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RegisterEnd study requirements for Brazil submission [Regulatives / Guidelines]
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;
» 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.
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Complete thread:
- End study requirements for Brazil submission khageswara Rao 2021-07-01 08:43 [Regulatives / Guidelines]
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- End study requirements for Brazil submissiondrgunasakaran1 2021-07-05 10:15
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