IMI – Oral biopharmaceutics tools project – Evaluation of bottom‐up PBPK prediction success part 2: An introduction to the simulation exercise and overview of results

Amitava Mitra | Jian Lin | Mai Anh Nguyen | Tycho Heimbach | Xavier Pepin | Leon Aarons | Maria Hammarberg | Hans Lennernäs | Alison Margolskee | Bertil Abrahamsson | Jan Bevernage | Michael B Bolger | Eva Karlsson | Mark McAllister | Adam S Darwich | Mohammed Yasin | Aleksandra Galetin | Manthena Varma | Viera Lukacova | Amin Rostami-Hodjegan | Johanna Laru | Jennifer Dressman | Edmund Kostewicz | Christer Tannergren | Shriram M Pathak | Chester Costales | Sweta Modi | Helena Thörn | Peter Langguth | Loic Laplanche | L. Aarons | A. Galetin | H. Lennernäs | V. Lukacova | J. Dressman | M. Bolger | B. Abrahamsson | O. Nicolas | T. Heimbach | A. Darwich | M. Varma | A. Rostami-Hodjegan | Helena Thörn | M. Yasin | P. Langguth | A. Mitra | E. Kostewicz | J. Biewenga | Chester Costales | Sara Carlert | X. Pepin | Jan Bevernage | M. McAllister | Charles J. Rotter | Handan He | Sara Carlert | Florent Mazuir | Charles Rotter | J. Malkki | Sergej Ramusovic | Jian Lin | Simone Hansmann | Alison Margolskee | Maria Hammarberg | C. Hilgendorf | P. Johansson | Eva M. Karlsson | Dónal Murphy | C. Tannergren | Florent Mazuir | Christine R. Xu | S. Pathak | T. Korjamo | J. Laru | Sari Pappinen | Johanna Tuunainen | Han-Dan He | Fan Wu | C. Hoft | Yan Pang | E. Huehn | James M Mullin | K. Szeto | Sweta Modi | Mei Wong | A. van Peer | R. Lloyd | C. Shardlow | Irina Mishenzon | M. Nguyen | Jonathan Brown | Loic Laplanche | Constanze Hilgendorf | Pernilla Johansson | Dónal Murphy | Olivier Nicolas | Sergej Ramusovic | Christine Xu | Timo Korjamo | Jussi Malkki | Sari Pappinen | Johanna Tuunainen | Simone Hansmann | Fan Wu | Carolin Hoft | Yan Pang | Eva Huehn | Ke X Szeto | Mei Wong | Jeike Biewenga | Achiel Van Peer | Richard Lloyd | Carole Shardlow | Irina Mishenzon | Jonathan Brown | Adam S. Darwich | James M. Mullin | Handan He | F. Mazuir | S. Ramusovic | Johanna Laru | Richard S. Lloyd | Pernilla Johansson

[1]  Amitava Mitra,et al.  IMI – Oral biopharmaceutics tools project – Evaluation of bottom‐up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes , 2017, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[2]  Xavier Pepin,et al.  IMI – oral biopharmaceutics tools project – evaluation of bottom‐up PBPK prediction success part 1: Characterisation of the OrBiTo database of compounds , 2017, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[3]  Anna Eidelman,et al.  Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets. , 2016, Molecular pharmaceutics.

[4]  Filippos Kesisoglou,et al.  Comparison of Deconvolution-Based and Absorption Modeling IVIVC for Extended Release Formulations of a BCS III Drug Development Candidate , 2015, The AAPS Journal.

[5]  Diansong Zhou,et al.  Development of physiologically based pharmacokinetic model to evaluate the relative systemic exposure to quetiapine after administration of IR and XR formulations to adults, children and adolescents , 2014, Biopharmaceutics & drug disposition.

[6]  Fabien Boulineau,et al.  In vitro-in vivo correlation strategy applied to an immediate-release solid oral dosage form with a biopharmaceutical classification system IV compound case study. , 2014, Journal of pharmaceutical sciences.

[7]  Martin Bergstrand,et al.  PBPK models for the prediction of in vivo performance of oral dosage forms. , 2014, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[8]  H Lennernäs,et al.  Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo. , 2014, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[9]  G. K. Raju,et al.  Understanding Pharmaceutical Quality by Design , 2014, The AAPS Journal.

[10]  J. Holst,et al.  Defining the Role of GLP-1 in the Enteroinsulinar Axis in Type 2 Diabetes Using DPP-4 Inhibition and GLP-1 Receptor Blockade , 2014, Diabetes.

[11]  M. H. D. de Souza,et al.  Dyspepsia and gastric emptying in end-stage renal disease patients on hemodialysis , 2013, BMC Nephrology.

