Literature DB >> 18405847

PK/PD modelling and simulations: utility in drug development.

Iris Rajman1.   

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.

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Year:  2008        PMID: 18405847     DOI: 10.1016/j.drudis.2008.01.003

Source DB:  PubMed          Journal:  Drug Discov Today        ISSN: 1359-6446            Impact factor:   7.851


  26 in total

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3.  Mechanism-based pharmacokinetic-pharmacodynamic modeling of bidirectional effect of danshensu on plasma homocysteine in rats.

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Journal:  Pharmacol Rev       Date:  2013-12-31       Impact factor: 25.468

5.  Structural models describing placebo treatment effects in schizophrenia and other neuropsychiatric disorders.

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7.  Deficiencies in the reporting of VD and t(1/2) in the FDA approved chemotherapy drug inserts.

Authors:  Malcolm J D'Souza; Ghada J Alabed
Journal:  Pharm Rev       Date:  2010-02-03

8.  Prediction of a potentially effective dose in humans for BAY 60-5521, a potent inhibitor of cholesteryl ester transfer protein (CETP) by allometric species scaling and combined pharmacodynamic and physiologically-based pharmacokinetic modelling.

Authors:  Olaf Weber; Stefan Willmann; Hilmar Bischoff; Volkhart Li; Alexandros Vakalopoulos; Klemens Lustig; Frank-Thorsten Hafner; Roland Heinig; Carsten Schmeck; Klaus Buehner
Journal:  Br J Clin Pharmacol       Date:  2012-02       Impact factor: 4.335

Review 9.  Pharmacokinetic-pharmacodynamic models that incorporate drug-target binding kinetics.

Authors:  Fereidoon Daryaee; Peter J Tonge
Journal:  Curr Opin Chem Biol       Date:  2019-04-28       Impact factor: 8.822

10.  Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation.

Authors:  S F Marshall; R Burghaus; V Cosson; S Y A Cheung; M Chenel; O DellaPasqua; N Frey; B Hamrén; L Harnisch; F Ivanow; T Kerbusch; J Lippert; P A Milligan; S Rohou; A Staab; J L Steimer; C Tornøe; S A G Visser
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2016-03-14
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