Literature DB >> 8956322

Evaluation of orally administered highly variable drugs and drug formulations.

V P Shah1, A Yacobi, W H Barr, L Z Benet, D Breimer, M R Dobrinska, L Endrenyi, W Fairweather, W Gillespie, M A Gonzalez, J Hooper, A Jackson, L J Lesko, K K Midha, P K Noonan, R Patnaik, R L Williams.   

Abstract

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Year:  1996        PMID： 8956322     DOI： 10.1023/a:1016468018478

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


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  21 in total

1.  The effect of dosing regimen on the pharmacokinetics of risedronate.

Authors:  D Y Mitchell; M A Heise; K A Pallone; M E Clay; J D Nesbitt; D A Russell; C W Melson
Journal:  Br J Clin Pharmacol       Date:  1999-10       Impact factor: 4.335

2.  Pharmacokinetics of ethionamide administered under fasting conditions or with orange juice, food, or antacids.

Authors:  B Auclair; D E Nix; R D Adam; G T James; C A Peloquin
Journal:  Antimicrob Agents Chemother       Date:  2001-03       Impact factor: 5.191

3.  Evaluation of the bioequivalence of highly-variable drugs and drug products.

Authors:  L Tothfalusi; L Endrenyi; K K Midha; M J Rawson; J W Hubbard
Journal:  Pharm Res       Date:  2001-06       Impact factor: 4.200

4.  Limits for the scaled average bioequivalence of highly variable drugs and drug products.

Authors:  Laszlo Tothfalusi; Laszlo Endrenyi
Journal:  Pharm Res       Date:  2003-03       Impact factor: 4.200

5.  Bioequivalence of highly variable drugs: a comparison of the newly proposed regulatory approaches by FDA and EMA.

Authors:  Vangelis Karalis; Mira Symillides; Panos Macheras
Journal:  Pharm Res       Date:  2011-12-28       Impact factor: 4.200

6.  Novel scaled average bioequivalence limits based on GMR and variability considerations.

Authors:  Vangelis Karalis; Mira Symillides; Panos Macheras
Journal:  Pharm Res       Date:  2004-10       Impact factor: 4.200

7.  Novel scaled bioequivalence limits with leveling-off properties.

Authors:  John Kytariolos; Vangelis Karalis; Panos Macheras; Mira Symillides
Journal:  Pharm Res       Date:  2006-10-18       Impact factor: 4.200

Review 8.  International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.

Authors:  Barbara Davit; April C Braddy; Dale P Conner; Lawrence X Yu
Journal:  AAPS J       Date:  2013-07-03       Impact factor: 4.009

Review 9.  Bioavailability and bioequivalence: focus on physiological factors and variability.

Authors:  Vangelis Karalis; Panos Macheras; Achiel Van Peer; Vinod P Shah
Journal:  Pharm Res       Date:  2008-06-13       Impact factor: 4.200

Review 10.  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
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