Hi Everyone,
Can anyone point out some guidelines as to when bench and animal studies are no longer sufficient and human trail is required?
I haven't seen any official guidance document on this subject.
Specific to our case, we have a series of tests to perform and for one of them we don't have enough of clinical (human) data, but we have retrospective animal data that we can use. Obviously, we want to avoid going for IRBs or IDE study.
Many Many Thanks,
Shimon
Can anyone point out some guidelines as to when bench and animal studies are no longer sufficient and human trail is required?
I haven't seen any official guidance document on this subject.
Specific to our case, we have a series of tests to perform and for one of them we don't have enough of clinical (human) data, but we have retrospective animal data that we can use. Obviously, we want to avoid going for IRBs or IDE study.
Many Many Thanks,
Shimon