Individualization of drug therapy requires that the right drug be administered at the correct dose to
patients who are likely to achieve the highest benefit and lowest risk. Female sex and age comprise two
important risk factors for altered drug exposure and response. This review summarizes the current state
of science for considering age and sex-related factors along the drug development pipeline, from cell
culture and animal research through all phases of clinical trials in humans. A set of recommendations is
provided to improve standards for integrating age and sex into the study design, analysis, and reporting
of pre-clinical and clinical assessment of new molecular entities and biologics in adults.
© 2017 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license