Formulation
The development of an age-appropriate formulation and commitment to commercialization if use of the product is extended to the pediatric population based on study results is a requirement of the WR. Bioavailability of any formulation used in the studies must be characterized, and as needed, a relative bioavailability study comparing the approved drug to the age appropriate formulation may be conducted in adults. Special formulations have been developed for 5 drugs in response to the WRs initiated since 2001. For example, the adult formulation of capecitabine is tablets. Pediatric film-coated tablets were designed to quickly disperse in water so that can be administered to pediatric patients who are unable to swallow tablets. (https://www.fda.gov/media/87706/download).