PK/PD modelling and simulations: utility in drug development

Drug Discovery Today
Iris Rajman

Abstract

Pharmacokinetic/pharmacodynamic (PK/PD) modelling and simulation can be used as an 'applied science' tool to provide answers on efficacy and safety of new drugs faster and at a lower cost. PK/PD modelling can be used from the preclinical phase through all clinical phases of drug development. Optimal use of PK/PD modelling and simulation will lead to fewer failed compounds, fewer study failures and smaller numbers of studies needed for registration. For PK/PD modelling to fulfil its potential in drug development, it needs to be embraced across the industry and regulatory agencies, and more education on this topic is required.

References

Oct 7, 2000·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·L J LeskoB Stewart
Oct 14, 2000·European Journal of Drug Metabolism and Pharmacokinetics·R Gieschke, J L Steimer
Apr 12, 2001·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·L AaronsUNKNOWN COST B15 Experts
Jun 1, 2001·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·R GomeniA Bye
Nov 6, 2002·Journal of Biomedical Informatics·Leonard Schlessinger, David M Eddy
Sep 10, 2003·Clinical Pharmacokinetics·Wayne A Colburn, Jean W Lee
Oct 28, 2003·Diabetes Care·David M Eddy, Leonard Schlessinger
Oct 28, 2003·Diabetes Care·David M Eddy, Leonard Schlessinger
Dec 16, 2005·The AAPS Journal·Howard LeeCarl C Peck
Dec 16, 2005·The AAPS Journal·Thaddeus H GraselaCharles W Dement
May 27, 2006·Journal of Biopharmaceutical Statistics·Mark ChangAnnpey Pong
Nov 28, 2007·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Lorea BuenoIñaki F Trocóniz

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Citations

Feb 3, 2011·European Journal of Clinical Pharmacology·Francesco BellantiOscar Della Pasqua
Jan 20, 2011·European Journal of Clinical Pharmacology·Francesco Bellanti, Oscar Della Pasqua
Apr 14, 2010·Pharmaceutical Research·Zinnia P Parra-GuillénIñaki F Trocóniz
Jan 9, 2010·Briefings in Bioinformatics·Daniël B van SchalkwijkAlbert A de Graaf
Oct 4, 2011·Chemical & Pharmaceutical Bulletin·Yuko ShikamuraKakuji Tojo
Jan 14, 2012·Drug Metabolism and Pharmacokinetics·Jin Sook SongMyung Ae Bae
Jun 10, 2011·Clinical Pharmacokinetics·Venkatesh Pilla ReddyJohannes H Proost
Mar 24, 2015·Expert Opinion on Drug Metabolism & Toxicology·Mackenzie L CottrellAngela D M Kashuba
May 6, 2015·Expert Opinion on Drug Metabolism & Toxicology·Lei Diao, Bernd Meibohm
Jun 15, 2010·Expert Opinion on Drug Metabolism & Toxicology·Jong Hwan SungMichael L Shuler
Jul 12, 2011·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Kun HaoHao-Ye Li
Dec 3, 2014·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Leena-Stiina KontturiArto Urtti
Aug 1, 2015·CPT: Pharmacometrics & Systems Pharmacology·T Pene DumitrescuV D Schmith
Apr 14, 2016·CPT: Pharmacometrics & Systems Pharmacology·UNKNOWN EFPIA MID3 WorkgroupS A G Visser
Feb 22, 2012·Pharmacology & Therapeutics·Yasushi Ogawa, Masatoshi Hagiwara
Mar 3, 2009·Drug Metabolism and Pharmacokinetics·Bart A PloegerMeindert Danhof
May 6, 2015·Journal of Burn Care & Research : Official Publication of the American Burn Association·Amanda N SteeleNam K Tran
Jan 22, 2018·Journal of Pharmacokinetics and Pharmacodynamics·Marissa F DockendorfLarissa A Wenning
Aug 28, 2013·Expert Review of Clinical Pharmacology·Puja SapraJoseph Boni
Jan 2, 2014·Pharmacological Reviews·Gregory SliwoskiEdward W Lowe
Apr 19, 2017·CPT: Pharmacometrics & Systems Pharmacology·M Craig
Jun 1, 2017·American Society of Clinical Oncology Educational Book·Elena GarraldaJosep Tabernero
May 13, 2020·British Journal of Clinical Pharmacology·Geoffrey Alan WatsonAnna Spreafico

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