Bioequivalence and Bioavailability Forum

Dear Mr Khageswara Rao,

» what are all the requirements for post study in babe studies for Brazil submission.

As per RESOLUÇÃO - RDC Nº 41, we need to repeat all the following screening laboratory parameters except serology in the post study period.

- Twelve-lead electrocardiogram;
- Complete blood count;
- Urea;
- Creatinine;
- Alkaline phosphatase;
- Blood glucose;
- Total bilirubin;
- Total proteins and albumin;
- Oxaloacetic and pyruvic transaminase;
- Uric acid;
- Total cholesterol;
- Triglycerides;
- Type I urine (routine urine);
- Beta HCG (for women);
- Serology for hepatitis B, C and HIV;