Results 1 to 10 of about 31,268,655 (339)
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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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
doaj +2 more sources
Pharmaceutics, 2021 The present work evaluates the food effect on the absorption of rivaroxaban (Riva), a BCS II drug, from the orally administered commercial immediate-release tablet (Xarelto IR) using physiologically based pharmacokinetic (PBPK) and conventional in vitro ...
Varun Kushwah +5 more
doaj +2 more sources
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
doaj +2 more sources
Development of a Biphasic Modified‐Release Ibuprofen Tablet Formulation: Single‐Dose and Multiple‐Dose Pharmacokinetics and Food‐Effect Studies [PDF]
Clinical and Translational ScienceIbuprofen is the most commonly used NSAID; however, its short biological half‐life, reflected in the short duration of pain relief, limits the comfortableness of its usage. This study evaluated the pharmacokinetic properties of a newly developed biphasic
Ludmila Kvapilová +6 more
doaj +2 more sources
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
doaj +2 more sources
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
doaj +2 more sources
Leveraging GPT-4 for Food Effect Summarization to Enhance Product-Specific Guidance Development via Iterative Prompting [PDF]
Journal of Biomedical Informatics, 2023 Food effect summarization from New Drug Application (NDA) is an essential component of product-specific guidance (PSG) development and assessment, which provides the basis of recommendations for fasting and fed bioequivalence studies to guide the ...
Yiwen Shi +9 more
semanticscholar +1 more source
Frontiers in Pharmacology, 2022 This study aimed to apply a physiologically based pharmacokinetic (PBPK) model to predict optimal dosing regimens of pazopanib (PAZ) for safe and effective administration when co-administered with CYP3A4 inhibitors, acid-reducing agents, food, and ...
Chunnuan Wu +16 more
doaj +1 more source
Pharmaceutics, 2023 Paliperidone was approved by the US FDA in 2006 as an extended-release (ER) tablet (Invega®) for the once-daily treatment of schizophrenia. This osmotic-controlled release oral delivery system (OROS) offers advantages, such as the prevention of plasma ...
Saima Subhani +10 more
doaj +1 more source