Bioequivalence and Bioavailability Forum

❝ • Urine: History. Haven’t seen a method (in BE of course; PK is another cup of tea) for ages. BE based on urine data is only reasonable if the drug is excreted unchanged (low first pass and/or presystemic metabolization). Was used for bisphosphonates in the past (BA <2%). Since it is very difficult to assess the rate of absorption from urine, EMA accepted extent of absorption from urine (cumulative amount) but still wanted to see C_max from plasma.