When the in vivo dissolution of an IR solid oral dosage form is rapid in relation to gastric emptying and the drug has high permeability, the rate and extent of drug absorption is unlikely to be dependent on drug dissolution and/or gastrointestinal transit time.
Observed in vivo differences in the rate and extent of absorption of a drug from two pharmaceutically equivalent solid oral products may be due to differences in drug dissolution in vivo.2 Instead of conducting expensive and time-consuming in vivo studies, the physicochemical properties of the API, permeability data and a dissolution test can be adopted as the surrogate basis for the decision of product approval. not considered necessary for product approval). Introduction What is a Biowaiver? A biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (i.e.
0 kommentar(er)
