Literature DB >> 9383724

Individual and average bioequivalence of highly variable drugs and drug products.

K K Midha1, M J Rawson, J W Hubbard.   

Abstract

Mesh:

Year:  1997        PMID: 9383724     DOI: 10.1021/js960516+

Source DB:  PubMed          Journal:  J Pharm Sci        ISSN: 0022-3549            Impact factor:   3.534


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  7 in total

1.  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

2.  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

3.  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

Review 4.  Requirements for generic antiepileptic medicines: a clinical perspective.

Authors:  Eugen Trinka; Günter Krämer; Martin Graf
Journal:  J Neurol       Date:  2011-06-11       Impact factor: 4.849

5.  Pharmacokinetics and biodistribution of the cyclin-dependent kinase inhibitor -CR8- in mice.

Authors:  Hatem Sallam; Ibrahim El-Serafi; Laurent Meijer; Moustapha Hassan
Journal:  BMC Pharmacol Toxicol       Date:  2013-09-30       Impact factor: 2.483

6.  Trapezoid bioequivalence: A rational bioavailability evaluation approach on account of the pharmaceutical-driven balance of population average and variability.

Authors:  Sara Soufsaf; Fahima Nekka; Jun Li
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2022-03-18

7.  Development of in vitro - in vivo correlations for newly optimized Nimesulide formulations.

Authors:  Muhammad Hanif; Muhammad Harris Shoaib; Rabia Ismail Yousuf; Farya Zafar
Journal:  PLoS One       Date:  2018-08-31       Impact factor: 3.240

  7 in total

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