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According to the Biopharmaceutics Classification System (BCS) drug substances are classified to four classes upon their solubility and permeability: [1] Class I – high permeability, high solubility. Example: metoprolol, paracetamol [2] Those compounds are well absorbed and their absorption rate is usually higher than excretion.
The Chinese definition of "bioequivalence" entails having the test drug's geometric mean C max, AUC (0–t), and AUC (0–∞) fall into 80%–125% of the reference drug in both fasting and fed states. The reference drug should be preferably the original brand-name drug, then (if not available) an internationally-recognized generic approved by ...
In practice, the drug concentration is measured at certain discrete points in time and the trapezoidal rule is used to estimate AUC. In pharmacology, the area under the plot of plasma concentration of a drug versus time after dosage (called “area under the curve” or AUC) gives insight into the extent of exposure to a drug and its clearance ...
Multiphasic absorption: Drugs injected intravenously are removed from the plasma through two primary mechanisms: (1) Distribution to body tissues and (2) metabolism + excretion of the drugs. The resulting decrease of the drug's plasma concentration follows a biphasic pattern (see figure). Plasma drug concentration vs time after an IV dose
Whether a drug is taken with or without food will also affect absorption, other drugs taken concurrently may alter absorption and first-pass metabolism, intestinal motility alters the dissolution of the drug and may affect the degree of chemical degradation of the drug by intestinal microflora.
The drug apparent permeability (P app) is calculated by normalizing the drug flux (j) over the initial concentration of the API in the donor compartment (c 0) as: Equation 2: = / Dimensionally, the P app represents a velocity, and it is normally expressed in cm/sec. The highest is the permeability, the highest is expected to be the ...