Despite the progress of pharmacology and modern clinical medicine, the problem of pain therapy remains an urgent medical and social problem.
The purpose was to assess the impact of the use of a chiral bioanalytical method on the conclusions of a bioequivalence study that compared two ibuprofen suspensions with different rates of absorption.
C(max) reached values of 23.71 microg/ml for test and 23.32 microg/ml (geometric means) for the reference. 192 0 obj << /Linearized 1 /O 194 /H [ 671 871 ] /L 133227 /E 5285 /N 48 /T 129268 >> endobj xref 192 11 0000000016 00000 n FDA requires that bioequivalence studies be performed to claim that these multiple tablets of smaller dose are bioequivalent to a single tablet of the higher dose.Generic drugs contribute to modern healthcare by accomplishing effective, safe, and low- cost alternatives to currently available modern medicines….With 15+ years experience in bioequivalence and bioavailability studies, our team at NorthEast BioLab leads the pack in benchmarking and reviewing internal standard operating procedures to keep pace with the dynamic regulatory environment. Two metabolites have been isolated and identified in the urine of the three species. Both Km and Vmax decreased by increasing the drug concentration. Blood samples for pharmacokinetic profiling were taken up to 14 h post-dose, and clindamycin plasma concentrations were determined with a validated liquid chromatography-electrospray ionization-mass spectrometry (LC-ESI-MS) method. selected volunteers were divided into two groups of 12 subjects. Results. For this purpose a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers.
Results. Georg Thieme Verlag Stuttgart, New York
Method: This bioequivalence trial was based on an open-label, single-dose, randomized, two-treatment, two-period crossover design. Bioequivalence establishes generic drugs as interchangeable to the branded ones with similar therapeutic and side effect profiles. The validated method was applied successfully to a bioequivalence study of PAR/MET (500/400 mg) fixed dose combination tablet in healthy volunteers (n=24).In bioequivalence assessment, the consumer risk of erroneously accepting bioequivalence is of primary concern. Bioequivalence assessment between 2 sources of a drug product can be evaluated by 4 methods in order of preference: pharmacokinetic, pharmacodynamic, comparative clinical trials, or in vitro studies. 1 Pharmacokinetic evaluation of the active drug in the circulating blood of healthy human patients is the method of choice for bioequivalence assessment of systemic drug products. The purity and manufacturing process of the final product, however, still must be evaluated separately.The pharmacokinetic method for assessing the bioavailability of drugs is an indirect method which traces the path of medication from absorption in the body until its excretion. A single post oral dose of each formulation was given to 14 male healthy volunteers. 2008 Oct;30(10):1831-43. doi: 10.1016/j.clinthera.2008.10.010.Almeida S, Filipe A, Neves R, Pinho C, Pedroso P, Castillo A, Trabelsi F.Arzneimittelforschung. 2011;61(1):32-9. doi: 10.1055/s-0031-1296165.Palma-Aguirre JA, Villalpando-Hernández J, Novoa-Heckel G, Oliva I, Cariño L, López-Bojórquez E, Burke-Fraga V, Namur S, González-de la Parra M.Clin Ther. The pharmacokinetic parameters AUC(0-24), AUC(0-infinity), C(max), T(max), K(e) and T1/2 were determined for both formulations and were compared statistically to evaluate the bioequivalence betwee the two brands of cefdinir, using the statistical model recommended by the FDA. Typically, high bioavailability is desirable, but in some cases, low bioavailability is beneficial if the drug is administered directly to the site of action, or there are concerns about systemic toxicity.Bioequivalence requirements from the US FDA and other agencies entail the comparability of new formulations and generics to products approved already to maintain existing standards of safety and efficacy. Methods. The causes of musculoskeletal pain are various diseases of the musculoskeletal system, including osteoporosis, osteochondrosis, arthritis, bone tumors, myalgia, etc. Methocarbamol is characterized by a favorable safety profile when administered either orally or in injectable form. In this study, the effect of methocarbamol on the peroxidase activity of human hemoglobin was investigated. The in-vivo bioavailability of a drug product is demonstrated In the therapeutic assessment, we test the relationship between the clinical response when the drug concentration moves to the site of action (or reacts to the symptoms it intends to cure). In each period 32 male or female healthy white volunteers received 2 tablets (2 x 750 mg methocarbamol) of either the test (a) or the reference (b) … The 90% confidence interval for the ratio of the logarithmically transformed AUC(0-t), AUC(0-infinity) and Cmax were within the bioequivalence limit of 0.8-1.25 and the relative bioavailability of the test formulation was 96.62% of that of the reference formulation.
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