End study requirements for Brazil submission [Regulatives / Guidelines]

posted by drgunasakaran1  – 2021-07-05 10:15 (326 d 11:22 ago) – Posting: # 22456
Views: 560

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;

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

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