Literature DB >> 18780164

A nonlinear mixed effects IVIVC model for multi-release drug delivery systems.

S Rossenu1, C Gaynor, A Vermeulen, A Cleton, A Dunne.   

Abstract

The purpose of this analysis was the development of an IVIVC model, which involves a convolution step as described by O'Hara et al. and to describe a dual-release system: a controlled release formulation, which contains an initial immediate release element. Four formulations of Galantamine were used to test this modelling technique and a level A IVIVC, which meets the FDA criteria for internal and external validation, was successfully developed.

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Year:  2008        PMID： 18780164     DOI： 10.1007/s10928-008-9095-3

Source DB:  PubMed          Journal:  J Pharmacokinet Pharmacodyn        ISSN： 1567-567X            Impact factor:   2.745


  10 in total

Review 1.  Modeling and comparison of dissolution profiles.

Authors:  P Costa; J M Sousa Lobo
Journal:  Eur J Pharm Sci       Date:  2001-05       Impact factor: 4.384

2.  In vivo-in vitro correlation (IVIVC) modeling incorporating a convolution step.

Authors:  T O'Hara; S Hayes; J Davis; J Devane; T Smart; A Dunne
Journal:  J Pharmacokinet Pharmacodyn       Date:  2001-06       Impact factor: 2.745

3.  On methods of expressing dissolution rate data.

Authors:  J A Goldsmith; N Randall; S D Ross
Journal:  J Pharm Pharmacol       Date:  1978-06       Impact factor: 3.765

4.  Convolution-based approaches for in vivo-in vitro correlation modeling.

Authors:  W R Gillespie
Journal:  Adv Exp Med Biol       Date:  1997       Impact factor: 2.622

5.  Draft guidance for industry extended-release solid oral dosage forms. Development, evaluation and application of in vitro-in vivo correlations.

Authors:  H Malinowski; P Marroum; V R Uppoor; W Gillespie; H Y Ahn; P Lockwood; J Henderson; R Baweja; M Hossain; N Fleischer; L Tillman; A Hussain; V Shah; A Dorantes; R Zhu; H Sun; K Kumi; S Machado; V Tammara; T E Ong-Chen; H Mahayni; L Lesko; R Williams
Journal:  Adv Exp Med Biol       Date:  1997       Impact factor: 2.622

6.  Agonist responses of neuronal nicotinic acetylcholine receptors are potentiated by a novel class of allosterically acting ligands.

Authors:  A Schrattenholz; E F Pereira; U Roth; K H Weber; E X Albuquerque; A Maelicke
Journal:  Mol Pharmacol       Date:  1996-01       Impact factor: 4.436

7.  Linearization of dissolution rate curves by the Weibull distribution.

Authors:  F Langenbucher
Journal:  J Pharm Pharmacol       Date:  1972-12       Impact factor: 3.765

8.  Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension. The Galantamine USA-1 Study Group.

Authors:  M A Raskind; E R Peskind; T Wessel; W Yuan
Journal:  Neurology       Date:  2000-06-27       Impact factor: 9.910

9.  A 5-month, randomized, placebo-controlled trial of galantamine in AD. The Galantamine USA-10 Study Group.

Authors:  P N Tariot; P R Solomon; J C Morris; P Kershaw; S Lilienfeld; C Ding
Journal:  Neurology       Date:  2000-06-27       Impact factor: 9.910

10.  Selective inhibition of human acetylcholinesterase by galanthamine in vitro and in vivo.

Authors:  T Thomsen; H Kewitz
Journal:  Life Sci       Date:  1990       Impact factor: 5.037
  10 in total
  5 in total

1.  Population in vitro-in vivo correlation model for pramipexole slow-release oral formulations.

Authors:  Elena Soto; Sebastian Haertter; Michael Koenen-Bergmann; Alexander Staab; Iñaki F Trocóniz
Journal:  Pharm Res       Date:  2009-12-29       Impact factor: 4.200

2.  A population approach to in vitro-in vivo correlation modelling for compounds with nonlinear kinetics.

Authors:  Clare Gaynor; Adrian Dunne; Cian Costello; John Davis
Journal:  J Pharmacokinet Pharmacodyn       Date:  2011-03-16       Impact factor: 2.745

3.  A time scaling approach to develop an in vitro-in vivo correlation (IVIVC) model using a convolution-based technique.

Authors:  Cian Costello; Stefaan Rossenu; An Vermeulen; Adriaan Cleton; Adrian Dunne
Journal:  J Pharmacokinet Pharmacodyn       Date:  2011-07-07       Impact factor: 2.745

4.  In vitro- in vivo correlation's dissolution limits setting.

Authors:  B Roudier; B M Davit; E Beyssac; J-M Cardot
Journal:  Pharm Res       Date:  2014-03-28       Impact factor: 4.200

5.  Development of a Clinically Relevant Dissolution Method for Metaxalone Immediate Release Formulations Based on an IVIVC Model.

Authors:  Lucija Vuletić; M Zahirul I Khan; Drago Špoljarić; Maja Radić; Biserka Cetina-Čižmek; Jelena Filipović-Grčić
Journal:  Pharm Res       Date:  2018-06-22       Impact factor: 4.200
  5 in total

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