Mechanism-Based Pharmacokinetic–Pharmacodynamic Modeling—A New Classification of Biomarkers (original) (raw)
D. D. Breimer M. Danhof (1997)ArticleTitleRelevance of the application of pharmacokinetic–pharmacodynamic modelling concepts in drug development. The “Wooden Shoe” paradigm_Clin. Pharmacokinet._ 32 259–267Occurrence Handle9113436 PubMed Google Scholar
L. B. Sheiner D. R. Stanski S. Voseh R. D. Miller J. Ham (1979)ArticleTitleSimultaneous modelling of pharmacokinetics and pharmacodynamics: application to d_-tubocurarine_Clin. Pharmacol. Ther.25 358–371Occurrence Handle761446 PubMed Google Scholar
J. W. Jonker A. H. Schinkel (2004)ArticleTitlePharmacological and physiological functions of the polyspecific organic cation transporters: OTC1,2 and 3 (SLC22a1–3)J. Pharmacol. Exp. Ther.308 2–9Occurrence Handle10.1124/jpet.103.053298Occurrence Handle14576340 ArticlePubMed Google Scholar
J. P. Allen R. F. Brinkhuis L. DeemterParticleVan J. Wijnholts A. H. Schinkel (2000)ArticleTitleExtensive contribution of the multidrug transporters P-glycoprotein and Mrp1 to basal drug resistance_Cancer Res._ 60 5761–5766Occurrence Handle11059771 PubMed Google Scholar
M. R. Bouw R. Xie K. Tunblad M. Hammarlund-Udenaes (2001)ArticleTitleBlood–brain barrier transport and brain distribution of morphine-6-glucuronide in relation to the antinociceptive effect in rats—pharmacokinetic/pharmacodynamic modelling_Br. J. Pharmacol._ 134 1796–1804Occurrence Handle10.1038/sj.bjp.0704406Occurrence Handle11739257 ArticlePubMed Google Scholar
J. W. Black P. Leff (1983)ArticleTitleOperational models of pharmacological agonism_Proc. R. Soc. London, Ser. B_ 220 141–162 Google Scholar
P. H. GraafParticleVan der M. Danhof (1997)ArticleTitleAnalysis of drug–receptor interactions in vivo: a new approach in pharmacokinetic–pharmacodynamic modelling_Int. J. Clin. Pharmacol. Ther._ 35 442–446Occurrence Handle9352393 PubMed Google Scholar
P. H. GraafParticleVan der E. A. SchaickParticleVan R. A. A. Mathôt A. P. Ijzerman M. Danhof (1997)ArticleTitleMechanism-based pharmacokineticpharmacodynamic modelling of the effects of N_6-cyclopentyladenosine analogues on heart rate in rat: estimation of in vivo operational affinity and efficacy at adenosine A1 receptors_J. Pharmacol. Exp. Ther.283 809–816Occurrence Handle9353402 PubMed Google Scholar
E. H. Cox T. Kerbusch P. H. GraafParticleVan der M. Danhof (1998)ArticleTitlePharmacokinetic–pharmacodynamic modeling of the electroencephalogram effect of synthetic opioids in the rat: correlation with the interaction at the μ-opioid receptor_J. Pharmacol. Exp. Ther._ 284 1095–1103Occurrence Handle9495871 PubMed Google Scholar
K. P. Zuideveld P. H. GraafParticleVan der D. Newgreen R. Thurlow N. Petty P. Jordan L. A. Peletier M. Danhof (2004)ArticleTitleMechanism-based pharmacokinetic–pharmacodynamic modelling of 5-HT1A receptor agonists: estimation of in vivo affinity and intrinsic efficacy_J. Pharmacol. Exp. Ther._ 308 1012–1020Occurrence Handle10.1124/jpet.103.059030Occurrence Handle14718609 ArticlePubMed Google Scholar
S. A. G. Visser F. L. C. Wolters J. M. Gubbens-Stibbe E. Tukker P. H. GraafParticleVan der L. A. Peletier M. Danhof (2003)ArticleTitleMechanism-based PK/PD modelling of the EEG effects of GABAA receptor modulators: in vitro/in vivo correlations_J. Pharmacol. Exp. Ther._ 304 88–201Occurrence Handle10.1124/jpet.102.042341Occurrence Handle12490579 ArticlePubMed Google Scholar
