Establishing PK biocomparability continues to be an important challenge for the pharmaceutical and biotech industry. Overcoming the challenges within biologic therapeutics have led to many innovative bioanalytical approaches. One such approach was using a monoclonal antibody called siltuximab.

Today, we wanted to share a presentation deck titled “An Innovative Approach for Effective Clinical Evaluation of PK Biocomparability” from Chao Han at J & J. Mr Han delivered this talk at one of our past Controlled & Modified Drug Summits. This presentation will give a brief overview of regulatory requirements, current practice & challenges for biologics and present data on an innovative approach using siltuximab, including presenting the results of a PoC animal study

Scroll through the presentation below……