Azithromycin, 9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin a dihydrate, is a semi-synthetic 15-membered azalide antibiotics derived from erythromycin. Its chemical structure differs from that of erythromycin by the insertion of methyl-substituted nitrogen at position 9a in the lactone ring. This modification results in the improved acid stability associated with more reliable and greater oral b...

The demand to get a tool for biological parameter estimation of new compounds for clinical application, supports the postulation of predictive models as an alternative to conventional classical assays being no necessary the use of experimentation in animals. A lot of in vitro systems, including the use of physicochemical parameters of drugs, the permeability data from cell culture line and the ...

Oxycodone is a semisynthetic opioid used for the treatment of moderate to severe pain. Two separate studies were conducted to assess the pharmacokinetic bioequivalence of a newly formulated oxycodone hydrochloride extended-release tablet to a marketed oxycodone product in Japan under fasting and fed conditions. Each study was a randomized, open-label, single-dose, single-center, two-period, two...

The aim of present study was to compare the quality of atenolol tablets and examine the possibility of biowaiver study for approval of generic drugs without additional in vivo bioequivalence study. Atenolol, a cardio selective β-blocker, could be clearly classified into BCS Class III and may be evaluated under biowaiver conditions. Due to the importance of atenolol and availability of different...

Abstract Background Vildagliptin is a dipeptidyl peptidase-4 inhibitor used to treat diabetes mellitus. No bioequivalence study data have been published for the Indian population comparing of vildagliptin brands Galvus, Zomelis, and Jalra. This aimed evaluate between three 50 mg tablet (test 1, Zomelis; test 2, Jalra; reference, Galvus) compare these formulations with reference formulation meet...

11 # Corresponding author. Mailing address: Vivo Development Ltd, 1559 Zu Chong Zhi Road, 12 Suite 1002, Shanghai, China 201203. Phone: +86 21 50275348, Fax: +86 21 20253076, email: 13 [email protected] 14 15 Running Title: ASAQ replicate designed bioequivalence study. 16 17

This study was aimed to investigate bioequivalence of modified-release 30 mg gliclazide tablets in 18 healthy Thai volunteers. A test product, Glycon MR (Siam Bheasach, TH), was compared with a reference product, Diamicron MR (Servier, France). The study was performed under a single-dose, two-treatment, two-period, and two-sequence crossover design in fasted and fed conditions with a washout pe...