In Vitro-In Vivo Correlations

1. Front Matter

   Pages i-ix

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2. Examples of in Vitro-in Vivo Relationships with a Diverse Range of Quality

   • Russell J. Rackley

   Pages 1-15

3. Dissolution Assay Development for in Vitro-in Vivo Correlations

   • Brian R. Rohrs, John W. Skoug, Gordon W. Halstead

   Pages 17-30

4. in Vitro Dissolution Profile Comparison and IVIVR

   • Pradeep Sathe, Yi Tsong, Vinod P. Shah

   Pages 31-42

5. A General Framework for Non-Parametric Subject-Specific and Population Deconvolution Methods for in Vivo-in Vitro Correlation

   • Davide Verotta

   Pages 43-52

6. Convolution-Based Approaches for in Vivo-in Vitro Correlation Modeling

   • William R. Gillespie

   Pages 53-65

7. Approaches to IVIVR Modelling and Statistical Analysis

   • Adrian Dunne, Tom O’Hara, John Devane

   Pages 67-86

8. Validation of in Vitro-in Vivo Correlation Models

   • David Young, James A. Dowell, Deborah A. Piscitelli, John Devane

   Pages 87-91

9. Examples of Developing in Vitro-in Vivo Relationships

   • Jackie Butler

   Pages 93-110

10. The Biopharmaceutic Drug Classification and Drugs Administered in Extended Release (Er) Formulations

    • Owen I. Corrigan

    Pages 111-128

11. Investigating in Vitro Drug Release Mechanisms Inside Dosage Forms

    • C. D. Melia, P. Marshall, P. Stark, S. Cunningham, A. Kinahan, J. Devane

    Pages 129-135

12. Determination of Critical Manufacturing and Formulation Variables for a Hydrophilic Matrix Tablet Formulation Using an in Vitro Discriminatory Dissolution Method

    • P. Stark, A. Kinahan, S. Cunningham, J. Butler, T. O’Hara, A. Dunne et al.

    Pages 137-147

13. Artificial Neural Network Based in Vitro-in Vivo Correlations

    • Ajaz S. Hussain

    Pages 149-158

14. Setting Dissolution Specifications for Modified-Release Dosage Forms

    • Deborah A. Piscitelli, David Young

    Pages 159-166

15. Review of Methodologies for the Comparison of Dissolution Profile Data

    • Tom O’Hara, Adrian Dunne, Audrey Kinahan, Sean Cunningham, Paul Stark, John Devane

    Pages 167-171

16. Assessing Whether Controlled Release Products with Differing in Vitro Dissolution Rates Have the Same in Vivo-in Vitro Relationship

    • Guoliang Cao, Charles Locke

    Pages 173-180

17. Comparison of Methodologies for Evaluating Regional Intestinal Permeability

    • A. Raoof, D. Moriarty, D. Brayden, O. I. Corrigan, I. Cumming, J. Butler et al.

    Pages 181-189

18. in Vitro-in Vivo Relationships of Several “Immediate” Release Tablets Containing a Low Permeability Drug

    • James E. Polli

    Pages 191-198

19. Nonlinear in Vitro-in Vivo Correlations

    • Jeanne Mendell-Harary, James Dowell, Sian Bigora, Deborah Piscitelli, Jackie Butler, Colm Farrell et al.

    Pages 199-206

20. Use of Nonlinear Mixed Effects Modelling in the Development of in Vitro-in Vivo Correlations

    • Sian Bigora, Deborah Piscitelli, James Dowell, Jackie Butler, Colm Farrell, John Devane et al.

    Pages 207-215

This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep­ tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com­ pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not­ tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel­ opment of in vitro-in vivo relationships for ER products. The original idea went back ap­ proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.

• classification
• development
• drug
• drug delivery
• drugs
• microscopy
• monitoring
• organizations
• population
• relationships

• University of Maryland at Baltimore, Baltimore, USA

  David Young

• Elan Corporation, plc, Athlone, Ireland

  John G. Devane, Jackie Butler

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