Background: Spontaneous viral clearance occurs in 10% to 40% of individuals after hepatitis C virus infection. Some polymorphisms in IL-28B gene may influence the outcome of HCV infection. The present study aimed at investigating the genotype and allele frequency of IL-28B rs12979860 and rs8099917 SNPs in HCV infected patients in addition to determining their association with disease outcome. Methods: A total of 302 patients with chronic hepatic C infection and 36 individuals whose infection was spontaneously cleared were included in this case-control study. The presences of chronic or spontaneously cleared infection in participants were determined by serologic and molecular methods. Genomic DNA of the participants was extracted using salting out method. IL-28B/IFN-λ3 gene polymorphisms were conducted using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Results: The frequency of CC genotype (P = 0.001) and C allele (P = 0.0007) of IL-28B gene at rs12979860 SNP was significantly higher in participants with spontaneously cleared HCV infection compared to that of those who were chronically infected. In the case of rs8099917 SNP of IL-28B, no correlation was found between frequency of genotype (P = 0.17) or allele (P = 0.12) and HCV infection outcome. The results of haplotype analysis showed the association of CT (P = 0.012) and TT (P = 0.013) haplotypes with spontaneous clearance and chronic infection, respectively. Conclusions: The findings implied that individuals with CC or CT genotype at rs12979860 SNP but rs8099917 SNP was not in association with spontaneous clearance of HCV in an Iranian population with HCV infection.

A randomized, two-way, crossover study was conducted in 15 fasting, healthy, Algerian volunteers to compare the bioavailability of two brands of Valsartan 80 mg coated breakable tablets. The present study aimed to evaluate the intra-subject variability of this active substance in the Algerian population. The test brand was compared to TAREG (Novartis) as the reference product. The study was performed at the bioequivalence center of the national control laboratory for pharmaceuticals products, in joint venture with University Hospital Center Ibn Badis, Constantine, Algeria. The drug was administered with 200 mL of water after a 10 h overnight fasting on two treatment days separated by one week washout period. After dosing, serial blood samples were collected for a period of 24 h. A reliable, simple, and robust liquid chromatography-tandem mass spectro-metric (LC-MS/MS) method has been developed and validated that employs protein precipitation (or denaturation) for the estimation of valsartan in human plasma using losartan as internal standard. The assay was found to be linear over the range of 50-5,000 ng/mL, with a lower limit of quantitation of 50ng/mL. Various pharmacokinetic parameters including AUC0 -t , AUC0 -∞ , C max , T max , and T 1/2 were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. The pharmacokinetical and statistical analysis was conducted with Kinetica 4.4.1. AUC 0-t , AUC 0-∞ and C max were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval ([85.82%, 118.76%] for AUC 0-t [86.09%, 118.83%] for AUC 0-∞ ) of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80-125%. But for the C max , the 90% confidence interval of test/reference ratio wasn't in this acceptance range [90.18%, 131.07%] .The results of PK analysis suggested that the reference and test formulations of valsartan 80 mg coated breakable tablets weren't bioequivalent during fasting state in these healthy algerian volunteers.

A randomized, two-way, crossover study was conducted in 18 fasting, healthy, algerian volunteers to compare the bioavailability of two brands of Omeprazole 20 mg Gastro-Resistant Capsules where MOPRAL (Astra Zeneca) was the reference product. The study was performed at the bioequivalence center of the national control laboratory for pharmaceuticals product. The drug was administered on two treatment days separated by one week washout period. After dosing, serial blood samples were collected for a period of 12 h. A reliable and robust LC-MS/MS (liquid chromatography-tandem mass spectrometry) method has been developed and validated for the estimation of Omeprazole in human plasma. The assay was found to be linear over the range of 5-1,000 ng/mL. The pharmacokinetical and statistical analysis was conducted with Kinetica 4.4.1. AUC 0-t , AUC 0-∞ and C max were tested for bioequivalence. No significant difference was found based on ANOVA; 90% confidence interval ([97.14%-117..85%] for AUC 0-t , [97.17%-117.67%] for AUC 0-∞ ) of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80%-125%. But for the C max , it was not in this acceptance range [73.5%-100.54%]. The results of PK analysis suggested that the reference and test formulations of Omeprazole 20 mg Gastro-Resistant Capsules were not bioequivalent during fasting state in these healthy Algerian volunteers.