Age and sex in drug development and testing for adults

[Display omitted] 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 s...

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Bibliographic Details
Published in:Pharmacological research 2017-07, Vol.121, p.83-93
Main Authors: Tannenbaum, Cara, Day, Danielle
Format: Article
Language:English
Subjects:
Age
Age Factors
Animals
Clinical trials
Clinical Trials as Topic
Drug discovery
Drug Discovery - methods
Experimental design
Female
Humans
Male
Research Design
Sex
Sex Factors
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Description
Summary:[Display omitted] 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.
ISSN:1043-6618
1096-1186
DOI:10.1016/j.phrs.2017.04.027