Adaptive-optimal design in PET occupancy studies

Clinical Pharmacology and Therapeutics

Volumn 87, Issue 5, 2010, Pages 563-571

  Zamuner, S ^a   Di Iorio, V L ^a   Nyberg, J ^b   Gunn, R N ^c,d   Cunningham, V J ^c   Gomeni, R ^a   Hooker, A C ^b  

^a GSK   (Italy)

^b UPPSALA UNIVERSITY   (Sweden)

^c HAMMERSMITH HOSPITAL   (United Kingdom)

^d UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ALGORITHM; ARTICLE; BLOOD LEVEL; CONTROLLED STUDY; DOSE RESPONSE; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; RECEPTOR OCCUPANCY; SIMULATION; SYSTEMATIC ERROR; TIME;

BINDING, COMPETITIVE; BRAIN; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MODELS, BIOLOGICAL; POSITRON-EMISSION TOMOGRAPHY; PROTEIN BINDING; RESEARCH DESIGN; TIME FACTORS;

EID: 77951499811     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2010.9     Document Type: Article

References (35)

1. Uppoor, R.S. et al. The use of imaging in the early development of neuropharmacological drugs: a survey of approved NDas. Clin. Pharmacol. Ther. 84, 69-74 (2008).
2. Lee, C.M. & Farde, L. Using positron emission tomography to facilitate CNS drug development. Trends Pharmacol. Sci. 27, 310-316 (2006).
3. Gefvert, O., Bergström, M., Långström, B., Lundberg, T., Lindström, L. & yates, R. Time course of central nervous dopamine-D2 and 5-HT2 receptor blockade and plasma drug concentrations after discontinuation of quetiapine (Seroquel) in patients with schizophrenia. Psychopharmacology (Berl.) 135, 119-126 (1998).
4. Catafau, a.M. et al. Pharmacokinetics and time-course of D(2) receptor occupancy induced by atypical antipsychotics in stabilized schizophrenic patients. J. Psychopharmacol. (Oxford) 22, 882-894 (2008).
5. Bergström, M. et al. MaO-a inhibition in brain after dosing with esuprone, moclobemide and placebo in healthy volunteers: in vivo studies with positron emission tomography. Eur. J. Clin. Pharmacol. 52, 121-128 (1997).
6. yassen, a., Olofsen, E., Dahan, a. & Danhof M. Pharmacokinetic- pharmacodynamic modeling of the antinociceptive efect of buprenorphine and fentanyl in rats: role of receptor equilibration kinetics. J. Pharmacol. Exp. Ther. 313, 1136-11499(2005).
7. Gupta, a., Gillard, M., Christophe, B., Chatelain, P., Massingham, R. & Hammarlund-Udenaes, M. Peripheral and central H1 histamine receptor occupancy by levocetirizine, a non-sedating antihistamine; a time course study in the guinea pig. Br. J. Pharmacol. 151, 1129-1136 (2007).
8. Mamo, D. et al. a PET study of dopamine D2 and serotonin 5-HT2 receptor occupancy in patients with schizophrenia treated with therapeutic doses of ziprasidone. Am. J. Psychiatry 161, 818-825 (2004).
9. Meyer, J.H. et al. Serotonin transporter occupancy of fve selective serotonin reuptake inhibitors at diferent doses: an [11C]DaSB positron emission tomography study. Am. J. Psychiatry 161, 826-835 (2004).
10. Bergström, M. et al. Human positron emission tomography studies of brain neurokinin 1 receptor occupancy by aprepitant. Biol. Psychiatry 55, 1007-1012 (2004).
11. Takano A. et al. Time course of dopamine D2 receptor occupancy by clozapine with medium and high plasma concentrations. Prog. Neuropsychopharmacol. Biol. Psychiatry. 30, 75-81(2006).
12. Tauscher, J., Jones, C., Remington, G., Zipursky, R.B. & Kapur, S. Signifcant dissociation of brain and plasma kinetics with antipsychotics. Mol. Psychiatry 7, 317-321 (2002).
13. Bench, C.J. et al. The time course of binding to striatal dopamine D2 receptors by the neuroleptic ziprasidone (CP-88,059-01) determined by positron emission tomography. Psychopharmacology (Berl). 124, 141-147 (1996).
14. Lim, K.S. et al. Modeling of brain D2 receptor occupancy-plasma concentration relationships with a novel antipsychotic, yKP1358, using serial PET scans in healthy volunteers. Clin. Pharmacol. Ther. 81, 252-258 (2007).
