Within-subject pharmacokinetic variability has a strong influence on individual exposure ratios in bioequivalence studies, hence on drug formulation interchangeability.
Summary: Introduction: Bioequivalence between a reference and a generic drug is based on the hypothesis that a ± 20% change in blood exposure (or ± 10% for drugs with narrow therapeutic index, NTI) following the generic/reference switch will not have any therapeutic consequences. However, the indivi...
| Published in: | European Journal of Clinical Pharmacology Vol. 79; no. 11; pp. 1565 - 1579 |
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| Main Authors: | , , , |
| Format: | equations & formulas research tables/charts Journal Article |
| Published: |
Springer Nature
Nov2023
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| Online Access: | View this record in EBSCOhost |