title: About the equivalence between different batches of a glycopeptide drug.
abstract: BACKGROUND
  Teicoplanin is a glycopeptide antibiotic consisting of a combination of different active components. Clinical equivalence between different batches of this drug is not guaranteed by the present pharmacopeial specification of chemical composition based on an HPLC chromatogram.
  
  
  OBJECTIVE
  To test a modification of this specification and to evaluate independent compositions recently published in the literature.
  
  
  METHODS
  The expectable area under the plasma curve of each batch has been estimated based on its chemical composition as described in a former paper. Batch-comparisons are based on ratios between the area of the test batch and the area of a reference.
  
  
  CONCLUSIONS
  The modification of this specification recently proposed by the European Medicines Agency (EMA) has been tested confirming its goodness. A new acceptance range of AUC variation, rounding -10% to +15%, has been obtained. It is narrower than the current interval of the pharmacopeial specification. Concerning the generic batches that have been studied, the majority of differences with the reference is lower than ±10%. Variations in the compositions of the reference product have been observed to influence the results and a control criteria are proposed.
  
  
  CONCLUSIONS
  The variability of the pharmacokinetic performance of teicoplanin can be better controlled with this new proposal of composition specification given by EMA.
authors.affiliation: a Departamento de Farmacia y Tecnologia Farmacéutica , Facultad de Farmacia/Universidad de Barcelona , Barcelona , Spain and.
authors.forename: Antonio
authors.initials: A
authors.lastname: Boix-Montañes
authors.affiliation: b División de Farmacología y Evaluación Clínica, Departamento de Medicamentos de Uso Humano , Agencia Española de Medicamentos y Productos Sanitarios , Madrid , Spain.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Garcia-Arieta
mesh_terms: D000900:Anti-Bacterial Agents / Q000032:analysis / Q000737:chemistry / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards*; D016568:Drugs, Generic / Q000032:analysis / Q000737:chemistry / Q000493:pharmacokinetics; D006020:Glycopeptides / Q000032:analysis / Q000737:chemistry / Q000493:pharmacokinetics*; D017334:Teicoplanin / Q000032:analysis / Q000737:chemistry / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D016568:Drugs, Generic; D006020:Glycopeptides; D017334:Teicoplanin
keywords: Analytical specification; pharmacopeia; relative bioavailability; teicoplanin