Physiologically Based Biopharmaceutics Modeling of Food Effect for Basmisanil: A Retrospective Case Study of the Utility for Formulation Bridging [PDF]
Pharmaceutics, 2023 Basmisanil, is a lipophilic drug substance, exhibiting poor solubility and good permeability (BCS class 2). A validated physiologically based biopharmaceutics model (PBBM) has been previously described for tablets dosed in the fed state.
Tejashree Belubbi +3 more
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Development and Validation a UPLC-MS/MS Method for Quantification of Pentoxifylline in Beagle Plasma: Application for Pharmacokinetic Study of Food Effect [PDF]
Drug Design, Development and Therapy, 2023 Yuxiang Xu, Xiaonan Gao, Yunfang Zhu, Qi Zhang, Hongxin Qie, Haopeng Zhao, Jinglin Gao, Mingxia Wang Department of Clinical Pharmacology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, People’s Republic of ChinaCorrespondence ...
Xu Y +7 more
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Consideration on Food Effect Studies for Anticancer Drugs Approved in Japan Between 2001 and 2022 [PDF]
Clinical and Translational ScienceIn developing a new drug, studies to evaluate the food effect (FE) on the drug's pharmacokinetics (FE studies) are generally conducted in healthy subjects in the early stages of clinical development.
Maho Shibuya +2 more
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Food Effect and Formulation: How Soluble Fillers Affect the Disintegration and Dissolution of Tablets in Viscous Simulated Fed State Media [PDF]
PharmaceuticsThe food-induced viscosity of the media can alter tablet disintegration and eventually the release of the drug it contains. The extent of this retardation depends on tablet formulation factors, such as the solubility of its excipients.
Muhammad Farooq Umer +8 more
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A randomized, open-label, two-period crossover study to evaluate the bioequivalence and food effect between two formulations of regorafenib in healthy adult participants [PDF]
Frontiers in PharmacologyBackgroundThis research aimed to compare the bioequivalence of a test formulation (regorafenib produced by Beijing SL Pharmaceutical Co., Ltd.) with a reference formulation (the original drug Stivarga®) in Chinese healthy subjects under fasting ...
Yan Li +4 more
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Calcium Absorption from Food Products: Food Matrix Effects [PDF]
Nutrients, 2021 This article reviews physicochemical aspects of calcium absorption from foods. Notable differences are observed between different food products in relation to calcium absorption, which range from <10% to >50% of calcium in the foods. These differences can be related to the interactions of calcium with other food components in the food matrix ...
Shkembi, Blerina, Huppertz, Thom
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Diets, Foods and Food Components’ Effect on Dyslipidemia [PDF]
Nutrients, 2021 Hypercholesterolemia is a well-known independent risk factor for cardiovascular disease and a recognized target of pharmacological therapeutic agents in both primary and secondary prevention [...]
Federica Fogacci +2 more
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Annals of Medicine, 2023 Background: TQA3526 is a novel farnesoid X receptor agonist developed to treat non-alcoholic steatohepatitis (NASH) or primary biliary cholangitis (PBC).
Jia Xu +9 more
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Frontiers in Immunology, 2023 BackgroundGolidocitinib is an orally available, potent and highly selective JAK (Janus kinase)-1 inhibitor of JAK/STAT3 signaling under clinical development for the treatment of cancer and autoimmune diseases.
Kan Chen +11 more
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Pharmaceutics, 2023 A strategy followed to integrate in vitro solubility and permeability data into a PBBM model to predict the food effect of a BCS IV zwitterionic drug (GSK3640254) observed in clinical studies is described.
Konstantinos Stamatopoulos +6 more
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