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Bioequivalence studies / Studies I.-II. phase

 

Type of studies (I-IIa Phase)

Studies of different designs are arranged according sponsor’s requirements and we offer also pharmacokinetic and statical evaluation of the data.

  • Pharmacokinetic studies
  • Toxicokinetic studies (animals)
  • Pharmacodynamic studies including assessment of clinical parameters
  • Bioavailability
  • Bioequivalence studies
  • Dose linearity
  • Different ways of administration/different dosage forms
  • Steady-state studies
  • In vitro bioequivalence/pharmacokinetics
  • In vitro / in vivo correlations
  • Drug, or alcohol interactions
  • Food influence (fasted/fed)
  • Age/gender influence
  • Special population studies