WebbAn accurate, sensitive and specific high performance liquid chromatographic method was developed for the determination of free phloroglucinol as well as its conjugated metabolites, that allowed as to clarify phloroglucinol pharmacokinetic behaviour in man, specially its important metabolisation, its poor systemic bioavailability after oral … WebbFrom a quality perspective, a BCS-class I based biowaiver is acceptable if the solubility of the substance is high and if very rapid or similarly rapid dissolution characteristics of the test and reference products have been demonstrated. For quality aspects of biowaiver, see the quality assessment report.
WHO “Biowaiver List”: proposal to waive in vivo bioequivalence ...
WebbPhloroglucinol derivatives are a major class of secondary metabolites. They exist widely in several families such as the Myrtaceae family, Guttiferae, Euphorbiaceae, Aspidiaceae, Compositae, Rutaceae, Rosaceae, Clusiaceae, Lauraceae, … WebbBCS classes According to the Biopharmaceutical Classification System (BCS) drug substances are classified to four classes upon their solubility and permeability: [1] Class … dynamic uncertainty
Public Assessment Report Scientific discussion Dalmevin …
WebbThe BCS is a scientific approach based on the aqueous 43 solubility and intestinal permeability characteristics of the drug substance. The BCS categorizes drug 44 substances into one of four BCS classes as follows: 45 Class I: high solubility, high permeability 46 Class II: low solubility, high permeability Webbare available, the exact BCS-class assignment can be determined by utilizing quantitative absorption/permeability data. However, since high solubility within an aqueous environment is a necessary prerequisite for an API to be eligible for a waiver from bioequivalence studies, the current focus on solubility is justified to dynamic underwear system oblivion