Bioavailability

Bioavailability - Bioavailability/Bioequivalence...

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Bioavailability/Bioequivalence
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Definitions/Concepts Pharmaceutical equivalence Contain identical active ingredients, strength, etc. Bioequivalence Comparison of bioavailability Comparison of extents and rates of absorption Differing dosage forms, differing lots of drug, generic versus brand name
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Doesn’t need to be absolutely identical From Katz et al US Pharmacist 2003
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Bioequivalence Quantitative comparison of AUC Cmax Tmax Statistics involved 90% confidence levels of ALL THREE parameters must be within -20%/+25% to be bioequivalent
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For example…. From Katz et al US Pharmacist 2003
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Bioavailability Absolute bioavailability F – fraction administered dose that reaches systemic circulation Measure? AUC (from t= zero to infinity) Total drug reaching blood directly proportional to AUC IV dosing the reference (F=1.0) (Unless you can’t give it iv!)
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Bioavailability Give drug IV measure AUC Give drug extravascularly Calculate ratio Remember Total drug absorbed α AUC F =absolute bioavail. = AUC ev /AUC iv e.g. if this ratio=0.8 then 80% bioavailable
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Relative or Comparative Bioav.
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