Bioequivalence and Bioavailability Forum

Dear All,

I had read the forum's terms and conditions, also searched the threads related to my query prior to registration, As i am in protocol preparation for BA BE studies and the forum is very helpful for me and i used to visit the forum daily.

here my query is,

Shall i go for a replicated design (i.e partial or full) to a combination of drugs, in which one is highly variable and the other is a normal one.

For Eg. Valsartan and Amlodipine

Valsartan is a highly variable drug ISCV greater than 30 (suported in-house studies, AUSPAR publication and UKPAR results. amlodipine is not.

Though the FDA guidnace is sugesting for a Normal crossover design for the combination. Our submission is for EMEA.

Thanks & Regards,
Naveen Kumar.SR