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Rachna Arora,Manju Sharma,Tausif Monif,Sunil Iyer 대한암학회 2016 Cancer Research and Treatment Vol.48 No.3
Purpose This study was designed to characterize the pharmacokinetic profile and to assess bioequivalence of the sponsor’s test formulation (imatinib mesylate 400 mg tablets) with an innovator product (Gleevec 400 mg tablets, Novartis Pharmaceuticals) under fed conditions, in adult patients of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) stabilized on imatinib mesylate 400 mg. In addition, the aim of this study was to monitor the safety profile of investigational medicinal products (IMPs). Materials and Methods A multicenter, randomized, open label, two-period, crossover, single dose bioequivalence study was designed for conduct under fed conditions in 42 adult Ph+ CML patients already stabilized on imatinib 400 mg tablets. Pharmacokinetic parameters Tmax, Cmax, and AUC0-24 were calculated using a non-compartmental model on validated WinNonlin software. Validated SAS software was used for statistical evaluation of data. The safety profile of investigational products was monitored during the course of study by applying a clinical process for recording observed untoward effects postadministration of investigational products. Results The 90% confidence intervals for the test/reference mean ratios of the ln-transformed PK variables Cmax (99.0%) and AUC0-24 (99.2%) were within an acceptable range of 80%-125%, as per bioequivalence assumptions. Both formulations were well tolerated after oral administration of IMPs. Conclusion The test product was found to be bioequivalent and safe, and thus can be used interchangeably in clinical practice.
Radioprotective and Antioxidant Activity of Fractionated Extracts of Berries of Hippophae rhamnoides
Rakesh Kumar Sharma,Raman Chawla,Rajesh Arora,Shikha Singh,Ravinder Kumar Sagar,Raj Kumar,Ashok Sharma,Manju L. Gupta,Surender Singh,Jagdish Prasad,Haider A. Khan,Anand Swaroop,A.K. Sinha,A.K. Gupta,R 한국식품영양과학회 2007 Journal of medicinal food Vol.10 No.1
Plants are an abundant source of medicinal compounds, some of which are useful in combating free radical-1002 (flavonoid-poor fraction) of Hippophae rhamnoideswere screened on the basis of their reducing power in the aqueousphase. REC-1001 was selected for further study, since it exhibited 27.38 times higher antioxidant activity than REC-1002.REC-1001 also showed significant (P. .05) membrane protection potential at 50 .g/mL, which was attributed to its abilityto scavenge peroxyl radicals (64.82. 1.25% scavenging within 1,440 min). A significant (P. .05) difference of 67.02% infree radical scavenging activity at 1,000 ng/mL between REC-1001 and vitamin E demonstrated the extract fraction’s worthc-tion. Further, REC-1001 was found to be nontoxic up to 200 mg/kg of body weight. This research suggests that the REC-1001 fraction of H. rhamnoidesextract is a safe and effective antioxidant nutraceutical product.