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Pharmacokinetic Studies for Generic Drugs
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mindyhausler
7 posts
Jun 19, 2025
7:31 PM
Generic drugs that are pharmaceutically equivalent and bioequivalent to the RLD can be considered therapeutically equivalent. Products with therapeutic equivalence can be substituted for each other without any dose adjustment or additional therapeutic monitoring.

For drugs that are absorbed into the systemic circulation and act throughout the body, bioequivalence evaluation with pharmacokinetic end points as indicators has proved to be most applicable in terms of accuracy, precision, and reproducibility. Pharmacokinetics is the study of drug interactions in the body from release to absorption. The commonly used pharmacokinetic parameters include area under the curve (AUC), concentration to peak (Cmax), time to peak (Tmax), etc. These parameters related to the degree and speed of absorption can evaluate the dynamic process of release and absorption of active ingredients into the systemic circulation. Alfa Chemistry offers comprehensive pharmacokinetic studies of generic drugs to ensure therapeutic equivalence.


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