Extemporaneous Formulations: Comparison with Labeled Pediatric Formulations

摘要

Regulatory changes have resulted in the inclusion of clinical studies with pediatric patients as an integral part of pharmaceutical product development. In the US, the FDA guidance for pediatric drug development is provided by the BPCA [1] and PREA [2]. These regulations [3] apply to any NDA, new indication, new pharmaceutical form, or new route of administration. The product specific requirements are outlined in a written request which is issued by the FDA. The EU pediatric regulations [4,5] apply under similar product filing conditions but require the submission of a pediatric investigational plan (PIP) no later than upon completion of human pharmacokinetic studies in adults. This requirement shifts the planning for pediatric studies to earlier points in product development, sometimes in advance of selecting doses for adults. Milne et a.I [6] describe the pediatric patient population as a continuum of as many as six smaller populations with different requirements for optimum dosing and for product administration. The pediatric population includes preterm infants, neonates, infants and toddlers, preschool and school aged children and adolescents. The development of formulations, the clinical studies within the various populations and the supply of these products to the market are the key challenges which may require 'out of the box' thinking to provide for pediatric patient populations. Labeled pediatric formulations and industry verified (extemporaneous) preparations [7] are options to fulfill pediatric needs.