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Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1112
Abstract: The main objective of the study was to evaluate the bioequivalence of two rosuvastatin calcium tablets in healthy Chinese subjects under fasted and fed conditions. The study was carried out using a randomized, open‐label, two‐formulation,…
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Keywords:
single dose;
fasted fed;
fed conditions;
bioequivalence ... See more keywords
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Published in 2017 at "Advances in Therapy"
DOI: 10.1007/s12325-017-0594-8
Abstract: AbstractIntroduction Pirfenidone film-coated tablets were developed to offer an alternative to the marketed capsule formulation. This study assessed the bioequivalence of the tablet and capsule formulations under fed and fasted states.MethodsA Phase I, open-label, randomized,…
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Keywords:
bioequivalence;
state;
auc0;
capsule ... See more keywords
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Published in 2021 at "Journal of Antimicrobial Chemotherapy"
DOI: 10.1093/jac/dkab057
Abstract: Abstract Background Early detection and correction of low fluoroquinolone exposure may improve treatment of MDR-TB. Objectives To explore a recently developed portable, battery-powered, UV spectrophotometer for measuring levofloxacin in saliva of people treated for MDR-TB.…
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Keywords:
saliva;
auc0;
levofloxacin;
serum ... See more keywords
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Published in 2019 at "Therapeutic Drug Monitoring"
DOI: 10.1097/ftd.0000000000000658
Abstract: Background: Mycophenolate mofetil or enteric-coated mycophenolate sodium (EC-MPS) and steroids are used for induction and maintenance therapy in severe lupus nephritis. Blood concentrations of mycophenolic acid (MPA), the active metabolite of these drugs, vary among…
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Keywords:
enteric coated;
coated mycophenolate;
lupus nephritis;
auc0 ... See more keywords
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Published in 2021 at "International Journal of Applied Pharmaceutics"
DOI: 10.22159/ijap.2021v13i4.41331
Abstract: Objective: The present study's objective is to conduct a comparative bioavailability study with a special emphasis on the test product's bioequivalence using a standard reference product as a comparator. Methods: Before initiating the bioequivalent study,…
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Keywords:
study;
product;
auc0;
bioequivalence ... See more keywords
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Published in 2019 at "International journal of clinical pharmacology and therapeutics"
DOI: 10.5414/cp203437
Abstract: OBJECTIVE This study was conducted to evaluate the pharmacokinetic properties and bioequivalence of two oral formulations of canagliflozin: a newly developed generic formulation (test) and a branded formulation (reference). MATERIALS AND METHODS A randomized, open-label,…
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Keywords:
healthy chinese;
oral formulations;
bioequivalence two;
auc0 ... See more keywords
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Published in 2023 at "International journal of clinical pharmacology and therapeutics"
DOI: 10.5414/cp204309
Abstract: BACKGROUND Domperidone has long been used as a prokinetic agent in the treatment of epigastric distress symptoms. This study aimed to provide adequate evidence for registration approval of a new generic dry suspension formulation of…
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Keywords:
fasted fed;
domperidone;
bioequivalence;
auc0 ... See more keywords