Regulatory agencies expect nonclinical and clinical data to be presented and summarized in a consistent manner across all sponsors. This applies to the investigational new drug (IND) application in the US as well as the drug approval applications [biologics license application (BLA) and new drug ...

Immune responses in the patient population during clinical trials or post-market are a serious issue facing biologic therapeutics. Regulatory agencies expect biopharmaceutical/pharmaceutical companies to fully assess the potential for immunogenicity in large molecule therapeutics. Understanding a...

Basic concepts in development and validation of assays for pharmacokinetic analysis continue to be a constant presence in an evolving pharmaceutical industry. Even with the advent of new modalities, such as bi-specific antibody drugs and oligonucleotide drugs, the process to develop and validate ...