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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 ...
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.
At the beginning of the test, the drug is added to the donor compartment, and the acceptor compartment is drug-free. After an incubation period which may include stirring, the sandwich is separated and the amount of drug is measured in each compartment. Mass balance allows calculation of drug that remains in the membrane.
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 ...
In pharmacology, bioavailability is a subcategory of absorption and is the fraction (%) of an administered drug that reaches the systemic circulation. [1]By definition, when a medication is administered intravenously, its bioavailability is 100%.
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 ...
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