Suitable matrix? [Study Performance]
Dear both,
I’m aware that both the FDA (in a guidance) and the EMA (in current practice) ask for measurement in serum. We all know that serum (or plasma) concentrations are a surrogate of the concentrations at the site of action (which in general is not accessible).
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.
Just my 2 ¢.
On another note using stable isotope labelled products (57Fe and/or 58Fe) could help in distinguishing endogenous from dosed Fe.
I’m aware that both the FDA (in a guidance) and the EMA (in current practice) ask for measurement in serum. We all know that serum (or plasma) concentrations are a surrogate of the concentrations at the site of action (which in general is not accessible).
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.
Just my 2 ¢.
On another note using stable isotope labelled products (57Fe and/or 58Fe) could help in distinguishing endogenous from dosed Fe.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Iron Sucrose Bioequivalence Alexander 2015-06-29 10:55
- 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