Application of pharmacokinetic/pharmacodynamic modelling and population approaches to drug development

International Journal of Pharmaceutical Medicine

Volumn 13, Issue 5, 1999, Pages 243-251

  Jochemsen, R ^a   Laveille, C ^a   Breimer, D D ^b  

^a IRIS Institut de Recherches Internationales Servier   (France)

^b LEIDEN UNIVERSITY   (Netherlands)

Author keywords

Drug development; Pharmacokinetic pharmacodynamic modelling; Population approaches

Indexed keywords

ARTICLE; DRUG DEVELOPMENT; MODEL; PHARMACODYNAMICS; PHARMACOKINETICS; PRIORITY JOURNAL;

EID: 0033397045     PISSN: 13649027     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (39)

1. Peck C, Barr WH, Benet LZ et al. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. Clin Pharmacol Ther 1992; 51(4):465-473.
2. Breimer DD, Danhof M. Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The 'wooden shoe' paradigm. Clin Pharmacokinet 1997; 32(4):259-267.
3. Rowland M, Tozer TN. Pharmacologic response. 1989; Book Clinical pharmacokinetics: concepts and application, 2nd edition, pp 323-346, Lea and Febiger
4. Sheiner LB, Stanski DR, Vozeh S et al. Simultaneous modelling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine. Clin Pharmacol Ther 1979; 25:358-371.
5. Jusko WJ, Ko HC. Physiologic indirect response models characterize diverse types of pharmacodynamic effects. Clin Pharmacol Ther 1994; 56:406-419.
6. Dayneka NL, Garg V, Jusko WJ. Comparison of four basic models of indirect pharmacodynamic responses. J Pharmacokinet Biopharm 1993; 21:457-478.
7. Guidance for Industry: Population pharmacokinetics. Draft guidance, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation (CDER). September 1997.
8. Aarons L, Balant LP, Mentre F, Morselli PL, Rowland M, Steimer JL, Vozeh S. Report on an expert meeting to discuss population pharmacokinetic/pharmacodynamic software. Eur J Clin Pharmacol 1994; 46:389-391.
9. Aarons L. Sparse data analysis. Eur J Drug Metab Pharmacokinet 1993; 18:97-100.
10. Aarons L, Balant LP, Mentre F, Morselli PL, Rowland M, Steimer JL, Vozeh S. Practical experience and issues in designing and performing population pharmacokinetic/pharmacodynamic studies. Eur J Clin Pharmacol 1996; 49:251-254.
11. Ludden TM. Population pharmacokinetics. J Clin Pharmacol 1988; 28;1059-1063.
12. Sheiner LB, Grasela TH. An introduction to mixed effect modelling: concepts, definitions and justification. J Pharmacokinet Biopharm 1991; suppl.:S11-S23.
13. Sheiner LB, Ludden TM. Population pharmacokinetics/pharmacodynamics. Annu Rev Pharmacol Toxicol 1992; 32:185-209.
14. Burtin P, Mentre F, Van Bree J, Steimer JL. Sparse sampling for assessment of drug exposure in toxicological studies. Eur J Drug Metab Pharmacokinet 1996; 21:105-111.
15. Ette EI, Kelman AW, Howie CA, Whiting B. An application of the population approach to animal pharmacokinetics drug drug development. Clin Res Regul Affairs 1994; 11:243-255.
16. Jackson KA, Rosenbaum SE. The application of population pharmacokinetics to the drug development process. Drug Dev and Indust Pharm 1998; 24:1155-1162.
17. McLachlan AJ. Sparse drug concentration data analysis using a population approach: a valuable tool in clinical pharmacology. Clin Exp Pharmacol Physiol 1996; 23:995-999.
18. Minto C, Schnider T. Expanding clinical applications of population pharmacodynamic modelling. Br J Clin Pharmacol 1998; 46:321-333.
19. Vozeh S, Steimer JL, Rowland M, et al. The use of population pharmacokinetics in drug development. Clin Pharmacokinet 1996; 30:81-93.
