(584 d 18:28 ago)
Posting: # 22446
what are all the requirements for post study in babe studies for Brazil submission.
(580 d 16:57 ago)
@ khageswara Rao
Posting: # 22456
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;
- 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
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