Literature DB >> 18446522

Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds.

Marija Tubic-Grozdanis1, Michael B Bolger, Peter Langguth.   

Abstract

The goal of this study was to apply gastrointestinal simulation technology and integration of physiological parameters to predict biopharmaceutical drug classification. GastroPlus was used with experimentally determined physicochemical and pharmacokinetic drug properties to simulate the absorption of several weak acid and weak base BCS class II compounds. Simulation of oral drug absorption given physicochemical drug properties and physicochemical parameters will aid justification of biowaivers for selected BCS class II compounds.

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Year:  2008        PMID： 18446522      PMCID： PMC2751468          DOI： 10.1208/s12248-008-9023-x

Source DB:  PubMed          Journal:  AAPS J        ISSN： 1550-7416            Impact factor:   4.009


  50 in total

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3.  Comparative bioavailability of two tablet formulations of diclofenac sodium in normal subjects.

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Authors:  N S Ryder
Journal:  Clin Exp Dermatol       Date:  1989-03       Impact factor: 3.470

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Journal:  J Pharm Sci       Date:  1988-01       Impact factor: 3.534

Review 7.  Clinical pharmacokinetics of ketoprofen and its enantiomers.

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Journal:  Clin Pharmacokinet       Date:  1990-09       Impact factor: 6.447

8.  Pharmacokinetics of two oral prednisolone tablet formulations in healthy volunteers.

Authors:  G Luippold; S Schneider; M Marto; P Benöhr; B Mühlbauer
Journal:  Arzneimittelforschung       Date:  2001-11

Review 9.  Ketoprofen: a review of its pharmacologic and clinical properties.

Authors:  T G Kantor
Journal:  Pharmacotherapy       Date:  1986 May-Jun       Impact factor: 4.705

Review 10.  Clinical pharmacokinetics of terbinafine (Lamisil).

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Journal:  Clin Exp Dermatol       Date:  1989-03       Impact factor: 3.470
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  18 in total

1.  A semi-mechanistic modeling strategy to link in vitro and in vivo drug release for modified release formulations.

Authors:  Martin Bergstrand; Erik Söderlind; Ulf G Eriksson; Werner Weitschies; Mats O Karlsson
Journal:  Pharm Res       Date:  2011-09-27       Impact factor: 4.200

2.  An investigation into the importance of "very rapid dissolution" criteria for drug bioequivalence demonstration using gastrointestinal simulation technology.

Authors:  Ivan Kovacevi; Jelena Parojci; Marija Tubi-Grozdanis; Peter Langguth
Journal:  AAPS J       Date:  2009-05-20       Impact factor: 4.009

3.  Prediction of modified release pharmacokinetics and pharmacodynamics from in vitro, immediate release, and intravenous data.

Authors:  Viera Lukacova; Walter S Woltosz; Michael B Bolger
Journal:  AAPS J       Date:  2009-05-09       Impact factor: 4.009

Review 4.  Mechanistic approaches to predicting oral drug absorption.

Authors:  Weili Huang; Sau Lawrence Lee; Lawrence X Yu
Journal:  AAPS J       Date:  2009-04-21       Impact factor: 4.009

5.  Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.

Authors:  James E Polli; Bertil S I Abrahamsson; Lawrence X Yu; Gordon L Amidon; John M Baldoni; Jack A Cook; Paul Fackler; Kerry Hartauer; Gordon Johnston; Steve L Krill; Robert A Lipper; Waseem A Malick; Vinod P Shah; Duxin Sun; Helen N Winkle; Yunhui Wu; Hua Zhang
Journal:  AAPS J       Date:  2008-08-05       Impact factor: 4.009

Review 6.  Understanding the effect of API properties on bioavailability through absorption modeling.

Authors:  Filippos Kesisoglou; Yunhui Wu
Journal:  AAPS J       Date:  2008-11-06       Impact factor: 4.009

7.  In vitro-in vivo correlation of efavirenz tablets using GastroPlus®.

Authors:  Thiago da Silva Honório; Eduardo Costa Pinto; Helvécio Vinicius A Rocha; Valeria Sant'Anna Dantas Esteves; Tereza Cristina dos Santos; Helena Carla Rangel Castro; Carlos Rangel Rodrigues; Valeria Pereira de Sousa; Lucio Mendes Cabral
Journal:  AAPS PharmSciTech       Date:  2013-08-14       Impact factor: 3.246

8.  In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen.

Authors:  Yasuhiro Tsume; Peter Langguth; Alfredo Garcia-Arieta; Gordon L Amidon
Journal:  Biopharm Drug Dispos       Date:  2012-08-21       Impact factor: 1.627

9.  Application of absorption modeling to predict bioequivalence outcome of two batches of etoricoxib tablets.

Authors:  Amitava Mitra; Filippos Kesisoglou; Peter Dogterom
Journal:  AAPS PharmSciTech       Date:  2014-09-03       Impact factor: 3.246

10.  Cocrystal Solubility Product Prediction Using an in combo Model and Simulations to Improve Design of Experiments.

Authors:  Alex Avdeef
Journal:  Pharm Res       Date:  2018-02-02       Impact factor: 4.200
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