The Importance of Assessing Drug Pharmacokinetics and Pharmacodynamics in the Obese Population During Drug Development.

Bibliographic Details
Title: The Importance of Assessing Drug Pharmacokinetics and Pharmacodynamics in the Obese Population During Drug Development.
Authors: Moore, Kenneth T., Zannikos, Peter N., Masters, Joanna C., Willmann, Stefan, Shen, Jinshan, Frost, Charles
Source: Journal of Clinical Pharmacology; Nov2023 Supplement 1, Vol. 63, pS78-S84, 7p
Subject Terms: OBESITY complications, OBESITY, DRUG efficacy, BODY weight, DRUG development, BODY mass index, ANTIOBESITY agents, COMORBIDITY, PATIENT safety, PHARMACODYNAMICS, DISEASE risk factors
Geographic Terms: UNITED States
Abstract: Obesity remains a US national health crisis and a growing concern worldwide. Concerningly, individuals who are obese are at an increased risk for comorbid diseases that include, but are not limited to, hypertension, diabetes, cardiovascular disease, and cancer. Beyond the risk for developing these conditions, obesity may also impact the pharmacological activity of the therapies being used to treat them and other disease states. The pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of therapies, both currently marketed and under clinical development, may be directly impacted by the physiological alterations that occur secondary to the occurrence of chronic excess body weight. The increased prevalence of this disease should not be ignored. Both private and federal institutions involved in drug research and development should consider, as appropriate, a greater inclusion of individuals who are obese in clinical trials throughout the entirety of drug development, and leverage the available PK, PD, safety, and efficacy data to make more informed dosing recommendations. [ABSTRACT FROM AUTHOR]
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Database: Complementary Index
More Details
ISSN:00912700
DOI:10.1002/jcph.2361
Published in:Journal of Clinical Pharmacology
Language:English