International Academic Journals

Plant species genetics, cell culture, Elisa kits, antibodies

A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications (BLAs) for the assessment of target and antidrug antibodies effects

The presence of circulating targets and antidrug antibodies can affect the power of a bioanalytical methodology to measure therapeutic protein (TP) focus related to exposure-response evaluations. This mission surveyed biosimilar submissions for his or her bioanalytical strategies. Survey outcomes revealed that 97% of pharmacokinetic strategies designed to measure theoretically free or partial-free TPs with respect to focus on certainly measured...