khageswara Rao ☆ India, 2021-07-01 08:43 (404 d 23:00 ago) Posting: # 22446 Views: 827 |
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Hii all, what are all the requirements for post study in babe studies for Brazil submission. |
drgunasakaran1 ★★ ![]() 2021-07-05 10:15 (400 d 21:28 ago) @ khageswara Rao Posting: # 22456 Views: 612 |
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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. |