R-SABE and ABEL versus Blood Volume [Design Issues]
Hi to everybody.
RSABE and ABEL came to aid in studies of HVDs/ HVDPs, but what must we do when we are dealing with a fixed dose combination (FDC) that has, for instance, 3 drugs with different PK, and consequently different blood sampling schedule, and one of the drugs is a HVD?
Take Clorpheniramine + Phenylephrine + Paracetamol as a example. We are worried with Phenylephrine's ISCV and want to use the ABEL approach for it, but for the other 2 drugs we don't feel that there is need for that. If I use a replicated design, even a 3-period one, the sampling schedule is very compromised. In Brazil we have a limit of 530mL of blood per study, so no more than that can be withdrawn from the subjects in the entire study.
So my question is: is it possible to not use the replicated samples for the other 2 drugs and apply conventional ABE for them, and consider the replication only for the HVD? Does that make sense? For me this seems a bit bizarre and questionable, in ethics and in GxP. Other option would be to use Balaam's 4x2 design, but I don't think that someone has budget for that...
THX in advance.
Lucas
RSABE and ABEL came to aid in studies of HVDs/ HVDPs, but what must we do when we are dealing with a fixed dose combination (FDC) that has, for instance, 3 drugs with different PK, and consequently different blood sampling schedule, and one of the drugs is a HVD?
Take Clorpheniramine + Phenylephrine + Paracetamol as a example. We are worried with Phenylephrine's ISCV and want to use the ABEL approach for it, but for the other 2 drugs we don't feel that there is need for that. If I use a replicated design, even a 3-period one, the sampling schedule is very compromised. In Brazil we have a limit of 530mL of blood per study, so no more than that can be withdrawn from the subjects in the entire study.
So my question is: is it possible to not use the replicated samples for the other 2 drugs and apply conventional ABE for them, and consider the replication only for the HVD? Does that make sense? For me this seems a bit bizarre and questionable, in ethics and in GxP. Other option would be to use Balaam's 4x2 design, but I don't think that someone has budget for that...

THX in advance.
Lucas
Complete thread:
- R-SABE and ABEL versus Blood VolumeLucas 2015-08-11 16:06 [Design Issues]
- R-SABE and ABEL versus Blood Volume Helmut 2015-08-11 16:41
- R-SABE and ABEL versus Blood Volume Lucas 2015-08-11 17:04
- R-SABE and ABEL versus Blood Volume Helmut 2015-08-11 17:31
- R-SABE and ABEL versus Blood Volume Lucas 2015-08-11 18:26
- R-SABE and ABEL versus Blood Volume Helmut 2015-08-11 17:31
- R-SABE and ABEL versus Blood Volume Lucas 2015-08-11 17:04
- R-SABE and ABEL versus Blood Volume Helmut 2015-08-11 16:41