Volume 27, Issue 108 (2-2019)                   jour guilan uni med sci 2019, 27(108): 35-44 | Back to browse issues page

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Aboutaleb E, Manoochehri S. Bioequiwin: Design of a Bioequivalence Software. jour guilan uni med sci. 2019; 27 (108) :35-44
URL: http://journal.gums.ac.ir/article-1-1755-en.html
Abstract:   (259 Views)
Abstract
Introduction: Bioequivalence studies are the most important way of evaluating the quality and efficacy of pharmaceutical formulations. In a bioequivalence study, the rate and extent of drug absorption into the general circulation is measured and the pharmacokinetic parameters should be calculated and statistically evaluated for the reference and test products. Pharmacokinetic parameters such as Cmax, Tmax, AUC, and Kel are the principles to determine the rate extent of drug entry into the bloodstream, which are achieved from complex calculations over the initial blood concentrations. Complex pharmacokinetic and statistical calculations parameters from these studies are the most important challenges in these types of studies which leads to an interpretation of the wrong results. In the present study, a software was designed for this type of calculations. The user interface is easy for researchers and may be used without engaging the operator in pharmacokinetic and statistical processes.
Objective: Design a domestic, easy and user-friendly software to help implement biequivalence studies.
Materials and Methods: Microsoft Visual Basic 14 was utilized in order to create the software and its main scientific reference guide was the FDA Guidance for Industry for Bioavailability and Bioequivalence Studies.
Conclusion: The present software can be used as a complete package for bioequivalence studies.
Conflict of interest: non declared
Full-Text [PDF 697 kb]   (101 Downloads)    
Type of Study: Research | Subject: Special
Received: 2019/01/27 | Accepted: 2019/01/27 | Published: 2019/01/27

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