Literature DB >> 1748540

Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence.

L Endrenyi1, S Fritsch, W Yan.   

Abstract

In bioequivalence studies, the maximum concentration (Cmax) is shown to reflect not only the rate but also the extent of absorption. Cmax is highly correlated with the area under the curve (AUC) contrasting blood concentration with time. Therefore, use of the Cmax/AUC ratio is recommended for assessing the equivalence of absorption rates. The ratio is independent of both intrasubject variations and possible differences in the extent of absorption and reflects only the contrast between the absorption and disposition rate constants (ka/k).

Mesh:

Year:  1991        PMID: 1748540

Source DB:  PubMed          Journal:  Int J Clin Pharmacol Ther Toxicol        ISSN: 0174-4879


  41 in total

1.  Bioavailability of aciclovir after oral administration of aciclovir and its prodrug valaciclovir to patients with leukopenia after chemotherapy.

Authors:  H Steingrimsdottir; A Gruber; C Palm; G Grimfors; M Kalin; S Eksborg
Journal:  Antimicrob Agents Chemother       Date:  2000-01       Impact factor: 5.191

2.  Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? FDA Biopharmaceutics Coordinating Committee.

Authors:  R L Williams; W Adams; M L Chen; D Hare; A Hussain; L Lesko; R Patnaik; V Shah
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2000 Jan-Mar       Impact factor: 2.441

Review 3.  Measures of exposure versus measures of rate and extent of absorption.

Authors:  M L Chen; L Lesko; R L Williams
Journal:  Clin Pharmacokinet       Date:  2001       Impact factor: 6.447

4.  Urinary excretion: does it accurately reflect relative differences in bioavailability/systemic exposure when renal clearance is nonlinear?

Authors:  Gary A Thompson; Roger D Toothaker
Journal:  Pharm Res       Date:  2004-05       Impact factor: 4.200

Review 5.  Controversies in bioequivalence studies.

Authors:  V W Steinijans; D Hauschke; J H Jonkman
Journal:  Clin Pharmacokinet       Date:  1992-04       Impact factor: 6.447

6.  An in vitro methodology for forecasting luminal concentrations and precipitation of highly permeable lipophilic weak bases in the fasted upper small intestine.

Authors:  Dimitrios Psachoulias; Maria Vertzoni; James Butler; David Busby; Moira Symillides; Jennifer Dressman; Christos Reppas
Journal:  Pharm Res       Date:  2012-08-14       Impact factor: 4.200

Review 7.  Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence.

Authors:  Laszlo Tothfalusi; Laszlo Endrenyi; Alfredo Garcia Arieta
Journal:  Clin Pharmacokinet       Date:  2009       Impact factor: 6.447

Review 8.  Bioequivalence assessment of generic drugs: an American point of view.

Authors:  R Patnaik; L J Lesko; K Chan; R L Williams
Journal:  Eur J Drug Metab Pharmacokinet       Date:  1996 Apr-Jun       Impact factor: 2.441

9.  Absorption rate vs. exposure: which is more useful for bioequivalence testing?

Authors:  T N Tozer; F Y Bois; W W Hauck; M L Chen; R L Williams
Journal:  Pharm Res       Date:  1996-03       Impact factor: 4.200

10.  Exposure-response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tablets.

Authors:  Laszlo Tothfalusi; Szilvia Speidl; Laszlo Endrenyi
Journal:  Br J Clin Pharmacol       Date:  2007-08-15       Impact factor: 4.335

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