Literature DB >> 22547350

In vitro-in vivo correlations: tricks and traps.

J-M Cardot1, B M Davit.   

Abstract

In vitro-in vivo correlation (IVIVC) is a biopharmaceutical tool recommended to be used in development of formulation. When validated, it can speed up development of formulation, be used to fix dissolution limits and also as surrogate of in vivo study. However, as do all tools, it presents limitations and traps. The aim of the present paper is to investigate five common traps which could limit either the setting or use of IVIVC (1) using mean or individual values; (2) correction of absolute bioavailability; (3) correction of lag time and time scaling; (4) flip-flop model; and (5) predictability corrections.

Mesh:

Year:  2012        PMID: 22547350      PMCID: PMC3385821          DOI: 10.1208/s12248-012-9359-0

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


  21 in total

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Authors:  R Löbenberg; G L Amidon
Journal:  Eur J Pharm Biopharm       Date:  2000-07       Impact factor: 5.571

Review 2.  A mechanistic approach to understanding the factors affecting drug absorption: a review of fundamentals.

Authors:  Marilyn N Martinez; Gordon L Amidon
Journal:  J Clin Pharmacol       Date:  2002-06       Impact factor: 3.126

3.  Per cent absorbed time plots derived from blood level and/or urinary excretion data.

Authors:  J G WAGNER; E NELSON
Journal:  J Pharm Sci       Date:  1963-06       Impact factor: 3.534

4.  A comparison of the prediction accuracy of two IVIVC modelling techniques.

Authors:  Clare Gaynor; Adrian Dunne; John Davis
Journal:  J Pharm Sci       Date:  2008-08       Impact factor: 3.534

Review 5.  In vitro-in vivo relationships for oral extended-release drug products.

Authors:  D T Mauger; V M Chinchilli
Journal:  J Biopharm Stat       Date:  1997-11       Impact factor: 1.051

6.  Dissolution assay development for in vitro-in vivo correlations. Theory and case studies.

Authors:  B R Rohrs; J W Skoug; G W Halstead
Journal:  Adv Exp Med Biol       Date:  1997       Impact factor: 2.622

Review 7.  In vitro/in vivo correlations: scientific implications and standardisation.

Authors:  J M Cardot; E Beyssac
Journal:  Eur J Drug Metab Pharmacokinet       Date:  1993 Jan-Mar       Impact factor: 2.441

Review 8.  Human intestinal permeability.

Authors:  H Lennernäs
Journal:  J Pharm Sci       Date:  1998-04       Impact factor: 3.534

9.  Neutron activation-based gamma scintigraphy in pharmacoscintigraphic evaluation of an Egalet constant-release drug delivery system.

Authors:  Janne Marvola; Hanna Kanerva; Lillian Slot; Maija Lipponen; Tommi Kekki; Heikki Hietanen; Sirpa Mykkänen; Kari Ariniemi; Kai Lindevall; Martti Marvola
Journal:  Int J Pharm       Date:  2004-08-20       Impact factor: 5.875

10.  Development of a New Type of Prolonged Release Hydrocodone Formulation Based on Egalet® ADPREM Technology Using In Vivo-In Vitro Correlation.

Authors:  Pernille H Hemmingsen; Anne-Mette Haahr; Christine Gunnergaard; Jean-Michel Cardot
Journal:  Pharmaceutics       Date:  2011-03-09       Impact factor: 6.321

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  21 in total

1.  Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalence.

Authors:  James E Polli; Jack A Cook; Barbara M Davit; Paul A Dickinson; Domenick Argenti; Nancy Barbour; Alfredo García-Arieta; Jean-Marie Geoffroy; Kerry Hartauer; Shoufeng Li; Amitava Mitra; Francis X Muller; Vivek Purohit; Manuel Sanchez-Felix; John W Skoug; Kin Tang
Journal:  AAPS J       Date:  2012-06-09       Impact factor: 4.009

Review 2.  Long-acting injectable hormonal dosage forms for contraception.

Authors:  Linfeng Wu; Dileep R Janagam; Timothy D Mandrell; James R Johnson; Tao L Lowe
Journal:  Pharm Res       Date:  2015-04-22       Impact factor: 4.200

3.  Time Scaling for In Vitro-In Vivo Correlation: the Inverse Release Function (IRF) Approach.

Authors:  Jean Michel Cardot; John C Lukas; Paula Muniz
Journal:  AAPS J       Date:  2018-08-29       Impact factor: 4.009

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.  Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications.

Authors:  Sandra Suarez-Sharp; Min Li; John Duan; Heta Shah; Paul Seo
Journal:  AAPS J       Date:  2016-08-01       Impact factor: 4.009

6.  Examining the Use of a Mechanistic Model to Generate an In Vivo/In Vitro Correlation: Journey Through a Thought Process.

Authors:  Bipin Mistry; Nikunjkumar Patel; Masoud Jamei; Amin Rostami-Hodjegan; Marilyn N Martinez
Journal:  AAPS J       Date:  2016-06-16       Impact factor: 4.009

7.  Evaluating In Vivo-In Vitro Correlation Using a Bayesian Approach.

Authors:  Junshan Qiu; Marilyn Martinez; Ram Tiwari
Journal:  AAPS J       Date:  2016-02-19       Impact factor: 4.009

8.  Effect of the Subcutaneous Environment on Phase-Sensitive In Situ-Forming Implant Drug Release, Degradation, and Microstructure.

Authors:  Luis Solorio; Agata A Exner
Journal:  J Pharm Sci       Date:  2015-10-27       Impact factor: 3.534

9.  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

10.  Transformation of Meloxicam Containing Nanosuspension into Surfactant-Free Solid Compositions to Increase the Product Stability and Drug Bioavailability for Rapid Analgesia.

Authors:  Csaba Bartos; Rita Ambrus; Gábor Katona; Tamás Sovány; Róbert Gáspár; Árpád Márki; Eszter Ducza; Anita Ivanov; Ferenc Tömösi; Tamás Janáky; Piroska Szabó-Révész
Journal:  Drug Des Devel Ther       Date:  2019-11-28       Impact factor: 4.162

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