The approved drug label is the official description of a drug product and includes what the drug is used for, who should take it, side effects, instructions for use, and safety information for clinicians and patients. For drug companies, the label is the culmination of years of work and millions, if not billions of dollars. Every element, word, and comma in the label will impact the potential patient population that can benefit from that new drug, while detailing any associated risks, including staying “silent” when information is not available. In other words, what is included or excluded from the label will affect the overall profit potential of the drug.
While modeling and simulation has been an important element in drug development for some time, its impact over the past two years with regard to labeling has been profound. Specifically, FDA’s acceptance of physiologically-based pharmacokinetic (PBPK) modeling and simulation has impacted key label elements in more than twenty cases, driving down R&D costs and timelines, and increasing the likelihood of both clinical trial and regulatory success.