BE with intravenous solutions? [Design Issues]
Dear Raghav
IMHO the question you need to answer is not bioequivalence but interaction. First you have to ensure in vitro that your combi formulation is as stable as both mono formulations and that both APIs do not interact chemically.
From a clinical point of view you first have to decide if it is reasonable to administer both compounds at the same time. If yes it is interesting to know if there is a pharmacological interaction. To investigate this you need a bioavailability (interaction) study with the following design:
Randomised 3 way 3 period cross-over
Treatment A: mono formulation 1
Treatment B: mono formulation 2
Treatment C: kombi formulation (1+2)
I hope this helps.
Kind regards
Dan
IMHO the question you need to answer is not bioequivalence but interaction. First you have to ensure in vitro that your combi formulation is as stable as both mono formulations and that both APIs do not interact chemically.
From a clinical point of view you first have to decide if it is reasonable to administer both compounds at the same time. If yes it is interesting to know if there is a pharmacological interaction. To investigate this you need a bioavailability (interaction) study with the following design:
Randomised 3 way 3 period cross-over
Treatment A: mono formulation 1
Treatment B: mono formulation 2
Treatment C: kombi formulation (1+2)
I hope this helps.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- FDC Ceftriaxone + Vancomycin Injection Formulation raghavendra_s 2011-05-31 11:37
- BE with intravenous solutions? Dr_Dan 2011-05-31 13:03
- BE with intravenous solutions? raghavendra_s 2011-05-31 13:23
- BE with intravenous solutions?Dr_Dan 2011-06-01 11:54
- BE with intravenous solutions? raghavendra_s 2011-05-31 13:23
- BE with intravenous solutions? Dr_Dan 2011-05-31 13:03
