Drug Interchangeability of Generic and Brand Products of Fixed Dose Combination Tablets of Sofosbuvir and Ledipasvir (400/90 mg): Employment of Reference Scaled Average Bioequivalence Study on Healthy Egyptian Volunteers

Bendas Ehab Rasmy; Rezk Mamdouh R.; Badr Kamal A.

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Drug Interchangeability of Generic and Brand Products of Fixed Dose Combination Tablets of Sofosbuvir and Ledipasvir (400/90 mg): Employment of Reference Scaled Average Bioequivalence Study on Healthy Egyptian Volunteers

机译：Sofosbuvir和Ledipasvir的固定剂量组合片剂（400/90 mg）的仿制剂和品牌产品的药物互换性：参考的参考普通生物等效性研究健康埃及志愿者

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Background and Objectives The purpose of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence and to investigate the pharmacokinetic properties of two formulations of fixed dose combination (FDC) tablet of sofosbuvir (SOF) and ledipasvir (LED) (400/90 mg) in 36 healthy Egyptian volunteers.

机译：背景和目标本研究的目的是应用参考缩放的平均生物等效（RSABE）方法来评估生物等效性，并研究Sofosbuvir（SOF）和LEDIPASVIR的固定剂量组合（FDC）片剂的两种配方的药代动力学特性（ LED）（400/90 mg）在36名健康的埃及志愿者中。

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《Clinical drug investigation》 |2018年第5期|共10页
作者
Bendas Ehab Rasmy; Rezk Mamdouh R.; Badr Kamal A.;
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作者单位

Future Univ Egypt Fac Pharmaceut Sci &

Pharmaceut Ind Clin Pharm Dept Cairo Egypt;

Cairo Univ Fac Pharm Analyt Chem Dept Kasr El Aini St Cairo 11562 Egypt;

Deraya Univ Dept Pharmaceut Fac Pharm Al Minya Egypt;

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原文格式 PDF
正文语种 eng
中图分类药学;
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1. Drug Interchangeability of Generic and Brand Products of Fixed Dose Combination Tablets of Sofosbuvir and Ledipasvir (400/90 mg): Employment of Reference Scaled Average Bioequivalence Study on Healthy Egyptian Volunteers [J] . Bendas Ehab Rasmy, Rezk Mamdouh R., Badr Kamal A. Clinical drug investigation . 2018,第5期

机译：Sofosbuvir和Ledipasvir的固定剂量组合片剂（400/90 mg）的仿制剂和品牌产品的药物互换性：参考的参考普通生物等效性研究健康埃及志愿者
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3. Pharmacokinetic Properties and Bioequivalence of Two Sulfadoxine/Pyrimethamine Fixed-Dose Combination Tablets: A Parallel-Design Study in Healthy Chinese Male Volunteers [J] . LiuY.-M., ZhangK.E., LiuY., Clinical therapeutics . 2012,第11期

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Drug Interchangeability of Generic and Brand Products of Fixed Dose Combination Tablets of Sofosbuvir and Ledipasvir (400/90 mg): Employment of Reference Scaled Average Bioequivalence Study on Healthy Egyptian Volunteers

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