phương Lan Trịnh

Ngôn ngữ: vie

Ký hiệu phân loại: 615.1 Drugs (Materia medica)

Thông tin xuất bản: Dược học, 2012

Mô tả vật lý: 45578

Bộ sưu tập: Metadata

ID: 627679

Bioequivalence of two oral formulations of Atenolol 100 mg was studied in 24 healthy volunteers by a single-dose, two-treatment, twoperiod, randomized, crossover design with a one-week washout period between the two phases of the study and under fasting condition. After dosing, serial blood samples were collected for a period of 36 hours. Plasma harvested from blood was analyzed for atenolol by a sensitive, selective, reproducible and accurate LC - MS/MS method. Various pharmacokinetic parameters including AUC0-1, AUC0-~, Cmax, Tmax and T1/2 were determined for the both formulations by its plasma concentrations. 90 percent confidence interval for test/reference ratio of AUCo-~. Cmax were found within acceptance range of 80-125 percent. Based on these statistical inferences, the two formulations were of acceptable bioequivalence.
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