An updated overview with simple and practical approach for developing in vitro–in vivo correlation

Preclinical Research & Development

[1]  Kannan Krishnan,et al.  Physiologically-based pharmacokinetic (PBPK) models in toxicity testing and risk assessment. , 2012, Advances in experimental medicine and biology.

[2]  J. Morais,et al.  The new European Medicines Agency guideline on the investigation of bioequivalence. , 2010, Basic & clinical pharmacology & toxicology.

[3]  Andre Hermans,et al.  Development of In Vitro-In Vivo Correlation for Amorphous Solid Dispersion Immediate-Release Suvorexant Tablets and Application to Clinically Relevant Dissolution Specifications and In-Process Controls. , 2015, Journal of pharmaceutical sciences.

[4]  J. Dressman,et al.  In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs. , 2000, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[5]  R. Upton,et al.  Population In Vitro-In Vivo Correlation Model Linking Gastrointestinal Transit Time, pH, and Pharmacokinetics: Itraconazole as a Model Drug , 2016, Pharmaceutical Research.

[6]  Vinod P. Shah,et al.  Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions , 2002, Pharmaceutical Research.

[7]  J. Dressman,et al.  Simulation of fasting gastric conditions and its importance for the in vivo dissolution of lipophilic compounds. , 2005, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[8]  G. Granneman,et al.  Once-a-day extended-release dosage form of divalproex sodium III: development and validation of a Level A in vitro-in vivo correlation (IVIVC). , 2005, Journal of pharmaceutical sciences.

[9]  L. Augsburger,et al.  Development and validation of a non‐linear IVIVC model for a diltiazem extended release formulation , 2002, Biopharmaceutics & drug disposition.

[10]  A. Hirschfelder.  THE UNITED STATES PHARMACOPEIAL CONVENTION , 1930 .

[11]  L. Gonçalves de Lima,et al.  Development of a level A in vitro-in vivo correlation for extended release dosage forms of quetiapine fumarate , 2015, Drug Research.

[12]  A S Hussain,et al.  Evaluation of "external" predictability of an in vitro-in vivo correlation for an extended-release formulation containing metoprolol tartrate. , 2000, Journal of pharmaceutical sciences.

[13]  N. Lordi,et al.  Some factors affecting the release of a water-soluble drug from a compressed hydrophilic matrix. , 1966, Journal of pharmaceutical sciences.

[14]  M. Bresciani,et al.  An in vitro-in vivo correlation study for nifedipine immediate release capsules administered with water, alcoholic and non-alcoholic beverages: Impact of in vitro dissolution media and hydrodynamics. , 2016, International journal of pharmaceutics.

[16]  Suneel K. Gupta,et al.  Application of in vitro-in vivo correlations (IVIVC) in setting formulation release specifications. , 2000, Biopharmaceutics & drug disposition.

[17]  Malcolm Rowland,et al.  Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective , 2018, Clinical pharmacology and therapeutics.

[18]  Jaber Emami,et al.  In vitro - in vivo correlation: from theory to applications. , 2006, Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques.

[19]  N. Peppas,et al.  Mechanisms of solute release from porous hydrophilic polymers , 1983 .

[20]  Vinod P. Shah,et al.  In Vitro Dissolution Profile of Water-Insoluble Drug Dosage Forms in the Presence of Surfactants , 1989, Pharmaceutical Research.

[21]  Michael Levin.  Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System , 2001 .

[22]  J. Crison,et al.  A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability , 1995, Pharmaceutical Research.

[23]  S. Giovagnoli,et al.  IVIVC from Long Acting Olanzapine Microspheres , 2014, International journal of biomaterials.

[24]  J. Dressman,et al.  Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract. , 1997, Advanced drug delivery reviews.

[25]  I. Wilding.  Evolution of the biopharmaceutics classification system (BCS) to oral modified release (MR) formulations; what do we need to consider? , 1999, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[26]  A. Dunne,et al.  In Vivo–In Vitro Correlation (IVIVC) Modeling Incorporating a Convolution Step , 2001, Journal of Pharmacokinetics and Pharmacodynamics.

[27]  J. W. Moore,et al.  Mathematical comparison of dissolution profiles , 1996 .

[28]  Sarfaraz K. Niazi.  Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System , 2004, Handbook of Pharmaceutical Manufacturing Formulations, Third Edition.

[29]  T. Higuchi.  MECHANISM OF SUSTAINED-ACTION MEDICATION. THEORETICAL ANALYSIS OF RATE OF RELEASE OF SOLID DRUGS DISPERSED IN SOLID MATRICES. , 1963, Journal of pharmaceutical sciences.

[30]  Hao-Hsin Yu,et al.  Development of an Extended-Release Formulation for Apremilast and a Level A in Vitro-in Vivo Correlation Study in Beagle Dogs. , 2016, Chemical & pharmaceutical bulletin.

[31]  Adrian Dunne.  Approaches to Developing In Vitro–In Vivo Correlation Models , 2007 .

[32]  Michael Levin,et al.  Extended Release Oral Dosage Forms‚ÄîDevelopment,Evaluation, and Application of In Vitro/In Vivo Correlations , 2001 .

[33]  N. Peppas,et al.  Modeling of drug release from swellable polymers. , 2000, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

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

[35]  J. Devane.  Oral drug delivery technology : Addressing the solubility/permeability paradigm , 1998 .

