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Review
. 2017 Jul:121:83-93.
doi: 10.1016/j.phrs.2017.04.027. Epub 2017 Apr 26.

Age and sex in drug development and testing for adults

Cara Tannenbaum  1 , Danielle Day  2 ; Matera Alliance
Affiliations
Free article
Review

Age and sex in drug development and testing for adults

Cara Tannenbaum et al. Pharmacol Res. 2017 Jul.
Free article

Abstract

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.

Keywords: Age; Clinical trials; Dofetilide (PubChem CID: 71329); Drug discovery; Experimental design; Ondansetron (PubChem CID: 4595); Propranolol (PubChem CID: 4946); Quinidine (PubChem CID: 441074); Sex; Tirilazad (PubChem CID: 104903); Zolpidem (PubChem CID: 5732).

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