Advances in paediatric pharmacokinetics

Areas covered in this review: Constraints in paediatric studies result in data sets with specific characteristics requiring advanced analysis and validation approaches which are discussed in conjunction with directions for future research. What the reader will gain: Advances have been made in the development of descriptive paediatric pharmacokinetic models for specific drugs and age ranges, and in the identification of analysis and diagnostic tools for paediatric model building and evaluation, while sharing of data between academia and/or industry has proven crucial for limiting additional burden in children. Even though progress is being made, currently none of the scaling approaches has proven of universal value for extrapolations to other age ranges and/or other drugs. Take home message: The focus of future research should be on the development of mechanistic and validated pharmacokinetic models for specific elimination routes that have predictive and extrapolation potential, making them of use in designing algorithms to derive first-time-in-child doses and individualised dosing guidelines in paediatrics.