Suitable matrix? [Study Performance]
❝ However, Fe stimulates the production of erythrocytes in the bone marrow (hey, the site of action!) of Fe-deficient patients. In my understanding measuring in whole blood would be more reasonable.
i am wokring on this projects since last 09 years and had communication with EMEA. i personally think that USFDA guidelines is much appropriate which ask you to measure TBI (transferrin bound Iron) and TI (total iron. IN my terms if you prove both passes your product is really bio equivalent. also it is important to note that ICPMS is not the appropriate method).
Complete thread:
- Iron Sucrose Bioequivalence Alexander 2015-06-29 10:55 [Study Performance]
- Iron Sucrose Bioequivalence Ravindra 2015-07-01 15:29
- Suitable matrix? Helmut 2015-07-01 15:53
- Suitable matrix?Ravindra 2015-07-02 08:12
- Suitable matrix? Helmut 2015-07-02 13:35
- Suitable matrix?Ravindra 2015-07-02 08:12
- Suitable matrix? Helmut 2015-07-01 15:53
- Iron Sucrose Bioequivalence Ravindra 2015-07-01 15:29