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“Two studies were conducted in order to assess the bioequivalence of montelukast (CAS
151767-02-1) 10 mg film-coated tablet (FCT) and 5 mg chewable tablet (CT) test formulations in comparison with the original brands. Under fasting conditions, healthy male and female volunteers received one 10 mg FCT or 5 mg CT orally as a single dose of a test or reference formulation. Both studies were designed as open-label, randomized, two-period, two-sequence, crossover studies with a 7-day washout interval. Plasma samples were collected up to 24 h after drug administration and montelukast levels were determined by a validated LC/MS/MS method. Pharmacokinetic parameters were calculated using non-compartmental analysis and were statistically compared Selleckchem VX-689 by analysis of variance for test and reference formulation. Bioequivalence between products was determined by calculating 90% confidence GSK J4 in vivo interval of the ratio test/reference of least-square means of logarithmically
transformed C(max) and AUC(0-t) parameters. AUC(0-infinity) was also analysed to obtain additional information. The calculated 90% confidence intervals for the ratios of C(max) and AUC(0-t) parameters were 89.33-110.52 and 92.06-109.46, respectively, in the FCT study, and 91.58-101.86 and 92.15-98.83, respectively, in the CT study, which are all within the bioequivalence acceptance range of 80-125%. Based on the results, it can be concluded that the evaluated test FCT and CT formulations are bioequivalent to their respective reference formulation in terms of rate and extent of absorption.”
“Objective: To present the anatomical and functional results of the inside-out technique applied in pediatric cholestetaoma surgery and to evaluate functionality with good hearing results against radicality with lower recurrence rate.
Methods: Retrospective analysis and evaluation of the postoperative outcome in a consecutive series of 126 children or
130 ears operated between 1992 and 2008. With the inside-out AP24534 mouse technique, cholesteatoma is eradicated from the epitympanum toward the mastoid and, as a single stage procedure, functional reconstruction of the middle ear is achieved by tympanoossiculoplasty.
Results: In 89.2% of all cases, the ear was dry postoperatively. 80.9% of the ears reached a postoperative air-bone gap of 30 dB or less and the median air conduction hearing threshold was 29 dB; in 60.9% of all cases, hearing was postoperatively improved. The recurrence rate was 16.2% in a mean postoperative follow-up 8.5 years. Altogether, 48 ears (36.9%) underwent revision surgery. The complication rate was 3.1% and involved only minor complications.
Conclusion: The inside-out technique allows a safe removal of cholesteatoma from the epitympanum toward the mastoid with a single-stage reconstruction of the ossicular chain.