Analytical method [Bioanalytics]
Dear Members,
I have one example of bioanalytical method for one Fixed dose combinaion of Two drug A & B, which is having the same extraction (Protein ppt method) method for both the drug.
In recovery study i am getting a trend, Drug A has the recovery (89, 92, 97 for High, med & low concentration), while for Drug B the recovery is (75, 68, 63 for high, mid & low conc.).
I am getting matrix factor in between 0.5 to 0.7. Both Drug is not having any active metabolite, but have metabolites.
Do I need to improve the method or I can go ahead for method validation.
Your view in this regard is appreciable.
Thanks for your answers
I have one example of bioanalytical method for one Fixed dose combinaion of Two drug A & B, which is having the same extraction (Protein ppt method) method for both the drug.
In recovery study i am getting a trend, Drug A has the recovery (89, 92, 97 for High, med & low concentration), while for Drug B the recovery is (75, 68, 63 for high, mid & low conc.).
I am getting matrix factor in between 0.5 to 0.7. Both Drug is not having any active metabolite, but have metabolites.
Do I need to improve the method or I can go ahead for method validation.
Your view in this regard is appreciable.
Thanks for your answers