The Journal of Clinical Pharmacology This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Effect of Obesity on the Pharmacokinetics and Pharmacodynamics of Anticancer Agents
J Clin Pharmacol. 2023 Nov;63 Suppl 2:S85-S102. doi: 10.1002/jcph.2326.ABSTRACTAn objective of the Precision Medicine Initiative, launched in 2015 by the US Food and Drug Administration and National Institutes of Health, is to optimize and individualize dosing of drugs, especially anticancer agents, with high pharmacokinetic and pharmacodynamic variability. The American Society of Clinical Oncology recently reported that 40% of obese patients receive insufficient chemotherapy doses and exposures, which may lead to reduced efficacy, and recommended pharmacokinetic studies to guide appropriate dosing in these patients. These...
Source: The Journal of Clinical Pharmacology - November 9, 2023 Category: Drugs & Pharmacology Authors: William C Zamboni Rosane Charlab Gilbert J Burckart Clinton F Stewart Source Type: research

Is There a Need for a Dedicated Pharmacokinetic Trial for a Drug in Obese Populations? A Drug Prioritization Decision Tree Framework
J Clin Pharmacol. 2023 Nov;63 Suppl 2:S48-S64. doi: 10.1002/jcph.2304.ABSTRACTObesity is a growing global health concern associated with high comorbidity rates, leading to an increasing number of patients who are obese requiring medication. However, clinical trials often exclude or under-represent individuals who are obese, creating the need for a methodology to adjust labeling to ensure safe and effective dosing for all patients. To address this, we developed a 2-part decision tree framework to prioritize drugs for dedicated pharmacokinetic studies in obese subjects. Leveraging current drug knowledge and modeling techniqu...
Source: The Journal of Clinical Pharmacology - November 9, 2023 Category: Drugs & Pharmacology Authors: Brooke Langevin Jogarao V S Gobburu Mathangi Gopalakrishnan Source Type: research

Model-Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective
J Clin Pharmacol. 2023 Nov;63 Suppl 2:S65-S77. doi: 10.1002/jcph.2349.ABSTRACTObesity, which is defined as having a body mass index of 30 kg/m2 or greater, has been recognized as a serious health problem that increases the risk of many comorbidities (eg, heart disease, stroke, and diabetes) and mortality. The high prevalence of individuals who are classified as obese calls for additional considerations in clinical trial design. Nevertheless, gaining a comprehensive understanding of how obesity affects the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of drugs proves challenging, primarily as obese patients are...
Source: The Journal of Clinical Pharmacology - November 9, 2023 Category: Drugs & Pharmacology Authors: Xiaolei Pan Li Wang Jiang Liu Justin C Earp Yuching Yang Jingyu Yu Fang Li Youwei Bi Atul Bhattaram Hao Zhu Source Type: research

Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities
J Clin Pharmacol. 2023 Nov;63 Suppl 2:S10-S17. doi: 10.1002/jcph.2327.ABSTRACTThe prevalence of obesity has grown tremendously in recent years and this population has an increased risk of disease comorbidities. The presence of disease comorbidities requires treatment interventions and proper dosing guidelines. However, drug development programs often do not have adequate representation of individuals who are obese in clinical trials, leaving gaps in the understanding of treatment response leading to a lack of adequate individualization options. Based on a recent survey of approved drug product package inserts, very few app...
Source: The Journal of Clinical Pharmacology - November 9, 2023 Category: Drugs & Pharmacology Authors: Jayabharathi Vaidyanathan Elimika Pfuma Fletcher Anuradha Ramamoorthy Rajanikanth Madabushi Gilbert J Burckart Source Type: research

Obesity Considerations in Pediatric Drug Development, 2016-2021
J Clin Pharmacol. 2023 Nov;63 Suppl 2:S18-S24. doi: 10.1002/jcph.2305.ABSTRACTPediatric obesity is a global public health concern. Obesity-related physiological changes may affect the pharmacokinetics of drugs and lead to therapeutic failure or toxicities. An earlier review of pediatric drug development programs from 2007 to 2016 found that, of 89 programs listing obesity-related terms, only 4 (4%) products described pharmacokinetic changes associated with obesity. This review examined obesity considerations for 185 drug products for which pediatric drug development programs were submitted to the US Food and Drug Administr...
Source: The Journal of Clinical Pharmacology - November 9, 2023 Category: Drugs & Pharmacology Authors: Sherbet Samuels Varsha Bhatt-Mehta Kyunghun Park Gilbert J Burckart Source Type: research

