End study requirements for Brazil submission [Regulatives / Guidelines]
❝ 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;
- Alkaline phosphatase;
- Blood glucose;
- Total bilirubin;
- Total proteins and albumin;
- Oxaloacetic and pyruvic transaminase;
- Uric acid;
- Total cholesterol;
- Type I urine (routine urine);
- Beta HCG (for women);
- Serology for hepatitis B, C and HIV;
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.