[36]  Soyoung Shin,et al.  Development of a Physiologically Relevant Population Pharmacokinetic in Vitro-in Vivo Correlation Approach for Designing Extended-Release Oral Dosage Formulation. , 2017, Molecular pharmaceutics.

[37]  C. Gaynor,et al.  International Biometric Society A DIFFERENTIAL EQUATIONS APPROACH TO IN VITRO – IN VIVO CORRELATION MODELLING , 2008 .

[38]  Panos Macheras,et al.  A century of dissolution research: from Noyes and Whitney to the biopharmaceutics classification system. , 2006, International journal of pharmaceutics.

[39]  Talia Flanagan,et al.  Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms , 2017, The AAPS Journal.

[40]  G L Amidon,et al.  The influence of the interdigestive migrating myoelectric complex on the gastric emptying of liquids. , 1990, Gastroenterology.

[41]  Panos Macheras,et al.  Quantitative Biopharmaceutics Classification System: The Central Role of Dose/Solubility Ratio , 2003, Pharmaceutical Research.

[42]  Michael Levin,et al.  Supac-Mr: Modified Release Solid Oral Dosage Forms‚ÄîScale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation , 2001 .

[43]  Masoud Jamei,et al.  Recent Advances in Development and Application of Physiologically-Based Pharmacokinetic (PBPK) Models: a Transition from Academic Curiosity to Regulatory Acceptance , 2016, Current Pharmacology Reports.

[44]  J. Abraham.  The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use , 2009 .

[45]  Amitava Mitra,et al.  Use of In Vitro-In Vivo Correlation (IVIVC) to facilitate the development of polymer-based controlled release injectable formulation. , 2010, Recent patents on drug delivery & formulation.

[46]  S. Jacob,et al.  Preparation and evaluation of fast-disintegrating effervescent tablets of glibenclamide. , 2009, Drug development and industrial pharmacy.

[47]  Cynthia K. Brown,et al.  FIP Guidelines for Dissolution Testing of Solid Oral Products. , 2018, Journal of pharmaceutical sciences.

[48]  Anroop B Nair,et al.  Loratidine buccal films for allergic rhinitis: development and evaluation , 2014, Drug development and industrial pharmacy.

[49]  A. W. Hixson,et al.  Dependence of Reaction Velocity upon surface and Agitation , 1931 .

[50]  F. Lagrange.  Developing solid oral dosage forms: pharmaceutical theory and practice, Y. Qiu, Y. Chen, G.G.Z. Zhang, L. Liu, W. Porter. Elsevier (2009). 978 pp., 155 €, ISBN: 978-0-444-53242-8 , 2010 .

[51]  S. Qureshi.  In Vitro-In Vivo Correlation (IVIVC) and Determining Drug Concentrations in Blood from Dissolution Testing - A Simple and Practical Approach , 2010 .

[52]  J. Crison,et al.  A survey on IVIVC/IVIVR development in the pharmaceutical industry – Past experience and current perspectives , 2017, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[53]  Anroop B Nair,et al.  Emulsion forming drug delivery system for lipophilic drugs. , 2012, Acta poloniae pharmaceutica.

[54]  Patrick Marroum,et al.  Development and Internal Validation of an In Vitro-in Vivo Correlation for a Hydrophilic Metoprolol Tartrate Extended Release Tablet Formulation , 1998, Pharmaceutical Research.

[55]  Jessie Wilson,et al.  Concept Mapping , 2016, Qualitative health research.

[56]  Sandra Suarez-Sharp,et al.  Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications , 2016, The AAPS Journal.

[57]  John Devane,et al.  In Vitro-in Vivo Correlations , 1997, Advances in Experimental Medicine and Biology.

[58]  M. D. Hussain,et al.  In vitro Methods for In vitro-In vivo Correlation (IVIVC) for Poorly Water Soluble Drugs: Lipid Based Formulation Perspective. , 2018, Current drug delivery.

[59]  Ewart R. Carson,et al.  Mathematical modeling of dynamic biological systems , 1979 .

[60]  R. Pawar,et al.  In-vitro in-vivo correlation (IVIVC) in nanomedicine: Is protein corona the missing link? , 2017, Biotechnology advances.

[61]  Jack A Cook,et al.  Development strategies for IVIVC in an industrial environment , 2012, Biopharmaceutics & drug disposition.

[62]  M C Meyer,et al.  Carbamazepine level‐A in vivo–in vitro correlation (IVIVC): a scaled convolution based predictive approach , 2000, Biopharmaceutics & drug disposition.

[63]  J. Cardot,et al.  In vitro/in vivo correlations: Scientific implications and standardisation , 2011, European Journal of Drug Metabolism and Pharmacokinetics.

[64]  Margareth R. C. Marques.  Dissolution Media Simulating Fasted and Fed States , 2004 .

[65]  S. Qureshi.  In Vitro-In Vivo Correlation (IVIVC) and Determining Drug Concentrations in Blood from Dissolution Testing A Simple and Practical Approach~!2009-10-30~!2010-01-04~!2010-04-29~! , 2010 .

[66]  S. Jacob,et al.  Preparation and evaluation of niosome gel containing acyclovir for enhanced dermal deposition , 2017, Journal of liposome research.