American cancer society phase I trial of naturally produced β-interferon. Phase I evaluation of a synthetic mutant of β-interferon. Phase I study of recombinant β ser 17 interferon in the treatment of cancer. Pharmacokinetics of recombinant human interferon-β ser in healthy volunteers and its effect on serum neopterin. J Interfer Res 1988 8: 357–66Ĭhiang J, Gloff CA, Yoshizawa CN, et al. Clinical and biological effects of recombinant interferon-β administered intravenously daily in phase I trial. Lancet 1994 344: 1057–60īorden EC, Hawkins MJ, Sielaff KM, et al. Intramuscular interferon beta-la for disease progression in relapsing multiple sclerosis. Jacobs LD, Cookfair DL, Rudick RA, et al. These results indicate that the optimal pharmacokinetic response is produced by intramuscular, rather than subcutaneous or intravenous, administration of IFNβ-1a.Īlam J. The pharmacodynamic response, as measured by changes in serum neopterin and β 2-microglobulin concentrations, was also greatest after intramuscular injection, followed by subcutaneous, then intravenous administration. The area under the curve for serum interferon activity was 2- to 3-fold higher after intramuscular injection than after subcutaneous injection. After intramuscular injection, peak serum interferon activity levels were approximately 40 U/ml and occurred 12 to 18 hours post-administration.
Interferon activity was consistently detectable in serum after intramuscular injection but not after subcutaneous injection. The mean volume of distribution of the central compartment was 61.6L and the mean total clearance was 334 ml/h/kg. The mean distribution and elimination half-lives were 4 minutes and 4 hours, respectively. Serum interferon activity levels peaked immediately after the end of the intravenous infusion and thereafter fit a bioexponential decay model. Three groups, each consisting of 8 healthy male and female subjects, received a single 60μg (12 million units) dose of IFNβ-1a by either a 30-minute intravenous infusion, or by subcutaneous or intramuscular injection. The objective of this study was to define the single-dose pharmacokinetics and pharmacodynamics of interferon beta-la (IFNβ-1a) after various routes of administration.
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