[12]  Shiew-Mei Huang,et al.  The utility of modeling and simulation in drug development and regulatory review. , 2013, Journal of pharmaceutical sciences.

[13]  B. Ploeger,et al.  The virtue of translational PKPD modeling in drug discovery: selecting the right clinical candidate while sparing animal lives. , 2013, Drug discovery today.

[14]  Erik Sjögren,et al.  In silico predictions of gastrointestinal drug absorption in pharmaceutical product development: application of the mechanistic absorption model GI-Sim. , 2013, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[15]  A. Shafat,et al.  Molecular weight of barley β-glucan influences energy expenditure, gastric emptying and glycaemic response in human subjects , 2013, British Journal of Nutrition.

[16]  Yuan Chen,et al.  Application of IVIVE and PBPK modeling in prospective prediction of clinical pharmacokinetics: strategy and approach during the drug discovery phase with four case studies , 2012, Biopharmaceutics & drug disposition.

[17]  F. Kesisoglou,et al.  Using absorption simulation and gastric pH modulated dog model for formulation development to overcome achlorhydria effect. , 2011, Molecular pharmaceutics.

[18]  Thierry Lavé,et al.  PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 1: goals, properties of the PhRMA dataset, and comparison with literature datasets. , 2011, Journal of pharmaceutical sciences.

[19]  Malcolm Rowland,et al.  PHRMA CPCDC initiative on predictive models of human pharmacokinetics, part 5: prediction of plasma concentration-time profiles in human by using the physiologically-based pharmacokinetic modeling approach. , 2011, Journal of pharmaceutical sciences.

[20]  Malcolm Rowland,et al.  PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 3: comparative assessement of prediction methods of human clearance. , 2011, Journal of pharmaceutical sciences.

[21]  Vikash K. Sinha,et al.  Prediction of Human Oral Plasma Concentration-Time Profiles Using Preclinical Data , 2011, Clinical pharmacokinetics.

[22]  Hannah M Jones,et al.  Simulation of Human Intravenous and Oral Pharmacokinetics of 21 Diverse Compounds Using Physiologically Based Pharmacokinetic Modelling , 2011, Clinical pharmacokinetics.

[23]  Stefan Willmann,et al.  Mechanism-based prediction of particle size-dependent dissolution and absorption: cilostazol pharmacokinetics in dogs. , 2010, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[24]  Hannah M. Jones,et al.  Modelling and PBPK Simulation in Drug Discovery , 2009, The AAPS Journal.

[25]  L. A. Fenu,et al.  Prediction of Human Pharmacokinetics Using Physiologically Based Modeling: A Retrospective Analysis of 26 Clinically Tested Drugs , 2007, Drug Metabolism and Disposition.

[26]  J Brian Houston,et al.  BINDING OF DRUGS TO HEPATIC MICROSOMES: COMMENT AND ASSESSMENT OF CURRENT PREDICTION METHODOLOGY WITH RECOMMENDATION FOR IMPROVEMENT , 2006, Drug Metabolism and Disposition.

[27]  M. Rowland,et al.  Physiologically based pharmacokinetic modeling 1: predicting the tissue distribution of moderate-to-strong bases. , 2005, Journal of pharmaceutical sciences.

[28]  B. Messier.  Renewal of the colonic epithelium of the rat , 1960, The American Journal of Digestive Diseases.

[29]  H. Lennernäs,et al.  St John's Wort Decreases the Bioavailability of R‐ and S‐verapamil Through Induction of the First‐pass Metabolism , 2004, Clinical pharmacology and therapeutics.

[30]  G. Amidon,et al.  Human Jejunal Permeability of Two Polar Drugs: Cimetidine and Ranitidine , 2001, Pharmaceutical Research.

[31]  C. P. Leblond,et al.  Defining Epithelial Cell Progenitors in the Human Oxyntic Mucosa , 2003, Stem cells.

[32]  Anders Karlén,et al.  Hydrogen bonding descriptors in the prediction of human in vivo intestinal permeability. , 2003, Journal of molecular graphics & modelling.

[33]  Scott L Cockroft,et al.  The influence of nonspecific microsomal binding on apparent intrinsic clearance, and its prediction from physicochemical properties. , 2002, Drug metabolism and disposition: the biological fate of chemicals.

[34]  H. Kitagawa,et al.  Proliferation and cellular kinetics of villous epithelial cells and M cells in the chicken caecum , 1998, Journal of anatomy.

[35]  C. P. Leblond,et al.  Renewal of the epithelium in the descending colon of the mouse. I. Presence of three cell populations: vacuolated-columnar, mucous and argentaffin. , 1971, The American journal of anatomy.