The absorption is limited by the permeation rate but the drug is solvated very fast.Class III - low permeability, high solubility.A correlation between the bioavailability and the solvation can be found. The of those products is limited by their solvation rate.Class II - high permeability, low solubility.Those compounds are well absorbed and their absorption rate is usually higher than excretion.BCS classes According to the Biopharmaceutical Classification System (BCS) drug substances are classified to four classes upon their solubility and permeability:.The Biopharmaceutics Classification System (BCS) is the result of continuous efforts in mathematical analysis for the elucidation of the kinetics and dynamics of the drug process in the gastrointestinal tract (GIT) for NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) filings and biowaivers. Biowaivers for BCS Class 3 drugs with Q1, Q2 restrictions. Class 1 determination and related regulatory relief, two.
Approval) and ANDAs, the drug substance has to be BCS.
0 kommentar(er)