20. Atkinson AJ. The value of biomarkers and surrogate endpoints early drug development. 1998 Abstract. 5th Eufeps conference, Wiesbaden, Germany, December 7-9.
21. Boissel JP, Collet JP, Moleur P, Haugh M. Surrogate endpoints: a basis for a rational approach. Eur J Clin Pharmacol 1992; 43:235-244.
22. Colburn WA. Selecting and validating biologic markers for drug development. J Clin Pharmacol 1997; 37:355-362.
23. Collins JM, Grieshaber CK, Chabner BA. Review. Pharmacologically guided phase I clinical trials based upon preclinical drug development. JNCI 1990; 1321-1326.
24. Gammans RE, Westrick ML, Shea, JP, Mayol RF, Labudde, JA. Pharmacokinetics of buspirone in elderly subjects. J. Clin. Pharmacol. 1989; 29:72-78.
25. Goa KL, Ward A. Buspirone, a preliminary review of its pharmacological properties and therapeutic efficacy as an anxiolytic. Drugs, 1986; 32:114-129.
26. Della Paschoa OE, Kruk MR, Danhof M. Pharmacokinetic-pharmacodynamic modelling of behavioural responses. Neurosci Biobehav Rev 1998; 23:229-236.
27. Reigner BG, PEO W, Patel IH, Steimer JL, Peck C, Van Brummelen P. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Clin Pharmacokinet 1997; 33(2):142-152.
28. Van Peer A, Snoeck E, Huang ML, Heykants J. Pharmacokinetic-pharmacodynamic relationships in Phase I/Phase II of drug development. Eur J Drug Metab Pharmacokinet 1993; 18(1):49-59.
29. Egan TD, Minto CF, Hermann DJ et al. Remifentanil versus alfentanil: comparative pharmacokinetics and pharmacodynamics in healthy adult male volunteers. Anesthesiology 1996; 84:821-833.
30. Kleinbloesem CH, Van Brummelen P, Danhof M, et al. Rate of increase in the plasma concentration of nifedipine as a major determinant of its hemodynamic effects in humans. Clin Pharmacol Ther 1987; 41:20-30.
31. Sheiner L, Beal SL, Sambol NC. Study designs for dose-ranging. Clin Pharmacol Ther 1989; 46:63-77.
32. Bauer LA, Horn JR, Pettit H. Mixed-effect modeling for detection and evaluation of drug interactions: Digoxin-quinidine and digoxin-verapamil combinations. Ther Drug Monit 1996; 18:46-52.
33. McLachlan AJ, Tett SE. Effect of metabolic inhibitors on cyclosporin - A pharmacokinetics studies using a population approach. Ther Drug Monit 1995; 17:400 (abstract 67).
34. Grasela TH, Antal EJ, Ereshefsky L, Wells BG, Evans RL, Smith RB. An evaluation of population pharmacokinetics in therapeutic trials. Part II. Detection of a drug-drug interaction. Clin Pharmacol Ther 1987; 42:433-441.
35. Guentert TW, Banken L, Hilton S, Holford NHG. Moclobemide: Relationships between dose, drug concentration in plasma, and occurrence of adverse events. J Clin Pharmacol 1995; 15:84S:94S.
36. Rombout F. Good Pharmacokinetic Practice (Gpp) and logistics a continuing challenge In: Balant LP and Aarons L. (eds), The population approach: Measuring and managing variability in response, concentration and dose, Commission of the European Communities, European Cooperation in the field of Scientific and Technical Research, Brussels, 1997. in press.
37. Hale M, Gillespie WR, Gupta SK, Tuk B, Holford NH. Clinical trial simulation: streamlining your drug development process. Applied Clinical Trials August 1996; 35-40.
38. Gieschke R, Reigner BG, Steimer JL. Exploring clinical study design by computer simulation based on pharmacokinetic/pharmacodynamic modelling. Int J Clin Pharmacol Therapeut 1997; 35:469-474.
39. Ragueneau I, Laveille C, Jochemsen R, Resplandy G, Funck-Brentano C, Jaillon P. Pharmacokinetic-pharmacodynamic modelling of the effects of ivabradine, a direct sinus node inhibitor, on heart rate in healthy volunteers. Clin Pharmacol Ther 1998; 64:192-203.