Literature DB >> 7904641

Bio-International 92, conference on bioavailability, bioequivalence, and pharmacokinetic studies.

H H Blume1, K K Midha.   

Abstract

This report summarizes the discussions and statements of the Bio-International '92 conference concerning the topics highlighted at the sessions on bioequivalence of highly variable drugs (sessions I and II), importance of metabolites in assessment of bioequivalence (session II), and determination of food effects in bioequivalence studies (session IV). The objective of BIO-International '92 was to take up some key issues raised in former conferences such as BIO-international '89 in Toronto and the Drug Information Association (DIA) meeting on bioavailability/bioequivalence in Barcelona 1991. Scientists from regulatory bodies, control laboratories, academia, and industry who were interested in and experienced with the topics were invited to contribute to the open discussions regarding the state of science and technology in this field.

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Year:  1993        PMID： 7904641     DOI： 10.1002/jps.2600821125

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


  21 in total

1.  Journal impact factors: a 'bioequivalence' issue?

Authors:  A Rostami-Hodjegan; G T Tucker
Journal:  Br J Clin Pharmacol       Date:  2001-02       Impact factor: 4.335

Review 2.  Metabolites and bioequivalence: past and present.

Authors:  Andre J Jackson; Gabriel Robbie; Patrick Marroum
Journal:  Clin Pharmacokinet       Date:  2004       Impact factor: 6.447

3.  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

Review 4.  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 5.  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 6.  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 7.  Bioequivalence: issues and options.

Authors:  K K Midha; M J Rawson; J W Hubbard
Journal:  J Pharmacokinet Biopharm       Date:  1997-12

8.  Intra- and inter-subject variabilities of CGP 33101 after replicate single oral doses of two 200-mg tablets and 400-mg suspension.

Authors:  W K Cheung; F Kianifard; A Wong; J Mathieu; T Cook; V John; E Redalieu; K Chan
Journal:  Pharm Res       Date:  1995-12       Impact factor: 4.200

9.  Biopharmaceutical considerations and characterizations in development of colon targeted dosage forms for inflammatory bowel disease.

Authors:  Rajkumar Malayandi; Phani Krishna Kondamudi; P K Ruby; Deepika Aggarwal
Journal:  Drug Deliv Transl Res       Date:  2014-04       Impact factor: 4.617

10.  Pharmacokinetics of BILR 355 after multiple oral doses coadministered with a low dose of ritonavir.

Authors:  Fenglei Huang; Kristin Drda; Thomas R MacGregor; Joseph Scherer; Lois Rowland; Thuy Nguyen; Charles Ballow; Mark Castles; Patrick Robinson
Journal:  Antimicrob Agents Chemother       Date:  2008-10-27       Impact factor: 5.191
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