15. Mentré, F., Mallet, a. & Baccar, D. Optimal design in random-efects regression models. Biometrika 84, 429-442 (1997).
16. Hooker, a. & Vicini, P. Simultaneous population optimal design for pharmacokinetic-pharmacodynamic experiments. AAPS J. 7, E759-E785 (2005).
17. Dufull, S.B., Mentré, F. & aarons, L. Optimal design of a population pharmacodynamic experiment for ivabradine. Pharm. Res. 18, 83-89 (2001).
18. Retout, S., Dufull, S. & Mentré, F. Development and implementation of the population Fisher information matrix for the evaluation of population pharmacokinetic designs. Comput. Methods Programs Biomed. 65, 141-151 (2001)
19. Hooker, a.C., Foracchia, M., Dodds, M.G. & Vicini, P. an evaluation of population D-optimal designs via pharmacokinetic simulations. Ann. Biomed. Eng. 31, 98-111 (2003).
20. Zamuner, S. & Gomeni, R. Optimal design to estimate the time varying receptor occupancy relationship in a PET experiment. abstract 1099, annual Meeting of the Population approach Group in Europe, Copenhagen, Demark, 13-14 June 2007 http://www.page-meeting.org/?abstract=1099.
21. Kapur, S., VanderSpek, S.C., Brownlee, B.a. & Nobrega, J.N. antipsychotic dosing in preclinical models is often unrepresentative of the clinical condition: a suggested solution based on in vivo occupancy. J. Pharmacol. Exp. Ther. 305, 625-631 (2003).
22. Zamuner, S., Gomeni, R. & Bye, a. Estimate the time varying brain receptor occupancy in PET imaging experiments using non-linear fxed and mixed efect modeling approach. Nucl. Med. Biol. 29, 115-123 (2002).
23. Liefaard, L.C. et al. Population pharmacokinetic analysis for simultaneous determination of B (max) and K (D) in vivo by positron emission tomography. Mol. Imaging Biol. 7, 411-421 (2005)
24. Maloney, a., Karlsson, M.O. & Simonsson, U.S. Optimal adaptive design in clinical drug development: a simulation example. J. Clin. Pharmacol. 47, 1231-1243 (2007).
25. Petrone, M., Zamuner, S., Di Iorio, V., Gunn, R., Laruelle, M. & Gomeni, R. Model-based sequential human PET study design for optimal PK/RO assessment. abstract 1183, annual Meeting of the Population approach Group in Europe, Copenhagen, Demark, 13-14 June 2007 http://www.page-meeting.org/? abstract=1183
26. Mintun, M.a., Raichle, M.E., Kilbourn, M.R., Wooten, G.F. & Welch, M.J. a quantitative model for the in vivo assessment of drug binding sites with positron emission tomography. Ann. Neurol. 15, 217-227 (1984).
27. Yassen, A. et al. Mechanism-based PK/PD modeling of the respiratory depressant efect of buprenorphine and fentanyl in healthy volunteers. Clin. Pharmacol. Ther. 81, 50-58 (2007).
28. Dansirikul, C., Silber, H.E. & Karlsson, M.O. approaches to handling pharmacodynamic baseline responses. J. Pharmacokinet. Pharmacodyn. 35, 269-283 (2008).
29. Dodds, M.G., Hooker, a.C. & Vicini, P. Robust population pharmacokinetic experiment design. J. Pharmacokinet. Pharmacodyn. 32, 33-64 (2005).
30. Waterhouse, T.H., Redmann, S., Dufull, S.B. & Eccleston, J.a. Optimal design for model discrimination and parameter estimation for itraconazole population pharmacokinetics in cystic fbrosis patients. J. Pharmacokinet. Pharmacodyn. 32, 521-545 (2005).
31. Fedorov, V.V. Theory of Optimal Designs. (academic Press: New york, 1972).
32. Beal, S. & Sheiner L.B. NONMEM User Guides (Nonmem Project Group, 1998).
33. Foracchia, M., Hooker, a., Vicini, P. & Ruggeri, a. POPED, a software for optimal experiment design in population kinetics. Comput. Methods Programs Biomed. 74, 29-46 (2004).
34. Nyberg, J., Karlsson, M.O. & Hooker, a.C. Simultaneous optimal experimental design on dose and sample times. J. Pharmacokinet. Pharmacodyn. 36, 125-145 (2009).
35. Walther, B.A. & Moore, J.L. The concepts of bias, precision and accuracy, and their use in testing the performance of species richness estimators, with a literature review of estimator performance. Ecography 28, 815-829 (2005).