Affiliation:
1. Johnson & Johnson Innovative Medicine Scientific Affairs Titusville NJ USA
2. Johnson & Johnson Innovative Medicine Clinical Pharmacology and Pharmacometrics Titusville NJ USA
3. Pfizer Worldwide Research Development and Medical Clinical Pharmacology and Bioanalytics San Diego CA USA
4. Bayer AG Pharmaceuticals, Research & Development Pharmacometrics/Modeling & Simulation Wuppertal Germany
5. Relay Therapeutics Clinical Pharmacology Cambridge MA USA
6. Bristol‐Myers Squibb Global Scientific and Regulatory Documentation Princeton NJ USA
Abstract
AbstractObesity 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.
Subject
Pharmacology (medical),Pharmacology