Pediatric Extrapolation | KinderPharm
Companies are required to provide “substantial evidence” that a drug is effective according to the Federal Food and Drug Cosmetic Act (1962). These requirements are generally met by conducting at least 2 adequate and well controlled trials. However, the FDA and EMA have afforded some flexibility to allow (under certain circumstances) the extrapolation of a data from adults to pediatric patients. This approach can reduce the number of pediatric patients needed in clinical trials.
A range of available options
If efficacy has not been demonstrated in adults or other pediatric patients the extrapolation of efficacy cannot be justified and adequate and well controlled trials in pediatric patients will be needed. Typically however, there are usually a range of options available based on the availability of existing data that can help support the decision to adopt a “No Extrapolation”, “Partial Extrapolation” or “Full Extrapolation” approach.
KinderPharm’s experienced pediatrician’s and clinical pharmacologist’s can help you assess the available data and determine the best way to approach to minimize the burden of conducting trials in patients and provide the most efficient and cost effective approach to meet the regulatory requirements for pediatric labelling.
Contact us with any questions you may have on pediatric extrapolation.