Pharmaceutical Regulatory Affairs: Open Access

Schramm F

Publications

• Research Article
  Group A2 Analogs of Innovator Teicoplanin: Variability of their Ratio during Treatment Time Course in Human Blood; Consequences for the Generics
  Author(s): Jehl F, Schramm F, Colombo P and Brink AJJehl F, Schramm F, Colombo P and Brink AJ
  
  Absence of therapeutic equivalence (TE) of generic antibiotics versus the innovator has been reported, even in case of pharmaceutical equivalence (PE).The pharmaceutically active principle of teicoplanin is mainly represented by the A2 group analogs (A2-1 to A2-2) which exist in given ratios in the innovator. We studied the evolution of these ratios in humans volunteers receiving 2 dosage regimen (6mg/kg IV every 12 hours, 3 times, and then 6 mg/kg per day for ten days - group1-, and 12 mg/kg IV every 12h, 3 times, followed by 15 mg/kg every other day till D11 - group 2-), by a specific HPLC methodology, after single dose (D1) and at steady state at day 11.. Read More»
  DOI: 10.4172/2167-7689.1000112

  Abstract PDF