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Clinical Research and Regulatory Affairs Volume 22, 2005 - Issue 1
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Research Article

Deconvolution Based Approach for Level A In Vivo-In Vitro Correlation Modelling: Statistical Considerations

Adrian Dunne Department of Statistics and Actuarial Science, University College Dublin, Belfield, Dublin 4, Ireland
,
Clare Gaynor Department of Statistics and Actuarial Science, University College Dublin, Belfield, Dublin 4, Ireland
&
John Davis Pfizer Global Research & Development, Sandwich, England
Pages 1-14 | Published online: 10 Oct 2008

Citations (18)

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Tom Jacobs, Stefaan Rossenu, Adrian Dunne, Geert Molenberghs, Roel Straetemans & Luc Bijnens. (2008) Combined Models for Data from In Vitro–In Vivo Correlation Experiments. Journal of Biopharmaceutical Statistics 18:6, pages 1197-1211.
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Articles from other publishers (17)

Preshita P. Desai & Vandana B. Patravale. 2021. Characterization of Pharmaceutical Nano and Microsystems. Characterization of Pharmaceutical Nano and Microsystems 137 170 .
Elvira M. Erhardt, Moreno Ursino, Jeike Biewenga, Tom Jacobs & Mauro Gasparini. (2018) Bayesian knowledge integration for an in vitro–in vivo correlation model . Biometrical Journal 61:5, pages 1104-1119.
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Roberto Gomeni, Lanyan (Lucy) Fang, Françoise Bressolle‐Gomeni, Thomas J. Spencer, Stephen V. Faraone & Andrew Babiskin. (2019) A General Framework for Assessing In vitro/In vivo Correlation as a Tool for Maximizing the Benefit‐Risk Ratio of a Treatment Using a Convolution‐Based Modeling Approach . CPT: Pharmacometrics & Systems Pharmacology 8:2, pages 97-106.
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Tae Hwan Kim, Soyoung Shin & Beom Soo Shin. (2017) Model-based drug development: application of modeling and simulation in drug development. Journal of Pharmaceutical Investigation 48:4, pages 431-441.
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Junshan Qiu, Marilyn Martinez & Ram Tiwari. (2016) Evaluating In Vivo-In Vitro Correlation Using a Bayesian Approach. The AAPS Journal 18:3, pages 619-634.
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Filippos Kesisoglou, Binfeng Xia & Nancy G. B. Agrawal. (2015) Comparison of Deconvolution-Based and Absorption Modeling IVIVC for Extended Release Formulations of a BCS III Drug Development Candidate. The AAPS Journal 17:6, pages 1492-1500.
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Filippos Kesisoglou, Stefaan Rossenu, Colm Farrell, Michiel Van Den Heuvel, Marita Prohn, Shaun Fitzpatrick, Pieter‐Jan De Kam & Ryan Vargo. (2014) Development of In Vitro – In Vivo Correlation for Extended‐Release Niacin After Administration of Hypromellose‐Based Matrix Formulations to Healthy Volunteers. Journal of Pharmaceutical Sciences 103:11, pages 3713-3723.
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B. Roudier, B. M. Davit, E. Beyssac & J-M. Cardot. (2014) In Vitro- In Vivo Correlation’s Dissolution Limits Setting. Pharmaceutical Research 31:9, pages 2529-2538.
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May Almukainzi, Nádia Araci Bou‐Chacra, Roderick B. Walker & Raimar Löbenberg. 2014. Therapeutic Delivery Solutions. Therapeutic Delivery Solutions 335 365 .
Maziar Kakhi, Patrick Marroum & Jason Chittenden. (2013) Analysis of level A in vitro–in vivo correlations for an extended‐release formulation with limited bioavailability . Biopharmaceutics & Drug Disposition 34:5, pages 262-277.
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J.-M. Cardot & B. M. Davit. (2012) In vitro–In Vivo Correlations: Tricks and Traps. The AAPS Journal 14:3, pages 491-499.
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Cian Costello, Stefaan Rossenu, An Vermeulen, Adriaan Cleton & Adrian Dunne. (2011) A time scaling approach to develop an in vitro–in vivo correlation (IVIVC) model using a convolution-based technique. Journal of Pharmacokinetics and Pharmacodynamics 38:5, pages 519-539.
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Clare Gaynor, Adrian Dunne, Cian Costello & John Davis. (2011) A population approach to in vitro–in vivo correlation modelling for compounds with nonlinear kinetics. Journal of Pharmacokinetics and Pharmacodynamics 38:3, pages 317-332.
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Clare Gaynor, Adrian Dunne & John Davis. (2009) The Effects of Averaging on Accuracy of IVIVC Model Predictions. Journal of Pharmaceutical Sciences 98:10, pages 3829-3838.
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Stephan Koehne-Voss & Iris Pigeot. (2009) A Point Estimator for the Time Course of Drug Release. Biometrical Journal 51:1, pages 146-158.
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S. Rossenu, C. Gaynor, A. Vermeulen, A. Cleton & A. Dunne. (2008) A nonlinear mixed effects IVIVC model for multi-release drug delivery systems. Journal of Pharmacokinetics and Pharmacodynamics 35:4, pages 423-441.
Crossref
Clare Gaynor, Adrian Dunne & John Davis. (2008) A Comparison of the Prediction Accuracy of Two IVIVC Modelling Techniques. Journal of Pharmaceutical Sciences 97:8, pages 3422-3432.
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