Pharmacokinetics and pharmacodynamics of interferon beta-1a (IFNβ-1a) in healthy volunteers after intravenous, subcutaneous or intramuscular administration

Clinical Drug Investigation

Volumn 14, Issue 1, 1997, Pages 35-43

  Alam, John ^a   McAllister, Arthur ^a   Scaramucci, James ^a   Jones, Wendy ^a   Rogge, Mark ^a  

^a BIOGEN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA 2 MICROGLOBULIN; BETA1 INTERFERON; BETA1A INTERFERON; NEOPTERIN; RECOMBINANT BETA INTERFERON;

ADULT; AREA UNDER THE CURVE; ARTICLE; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; INFLAMMATION; INJECTION SITE; INTRAMUSCULAR DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; MALE; MYALGIA; NORMAL HUMAN; PAIN; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SUBCUTANEOUS DRUG ADMINISTRATION;

EID: 0030806739     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-199714010-00005     Document Type: Article

References (20)

1. Alam J. Interferon-β treatment of human disease. Curr Op Biotech 1995; 6: 688-91
2. Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular Interferon beta-1 a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996; 39 (3): 285-94
3. Goodkin DE. Interferon beta-1b. Lancet 1994; 344: 1057-60
4. Borden RC, Hawkins MJ, Sielaff KM, et al. Clinical and biological effects of recombinant interferon-β administered intravenously daily in phase I trial. J Interfer Res 1988; 8: 357-66
5. ser in healthy volunteers and its effect on serum neopterin. Pharm Res 1993; 10: 557-67
6. Sarna G, Pertcheck M, Figlin R, et al. Phase I study of recombinant β ser 17 interferon in the treatment of cancer. Cancer Treat Rep 1986; 70 (12): 1365-72
7. Hawkins M, Horning S, Konrad M, et al. Phase I evaluation of a synthetic mutant of β-interferon. Cancer Res 1985; 45: 5914-20
8. Hawkins MJ, Krown SE, Krim ECBM, et al. American cancer society phase I trial of naturally produced β-interferon. Cancer Res 1984; 44: 5934-8
9. Treuner J, Dannecker G, Joester K-E. et al. Pharmacological aspects of clinical stage I/II trials with human beta interferon in children. J Interfer Res 1981; 1 (3): 373-80
10. Liberati AM, Biscottini B, Fizzotti M, et al. A phase I study of human natural interferon-β in cancer patients. J Interfer Res 1989; 9: 339-48
11. Witt PL, Storer BE, Bryan GT, et al. Pharmacodynamics of biological response in vivo after single and multiple doses of interferon-β. J Immunother 1993; 13: 191-200
12. Goldstein D, Sielaff KM, Storer BE, et al. Human biologic response modification by interferon in the absence of measurable serum concentrations: a comparative trial of subcutaneous and intravenous interferon-β serine. J Natl Cancer Inst 1989; 81 (14): 1061-8
13. ser in African green monkeys. J Interfer Res 1993; 13: 111-20
14. WHO Expert Committee of Biological Standardisation. 38th World Health Organization Technical Report, Series 771. 1988; 36-8
15. Gibaldi M, Perrier D. Pharmacokinetics. New York: Marcel Dekker, 1982
16. Liberati AM, Horisberger MA, Palmisano L, et al. Double-blind randomised phase I study on the clinical tolerance and biological effects of natural and recombinant interferon-β. J Interfer Res 1992; 12: 329-36
17. Salmon P, LeCotonnec J-Y, Galazka A, et al. Pharmacokinetics and pharmacodynamics of recombinant human interferon-β in healthy male volunteers. J Interferon Cyto Res 1996; 16: 759-64
18. Paulesu L, Pessina GP, Bocci V. Human β-interferon incubated with muscle homogenate is protected by albumin but not by proteinase inhibitors. Proc Soc Exp Biol Med 1992; 200: 414-7
19. Avonex™ and Betaseron® Product Information. 1997: Physician's Desk Reference
20. Welling PG. Pharmacokinetics. Washington: American Chemical Society, 1986