Bioequivalence and Bioavailability Forum

Dear All,

Could you please confirm me whether US FDA have any guidelines or particular opinion about retention period of plasma samples. (As far as my knowledge is concerned there are no set criteria for retention of plasma samples for US submission).

I have gone through one of the post under the same thread. It gives information only about Canada. Also I have refered 21 CFR part 320, US FDA guidelines etc. I could not get any information regarding the same.

Also we are planning to submit ANDA to EU market very soon. If possible please provide guidelines (if any) on the above subject.

Thanks a lot in advance.

Preet.