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
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