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Bioequivalence studies are required to be conducted using cancer patients for biosimilar drugs. Both pharmacokinetic and pharmacodynamic endpoints need to be generally investigated in biosimilar clinical trials. The test and innovative drugs are called bioequivalent if the two drugs have the same bioavailability.
A phase I trial should select pharmacodynamic markers that demonstrate the therapeutic efficacy of the drug, and should compare the pharmacodynamic effect of the test and innovative drugs in a population where the possible differences can best be observed.
Related Journals of Bioequivalence Anticancers
Bioequivalence Study Journal, MOJ Bioequivalence & Bioavailability, Journal of Bioequivalence & Bioavailability, International Journal of BioAnalytical Methods & BioEquivalence Studies, Asian journal of Pharmaceutical Care, Bioanalytical Methods & Bioequivalence Studies, Clinical & Experimental Pharmacology, Enliven: Biosimilars and Bioavailablity, Cardiovascular Pharmacology: Open Access, Chemical Speciation & Bioavailability, Pharmaceutical Regulatory Affairs: Open Access.