Bioequivalence Study Process
Protocol Development
Literature review, Study design (synopsis)
Case report form
Informed consent form
EC submission & approval
Apply import permit (Nor Yor Mor 1)
Apply Phor Yor 8
Clinical activity
Recruitment
Screening
Enrollment
Data management
Bioanalysis
Method Development
Method Validation (Pre-study validation)
Plasma drug level analysis (Study phase)
PK & Statistical analysis
Pharmacokinetic (PK) analysis
Statistical analysis
BE study report
PK & Statistic evaluation
Efficacy & safety evaluations