Tag: pcr8

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

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