P. H. GraafParticleVan der E. A. SchaickParticleVan S. A. G. Visser H. J. M. M. GreefParticleDe A. P. Ijzerman M. Danhof (1999)ArticleTitleMechanism-based pharmacokinetic–pharmacodynamic modelling of antilipolytic effects of adenosine A1 receptor agonists in rats: prediction of tissue-dependent efficacy in vivoJ. Pharmacol. Exp. Ther.290 702–709Occurrence Handle10411581 PubMed Google Scholar
E. H. Cox M. W. E. Langemeijer J. M. Gubbens-Stibbe K. T. Muir M. Danhof (1999)ArticleTitleThe comparative pharmacodynamics of remifentanil and its metabolite GR90291 in a rat electroencephalographic model_Anesthesiology_ 90 535–544Occurrence Handle10.1097/00000542-199902000-00030Occurrence Handle9952162 ArticlePubMed Google Scholar
M. Garrido J. M. Gubbens-Stibbe H. J. Tukker E. H. Cox J. Freitag Drabbe KünzelParticlevon A. P. Ijzerman M. Danhof P. H. GraafParticleVan der (2000)ArticleTitlePharmacokinetic–pharmacodynamic analysis of the EEG effect of alfentanil in rats following β-funaltrexamine-induced μ-opioid receptor knockdown in vivoPharm. Res.17 653–659Occurrence Handle10.1023/A:1007513812018Occurrence Handle10955836 ArticlePubMed Google Scholar
N. L. Dayneka V. Garg W. J. Jusko (1993)ArticleTitleComparison of four basic models of indirect pharmacodynamic responses_J. Pharmacokinet. Biopharm._ 21 457–478Occurrence Handle10.1007/BF01061691Occurrence Handle8133465 ArticlePubMed Google Scholar
D. E. Mager E. Wyska W. J. Jusko (2003)ArticleTitleDiversity of mechanism-based pharmacodynamic models_Drug Metab. Dispos._ 31 510–519Occurrence Handle10.1124/dmd.31.5.510Occurrence Handle12695336 ArticlePubMed Google Scholar
Y. N. Sun W. J. Jusko (1998)ArticleTitleTransit compartments versus gamma distribution function to model signal transduction processes in pharmacodynamics_J. Pharm. Sci._ 87 732–737Occurrence Handle10.1021/js970414zOccurrence Handle9607951 ArticlePubMed Google Scholar
R. Ramakrishnan D. C. DuBois R. R. Almon N. A. Pyszczynski W. J. Jusko (2002)ArticleTitleFifth generation model for corticosteroid pharmacodynamics: application to steady-state receptor down regulation and enzyme induction patterns during seven day continuous infusion of methylprednisolone in rats_J. Pharmacokinet. Pharmacodyn._ 29 1–24Occurrence Handle10.1023/A:1015765201129Occurrence Handle12194533 ArticlePubMed Google Scholar
M. Sandström H. Lindman P. Nygren E. Lidbrink J. Bergh M. O. Karlsson (2005)ArticleTitleModel describing the relationship between pharmacokinetics and hematologic toxicity of the epirubicin–docetaxel regimen in breast cancer patients_J. Clin. Oncol._ 23 413–421Occurrence Handle10.1200/JCO.2005.09.161Occurrence Handle15585753 ArticlePubMed Google Scholar
M. Wakelkamp G. Alvan J. Gabrielsson G. Paintaud (1996)ArticleTitlePharmacodynamic modelling of furosemide tolerance after multiple intravenous administration_Clin. Pharmacol. Ther._ 60 75–88Occurrence Handle10.1016/S0009-9236(96)90170-8Occurrence Handle8689815 ArticlePubMed Google Scholar
