When outsourcing drug development and manufacturing, how involved should the CEOs of emerging biopharma be in the requisite day-to-day activities and processes? Louis Garguilo interviews …

A challenge in anticipating generic entry is elucidating which patents and regulatory protections constrain generic entry. Yali Friedman at DrugPatentWatch, presents a set of an …

Regulatory bodies expect that pharmaceutical companies have a Contamination Control Strategy (CCS) in place that outlines the control of contamination of utilities, manufacturing systems and …

The system infrastructure for the creation, storage and management of electronic data has to be in place. If this isn’t the case, then completing a …

Bioavailability is defined as the fraction of drug reaching systemic circulation following absorption in the gut and first-pass metabolism in the liver. Accurately predicting the …