Dose Linearity and Proportionality

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Abstract

A desirable characteristic of a drug is linear pharmacokinetic properties to facilitate dose and dose regimen adjustment in patients. “Linear pharmacokinetics” implies that any concentration–time profiles normalized for dose and time are superimposable (Ludden 1991). Thus, one of the necessary conditions for linear pharmacokinetics is dose proportionality, and its assessment is a fundamental pharmacokinetic analysis conducted during the clinical development of a new drug candidate.

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Eisenblaetter, T., Teichert, L., Burnette, R., & Hutson, P. (2020). Dose Linearity and Proportionality. In Drug Discovery and Evaluation: Methods in Clinical Pharmacology, Second Edition (pp. 695–714). Springer International Publishing. https://doi.org/10.1007/978-3-319-68864-0_5

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