Study Population

Criteria for BE study population:

  • Min. of 12 subjects
  • 18 years of age/ older (18-55)
  • capable of give informed consent
  • Healthy volunteers ~ less PK variability
  • Use Patients when safety concerns preclude healthy volunteers
  • Non smoker
  • No alcohol & drug abuse history
  • Male & Female
    • Female shouldn’t get pregnant at beginning /durning the study
    • Females only ~ contraceptives
    • Males only ~ Teratogens
  • BMI within 18.5 and 30 kg/m2
  • Review of medical history.
  • History of liver, kidney, hematological functions
  • Test for alcohol & drug abuse to be done
  • An ECG to be done if there is a chance of cause
  • Phenotyping / genotyping of subjects may be considered for safety / PK reasons.

  • In parallel design~ the treatment groups should be comparable (age, weight, sex, ethnic, smoking, metabolic status)
  • If the drug product is predominantly intended to use in elderly-> applicant should include as many subjects as possible at /above age 60 / provide justification if no subject at/above 60 is included in study
  • Adult BE study data can be used to support BE assessment in pediatric patients. But if a drug is predominantly used in child < 6yrs, provide justification that adult BE study data is relevant to pediatric patients
  • Justification should include inactive ingredients that they are safe for pediatric use


  • Special population > If there is a significant difference in dissolution between test and reference products under a certain condition > drug limited to a specific population
  • Achlorhydric subjects > If there is a significant difference in dissolution between test and reference products at pH 6.8
  • Healthy adult subjects > If there is no significant difference in dissolution between test and reference products at pH 6.8