title: [Comparison of pharmacokinetic and pharmacodynamic data of interferon-beta 1a preparations after intramuscular and subcutaneous administration].
abstract: Today interferon-beta (IFN-beta) generally is accepted as a therapeutic approach in multiple sclerosis (MS). All human IFN-beta preparations contain interferon in a monomeric, biologically active and inactive polymeric form. Therefore, both the specification of the mass of IFN-beta (microgram) and the biological activity (IU) are used for the characterisation of any particular drug. Nevertheless, not all publications present data on both measurements, apparently resulting in inconsistent statements in some cases. To directly compare pharmacological data from studies distinguishing in methodology or time; only the specification of mass is valid. In Europe, basic pharmacokinetic and pharmacodynamic studies are available from three different IFN-beta 1a preparations. The standard drug, with the brandname Rebif, is clinically tested and approved for treatment in MS. This overview compares results from the three preparations: Rebif, second the so called reference drug, which is the very first IFN-beta 1a clinically tested in MS but unfortunately not approved up to now, and another preparation, which is approved by means of bioequivalence studies only, and therefore called comparison drug here. According to the data available now, it can be stated that the IFN-beta 1a drugs probably show identical results in bioavailability, when given subcutaneously (s.c.) or intramuscularly (i.m.). The data further indicate that all drugs reach the same level of activity in vivo, and will cause identical efficacy, if the same masses are given either s.c. or i.m.
authors.affiliation: Medizinische Poliklinik und Institut für Immunologie der Universität München.
authors.forename: R
authors.initials: R
authors.lastname: Gruber
mesh_terms: D001682:Biological Availability; D005060:Europe; D006801:Humans; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000494:pharmacology* / Q000627:therapeutic use
chemical_list: D016899:Interferon-beta; D000068556:Interferon beta-1a
vernacular_title: Vergleich pharmakokinetischer und pharmakodynamischer Daten von Interferon-beta 1a-Präparaten nach intramuskulärer und subkutaner Applikation.