M. Movin-Osswald M. Hammarlund-Udenaes (1995)ArticleTitleProlactin release after remoxipride by an integrated pharmacokinetic model with intra- and interindividual aspects_J. Pharmacol. Exp. Ther._ 274 921–927Occurrence Handle7636755 PubMed Google Scholar
E. B. Eckblad V. Licko (1984)ArticleTitleA model eliciting transient responses_Am. J. Physiol._ 264 R114–R121 Google Scholar
J. A. Bauer J. P. Balthasar H. L. Fung (1997)ArticleTitleApplication of pharmacodynamic modelling for designing time variant dosing regimens to overcome nitroglycerin tolerance in experimental heart failure_Pharm. Res._ 14 114–145 Google Scholar
A. Äbelö U. G. Eriksson M. O. Karlsson H. Larsson J. Gabrielsson (2000)ArticleTitleA turnover model of irreversible inhibition of gastric acid secretion by omeparzole in the dog_J. Pharmacol. Exp. Ther._ 295 662–669Occurrence Handle11046103 PubMed Google Scholar
J. W. Mandema D. R. Wada (1995)ArticleTitlePharmacodynamic model for acute tolerance development to the electroencephalographic effects of alfentanil in the rat_J. Pharmacol. Exp. Ther._ 279 1035–1042 Google Scholar
P. Veng Pedersen N. B. Modi (1993)ArticleTitleA system approach to pharmacodynamics. Input-effect control system analysis of the central nervous system effect of alfentanil_J. Pharm. Sci._ 82 266–272Occurrence Handle8450420 PubMed Google Scholar
C. H. Kleinbloesem P. BrummelenParticleVan J. HartenParticleVan M. Danhof D. D. Breimer (1987)ArticleTitleRate of increase in plasma concentration as a major determinant of its haemodynamic effects in humans_Clin. Pharmacol. Ther._ 41 26–30Occurrence Handle3802702 PubMed Google Scholar
P. Francheteau J. L. Steimer H. Merdjan M. Guerret C. Dubray (1993)ArticleTitleA mathematical model for dynamics of cardiovascular drug action: application to intravenous dihydropyridines in healthy volunteers_J. Pharmacokinet. Biopharm._ 21 489–514Occurrence Handle10.1007/BF01059111Occurrence Handle8145128 ArticlePubMed Google Scholar
K. P. Zuideveld H. J. Maas N. Treijtel P. H. GraafParticleVan der L. A. Peletier M. Danhof (2001)ArticleTitleA set-point model with oscillatory behaviour predicts the time course of (8-)-OH-DPAT induced hypothermia_Am. J. Physiol._ 281 R2059–R2071 Google Scholar
P. L. Chan N. H. G. Holford (2001)ArticleTitleDrug treatment effects on disease progression_Annu. Rev. Pharmacol. Toxicol._ 41 625–659Occurrence Handle10.1146/annurev.pharmtox.41.1.625Occurrence Handle11264471 ArticlePubMed Google Scholar
N. H. G. Holford K. E. Peace (1992)ArticleTitleMethodologic aspects of a population pharmacodynamic model for cognitive effects in Alzheimer patients treated with tacrine_Proc. Natl. Acad. Sci. USA_ 89 IssueID23 11466–11470Occurrence Handle1454835 PubMed Google Scholar
T. M. Post, J. I. Freijer, J. de Jongh, and M. Danhof. Disease system analysis: basic disease progression models in degenerative disease. Pharm. Res.22:1038–1049 (2005). Google Scholar
InstitutionalAuthorNameBiomarker Definitions Working Group (2001)ArticleTitleBiomarkers and surrogate endpoints: preferred definitions and conceptual framework_Clin. Pharmacol. Ther._ 69 89–95 Google Scholar
W. A. Colburn (2003)ArticleTitleBiomarkers in drug discovery and development: from target identification to through drug marketing_J. Clin. Pharmacol._ 43 329–341Occurrence Handle10.1177/0091270003252480Occurrence Handle12723454 ArticlePubMed Google Scholar
