Pharmacokinetic/pharmacodynamic model analysis of pegylated interferon α-2a in healthy subjects

Japanese Journal of Clinical Pharmacology and Therapeutics

Volumn 34, Issue 4, 2003, Pages 177-185

  Shiomi, Mari ^a   Funaki, Tomoo ^a  

^a NIPPON ROCHE RESEARCH CENTER   (Japan)

Author keywords

2 ,5 oligoadenylate synthetase; Healthy subjects; Pegylated interferon 2a; PK PD modeling

Indexed keywords

2',5' OLIGOADENYLATE SYNTHETASE; ALPHA2A INTERFERON; NONOXINOL 9; PEGINTERFERON ALPHA2A;

ADULT; ANALYSIS OF VARIANCE; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BINDING KINETICS; BLOOD SAMPLING; CLINICAL TRIAL; CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION COEFFICIENT; DISEASE MARKER; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG EXPOSURE; DRUG HALF LIFE; DRUG RECEPTOR BINDING; ENZYME ACTIVITY; ENZYME INDUCTION; HUMAN; HYSTERESIS; MALE; NORMAL HUMAN; PHARMACODYNAMICS; RACE DIFFERENCE;

EID: 0041512950     PISSN: 03881601     EISSN: None     Source Type: Journal    
DOI: 10.3999/jscpt.34.4_177     Document Type: Article

References (24)

1. Breimer DD, Danhof M. Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The 'Wooden Shoe' paradigm. Clin Pharmacokinet 1997; 32: 259-67.
2. Reigner BG, Williams PEO, Patel IH, Steimer J-L, Peck C, van Brummelen P. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience within Hoffmann La Roche. Clin Pharmacokinet 1997; 33: 142-52.
3. Levy G. Predicted effective drug concentrations for individual patients. Clin Pharmacokinet 1998; 34: 323-33.
4. Derendorf H, Meibohm B. Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: concepts and perspectives. Pharm Res 1999; 16: 176-85.
5. Wada JR, Karlsson MO. Combining PK and PD data during population PK/PD analysis. Population Approach Group in Europe Eighth Meeting in Saintes. France, 1999.
6. Zeuzem S, Feinman SV, Rasenack J, et al. Peginterferon alfa-2a in patients with chronic hepatitis C. N Engl J Med 2000; 343: 1666-72.
7. Wills RJ. Clinical pharmacokinetics of interferons. Clin Pharmacokinet 1990; 19: 390-9.
8. Nucci ML, Shorr R, Abuchowski A. The therapeutic value of poly (ethylene glycol)-modified proteins. Adv Drug Delivery Rev 1991; 6: 133-51.
9. Yang P-M, Wang J-T, Chiang B-L, Lai M-Y, Chen D-S. Serum 2′,5′-oligoadenylate synthetase concentrations in acute and chronic hepatitis C. J Formos Med Assoc 1997; 96: 314-9.
10. Khakoo S, Glue P, Grellier L, et al. Ribavirin and interferon alfa-2b in chronic hepatitis C: assessment of possible pharmacokinetic and pharmacodynamic interactions. Br J Clin Pharmacol 1998; 46: 563-70.
11. Piscitelli SC, Reiss WG, Figg WD, Petros WP. Pharmacokinetic studies with recombinant cytokines: scientific issues and practical considerations. Clin Pharmacokinet 1997; 32: 368-81.
12. Nieforth KA, Nadeau R, Patel IH, Mould D. Use of an indirect pharmacodynamic stimulation model of MX protein induction to compare in vivo activity of interferon alpha-2a and a polyethylene glycol-modified derivative in healthy subjects. Clin Pharmacol Ther 1996; 59: 636-46.
13. Sugino H, Mitani I, Koike M, Kodama T, Sokawa J, Sawai H, Ishibashi K, Itoh M, Watanabe S, Sokawa Y. Detection of elevated levels of 2-5A synthetase in serum from children with various infections diseases. J Clin Microbiol 1986; 24: 478-48.
14. nd ed. NY: Marcel Dekker Inc, 1982: 149-52.
15. Jusko WJ, Ko HC. Physiologic indirect response models characterize diverse types of pharmacodynamic effects. Clin Pharmacol Ther 1994; 56: 406-19.
16. WinNonlin User's Guide. Mountain View, CA. USA: Pharsight Corporation, 1998.
17. Koura T, Kato Y, Unoura M. 2-5 oligoadenylate synthetase. Nippon Rinsho 1995; 53: 202-5.
18. Sokawa Y. Antiviral action of interferon - 2,5 a system -. Immunopharma Ther 1983; 1: 80-8.
19. Chatelut E, Rostaing L, Gregoire N, Payen J-L, Pujol A, Izopet J, Houin G, Canal P. A pharmacokinetic model for alpha interferon administered subcutaneously. Br J Clin Pharmacol 1999; 47: 365-71.
20. Xu Z-X, Rakhit A, Patel IH, van Brummelen P. PK/PD modeling approach to support clinical development of a long-acting interferon (Ro25-3036) for the treatment of chronic hepatitis C. Clin Pharmacol Ther 1998; 63: 162.
21. Ethnic Factors in The Acceptability of Foreign Clinical Data E5. ICH Harmonised Tripartite Guideline, 1998.
22. Funaki T. Enterohepatic circulation model for population pharmacokinetic analysis. J Pharm Pharmacol 1999; 51: 1143-8.
23. Xu Z-X, Hoffman J, Patel I, Joubert P. Single-dose safety/tolerability and pharmacokinetic/pharmacodynamics (PK/PD) following administration of ascending subcutaneous doses of pegylated-interferon (PEG-IFN) and interferon α-2a (IFN α-2a) to healthy subjects. Hepatology 1998; 28(Suppl): 702A.
24. Hoffman-La Roche Inc. personal communication.