A Bioequivalence Study With Pharmacokinetic Endpoints for Azithromycin Eye Drops.
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DOI: 10.1002/cpdd.1226
Abstract: Azithromycin eye drops with a bioadhesive ocular drug-delivery system can offer a simplified dosing regimen. In this study, we compared the pharmacokinetic properties and assessed the bioequivalence of a newly developed generic azithromycin eye drop… read more here.
Keywords: bioequivalence; azithromycin eye; bioequivalence study; eye drops ... See more keywords
Pharmacokinetics and Bioequivalence Study of a New Branded Generic Moxifloxacin Tablet Among Healthy Volunteers.
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DOI: 10.1002/cpdd.964
Abstract: A newly developed branded generic of a moxifloxacin (MOX) 400-mg tablet formulation was manufactured prior to this study. A bioequivalence (BE) study was done to assess the pharmacokinetics of the formulation using a randomized, open-label,… read more here.
Keywords: branded generic; formulation; generic moxifloxacin; bioequivalence study ... See more keywords
Sensitive LC-MS/MS Method for the Determination of Ramipril in Human Plasma: Application to a Bioequivalence Study in Indian Volunteers
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DOI: 10.1007/s12247-017-9272-2
Abstract: PurposeSensitive and selective analytical method is required for the estimation of ramipril in human plasma as ramipril has been reported to have high intra-subject variability and phase II inactive metabolite (ramipril acyl glucuronide) back-converted to… read more here.
Keywords: human plasma; ramipril human; determination ramipril; bioequivalence study ... See more keywords
In Silico Modeling and Simulation to Guide Bioequivalence Testing for Oral Drugs in a Virtual Population
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DOI: 10.1007/s40262-021-01045-7
Abstract: Model-informed drug discovery and development (MID3) shows great advantages in facilitating drug development. A physiologically based pharmacokinetic model is one of the powerful computational approaches of MID3, and the emerging field of virtual bioequivalence is… read more here.
Keywords: bioequivalence; virtual bioequivalence; oral drugs; silico modeling ... See more keywords
An improved LC-MS/MS method for the quantification of alverine and para hydroxy alverine in human plasma for a bioequivalence study☆☆
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DOI: 10.1016/j.jpha.2016.11.003
Abstract: A highly sensitive and selective high performance liquid chromatography-tandem mass spectrometry method was developed and validated for the quantification of alverine (ALV) and its active metabolite, para hydroxy alverine (PHA), in human plasma. For sample… read more here.
Keywords: para hydroxy; human plasma; bioequivalence study; quantification alverine ... See more keywords
Application of an LC–MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study
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DOI: 10.1016/j.jpha.2017.06.001
Abstract: A sensitive and selective method has been proposed for the simultaneous determination of amlodipine (AML), valsartan (VAL) and hydrochlorothiazide (HCTZ) in human plasma by liquid chromatography–tandem mass spectrometry (LC–MS/MS). The analytes and their deuterated analogs… read more here.
Keywords: valsartan; val; method; hctz ... See more keywords
Highly sensitive LC–MS/MS method to estimate doxepin and its metabolite nordoxepin in human plasma for a bioequivalence study
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DOI: 10.1016/j.jpha.2017.06.004
Abstract: A selective, sensitive and rugged liquid chromatography–tandem mass spectrometry (LC–MS/MS) assay has been developed for the simultaneous determination of doxepin (Dox) and its pharmacologically active metabolite, nordoxepin (NDox) in human plasma. The analytes and their… read more here.
Keywords: plasma; doxepin; metabolite nordoxepin; human plasma ... See more keywords
Quantitative analysis of valsartan by two-dimensional liquid chromatography (2D-HPLC) and its application in a bioequivalence study in Chinese volunteers .
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DOI: 10.5414/cp202762
Abstract: PURPOSE To develop a sensitive, two-dimensional liquid chromatography (2D-LC) method for determination of valsartan, applied to investigate bioequivalence of two valsartan tablets in Chinese volunteers under fasting condition. METHODS A full automatic 2D-HPLC system was… read more here.
Keywords: bioequivalence; hplc; valsartan; bioequivalence study ... See more keywords