L. J. Lesko A. J. Atkinson (2001)ArticleTitleUse of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation and strategies_Annu. Rev. Pharmacol. Toxicol._ 41 347–366Occurrence Handle10.1146/annurev.pharmtox.41.1.347Occurrence Handle11264461 ArticlePubMed Google Scholar
P. Rolan A. J. Atkinson L. J. Lesko (2003)ArticleTitleUse of biomarkers from drug discovery to clinical practice: report on the ninth European Federation of Pharmaceutical Sciences Conference on Optimizing Drug Development_Clin. Pharmacol. Ther._ 73 284–291Occurrence Handle10.1016/S0009-9236(02)17625-9Occurrence Handle12709718 ArticlePubMed Google Scholar
P. R. Jadhav M. U. Mehta J. V. S. Gobburu (2004)ArticleTitleHow biomarkers can improve clinical drug development_Am. Pharm. Rev._ 7 62–68 Google Scholar
C. C. Peck J. Wechsler (2002)ArticleTitleReport of a workshop on confirmatory evidence to support a single clinical trial as a basis for new drug approval_Drug Inf. J._ 36 517–534 Google Scholar
C. C. Peck D. R. Rubin L. B. Sheiner (2003)ArticleTitleHypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval_Clin. Pharmacol. Ther._ 73 481–490Occurrence Handle10.1016/S0009-9236(03)00018-3Occurrence Handle12811358 ArticlePubMed Google Scholar
P. Rolan (1997)ArticleTitleThe contribution of clinical pharmacology surrogates and models to drug development—a critical appraisal_Br. J. Clin. Pharmacol._ 44 219–225Occurrence Handle10.1046/j.1365-2125.1997.t01-1-00583.xOccurrence Handle9296315 ArticlePubMed Google Scholar
A. L. Nordstrom L. Farde F. A. Wiesel K. Forslund S. Pauli C. Halldin_et al._ (1993)ArticleTitleCentral D2-dopamine receptor occupancy in relation to antipsychotic drug effects: a double-blind PET study of schizophrenic patients_Biol. Psychiatry_ 33 227–235Occurrence Handle10.1016/0006-3223(93)90288-OOccurrence Handle8097114 ArticlePubMed Google Scholar
E. Snoeck K. Verdonck P. Jacqmin H. BelleParticlevan A. G. Dupont A. PeerParticlevan M. Danhof (1998)ArticleTitlePhysiological red blood cell kinetic model to explain the apparent discrepancy between adenosine breakdown inhibition and nucleoside transporter occupancy of draflazine_J. Pharmacol. Exp. Ther._ 286 142–149Occurrence Handle9655853 PubMed Google Scholar
J. C. Scott K. V. Ponganis D. R. Stanski (1985)ArticleTitleEEG quantification of narcotic effect: the comparative pharmacodynamics of fentanyl and alfentanil_Anesthesiology_ 62 234–241Occurrence Handle3919613 PubMed Google Scholar
J. C. Scott F. E. Cooke D. R. Stanski (1991)ArticleTitleElectroencephalographic quantification of opioid effect: the comparative pharmacodynamics of fentanyl and sufentanil_Anesthesiology_ 74 34–42Occurrence Handle1670913 PubMed Google Scholar
T. D. Egan C. F. Minto D. J. Hermann J. Barr K. T. Muir S. L. Shafer (1996)ArticleTitleRemifentanil versus alfentanil: comparative pharmacokinetics and pharmacodynamics_Anesthesiology_ 84 825–833 Google Scholar
D. R. H. Huntjens M. Danhof O. E. PasquaParticleDella (2005)ArticleTitlePharmacokinetic–pharmacodynamic correlations and biomarkers in the development of COX-2 inhibitors_Rheumatology_ 44 846–859Occurrence Handle10.1093/rheumatology/keh627Occurrence Handle15855183 ArticlePubMed Google Scholar