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Metrics evaluating bioavailability a...

Zha, Jiuhong.

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Metrics evaluating bioavailability and bioequivalence: Principles, and applications in the steady state.

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Metrics evaluating bioavailability and bioequivalence: Principles, and applications in the steady state./
Author:	Zha, Jiuhong.
Description:	234 p.
Notes:	Adviser: Laszlo Endrenyi.
Contained By:	Dissertation Abstracts International60-09B.
Subject:	Health Sciences, Pharmacology. -
Online resource:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=NQ41354
ISBN:	0612413543

Metrics evaluating bioavailability and bioequivalence: Principles, and applications in the steady state.
Zha, Jiuhong.

Metrics evaluating bioavailability and bioequivalence: Principles, and applications in the steady state. - 234 p.

Adviser: Laszlo Endrenyi.

Thesis (Ph.D.)--University of Toronto (Canada), 1999.

<italic>Bioavailability</italic> is defined by the rate and extent to which a drug substance reaches the systemic circulation. Two pharmaceutical products are considered to be <italic>bioequivalent</italic> when their bioavailabilities from the same molar dose are so similar that they are unlikely to produce clinically relevant differences in therapeutic and/or adverse effects.

ISBN: 0612413543Subjects--Topical Terms:

1017717
Health Sciences, Pharmacology.

Metrics evaluating bioavailability and bioequivalence: Principles, and applications in the steady state.
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035 $a (UnM)AAINQ41354
035 $a AAINQ41354
040 $a UnM $c UnM
100 1 $a Zha, Jiuhong. $3 1256388
245 1 0 $a Metrics evaluating bioavailability and bioequivalence: Principles, and applications in the steady state.
300 $a 234 p.
500 $a Adviser: Laszlo Endrenyi.
500 $a Source: Dissertation Abstracts International, Volume: 60-09, Section: B, page: 4550.
502 $a Thesis (Ph.D.)--University of Toronto (Canada), 1999.
520 $a <italic>Bioavailability</italic> is defined by the rate and extent to which a drug substance reaches the systemic circulation. Two pharmaceutical products are considered to be <italic>bioequivalent</italic> when their bioavailabilities from the same molar dose are so similar that they are unlikely to produce clinically relevant differences in therapeutic and/or adverse effects.
520 $a The <italic>purposes of the present study</italic> were to develop principles for evaluating quantitative properties of metrics for the determination of bioavailability and bioequivalence, to assess these properties for the maximum plasma concentration (Cmax) in single- and multiple-dose studies, and to develop and evaluate properties of secondary, steady-state metrics for assessing' the equivalence of absorption rates, clearances and volumes of distribution.
520 $a Favourable properties of metrics were defined both qualitatively and quantitatively. A good metric should be specific, show high kinetic sensitivity with respect to the underlying kinetic quantity, be linear to it, and exhibit low statistical responsiveness to variations in both observations and parameters which are not of primary interest.
520 $a The properties of metrics were illustrated on the example of Cmax by both algebraic calculations and computer simulations. It was found that the steady-state Cmax has a much lower kinetic sensitivity to the absorption rate constant (ka) than the single-dose C max, especially at high accumulation and slow absorption. The variation of Cmax is smaller at steady state than after a single dosing when the dominant source of variation is ka, Overall, Cmax should not be applied for assessing bioavailability and bioequivalence in the steady state.
520 $a Properties of various secondary metrics were evaluated for assessing the <italic>equivalence of absorption rates in the steady state</italic> by simulations. At fast absorption and low accumulation, the intercept metric has the most favourable combined kinetic and statistical features. At the unfavourable condition of slow absorption and high accumulation, AAUC is preferred. At intermediate conditions, AUCF, Swing and especially PTF are moderately favourable.
520 $a Properties of the secondary metrics were assessed also for the evaluation of the <italic>equivalence of clearances and volumes of distribution in the steady state</italic>. At high accumulation and slow absorption, Cmax , is the most favourable metric for assessing the equivalence of clearances, but least favoured for the equivalence of volumes of distribution.
590 $a School code: 0779.
650 4 $a Health Sciences, Pharmacology. $3 1017717
690 $a 0419
710 2 0 $a University of Toronto (Canada). $3 1017674
773 0 $t Dissertation Abstracts International $g 60-09B.
790 $a 0779
790 1 0 $a Endrenyi, Laszlo, $e advisor
791 $a Ph.D.
792 $a 1999
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=NQ41354