Literature DB >> 7667204

Without extrapolation, Cmax/AUC is an effective metric in investigations of bioequivalence.

L Tothfalusi1, L Endrenyi.   

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Year:  1995        PMID: 7667204     DOI: 10.1023/a:1016237826520

Source DB:  PubMed          Journal:  Pharm Res        ISSN: 0724-8741            Impact factor:   4.200


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  11 in total

1.  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

2.  Novel direct curve comparison metrics for bioequivalence.

Authors:  J E Polli; A M McLean
Journal:  Pharm Res       Date:  2001-06       Impact factor: 4.200

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

Review 4.  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

5.  Average parameters as a trend to reduce the residual variability in bioequivalence trials.

Authors:  P Fagiolino; M Vazquez
Journal:  Eur J Drug Metab Pharmacokinet       Date:  1998 Apr-Jun       Impact factor: 2.441

6.  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

7.  The duration of measuring partial AUCs for the assessment of bioequivalence.

Authors:  L Endrenyi; F Csizmadia; L Tothfalusi; A H Balch; M L Chen
Journal:  Pharm Res       Date:  1998-03       Impact factor: 4.200

8.  Sensitive and specific determination of the equivalence of absorption rates.

Authors:  L Endrenyi; P Al-Shaikh
Journal:  Pharm Res       Date:  1995-12       Impact factor: 4.200

9.  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

10.  Metrics comparing simulated early concentration profiles for the determination of bioequivalence.

Authors:  L Endrenyi; F Csizmadia; L Tothfalusi; M L Chen
Journal:  Pharm Res       Date:  1998-08       Impact factor: 4.200

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