Estimation of Absolute and Relative Body Fat Content Using Noninvasive Surrogates: Can DXA Be Bypassed?
J Clin Pharmacol. 2023 Nov;63 Suppl 2:S35-S47. doi: 10.1002/jcph.2306.ABSTRACTDual-energy x-ray absorptiometry (DXA) scanning is used for objective determination of body composition, but instrumentation is expensive and not generally available in customary clinical practice. Anthropometric surrogates are often substituted as anticipated correlates of absolute and relative body fat content in the clinical management of obesity and its associated medical risks. DXA and anthropometric data from a cohort of 9230 randomly selected American subjects, available through the ongoing National Health and Nutrition Examination Survey,...
Source: The Journal of Clinical Pharmacology - November 9, 2023 Category: Drugs & Pharmacology Authors: David J Greenblatt Christopher D Bruno Jerold S Harmatz Bess Dawson-Hughes Qingchen Zhang Chunhui Li Christina R Chow Source Type: research

Clinical Consequences of Altered Drug Disposition in Obesity: Call for Change
J Clin Pharmacol. 2023 Nov;63 Suppl 2:S25-S34. doi: 10.1002/jcph.2308.ABSTRACTObesity is a serious condition with many known comorbid conditions and other health risks. Despite the rising global rates of obesity, drug disposition in this population is typically understudied, which results in limited information guiding the use of drugs in patients with obesity. Presently, dosing adjustments for patients with obesity typically focus on addressing altered drug clearance with body size and are therefore limited to chronic dosing recommendations. These instructions are variable and rarely based on dedicated studies in people w...
Source: The Journal of Clinical Pharmacology - November 9, 2023 Category: Drugs & Pharmacology Authors: Christopher D Bruno David J Greenblatt Jerold S Harmatz Christina R Chow Source Type: research

Child and Adolescent Bariatric Surgery in an Urban Tertiary Center: Special Anesthetic Considerations for Obesity
J Clin Pharmacol. 2023 Nov;63 Suppl 2:S103-S109. doi: 10.1002/jcph.2372.ABSTRACTChildren and adolescents with obesity who present for weight loss surgery are a unique subset of patients. A thorough understanding of the perioperative needs of these individuals is essential to avoid deleterious complications. This review illustrates the necessity for specialized care, including the continued need of specified drug dosing and a systematic approach in the management of the pediatric bariatric patient.PMID:37942911 | DOI:10.1002/jcph.2372 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - November 9, 2023 Category: Drugs & Pharmacology Authors: Janelle D Vaughns Reaundra McCullough-Roach Elaine F Williams Evan P Nadler Source Type: research

The Importance of Assessing Drug Pharmacokinetics and Pharmacodynamics in the Obese Population During Drug Development
J Clin Pharmacol. 2023 Nov;63 Suppl 2:S78-S84. doi: 10.1002/jcph.2361.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 c...
Source: The Journal of Clinical Pharmacology - November 9, 2023 Category: Drugs & Pharmacology Authors: Kenneth T Moore Peter N Zannikos Joanna C Masters Stefan Willmann Jinshan Shen Charles Frost Source Type: research

Population Pharmacokinetics of Caffeine in Neonates with Congenital Heart Disease and Associations with Acute Kidney Injury
This article is protected by copyright. All rights reserved.PMID:37933788 | DOI:10.1002/jcph.2382 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - November 7, 2023 Category: Drugs & Pharmacology Authors: Elizabeth J Thompson Kanecia O Zimmerman Daniel Gonzalez Henry P Foote Sangah Park Kevin D Hill Jillian H Hurst Chi D Hornik Reid C Chamberlain Rasheed A Gbadegesin Christoph P Hornik Source Type: research

Population pharmacokinetics of ozoralizumab in patients with rheumatoid arthritis
This article is protected by copyright. All rights reserved.PMID:37909264 | DOI:10.1002/jcph.2380 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - November 1, 2023 Category: Drugs & Pharmacology Authors: Tsutomu Takeuchi Yukihiro Chino Yoko Mano Masafumi Kawanishi Yuri Sato Saeko Uchida Yoshiya Tanaka Source Type: research

Physiologically-based pharmacokinetic modeling of nilotinib for drug-drug interactions, pediatric patients, and pregnancy and lactation
This article is protected by copyright. All rights reserved.PMID:37909674 | DOI:10.1002/jcph.2379 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - November 1, 2023 Category: Drugs & Pharmacology Authors: Xiaomei I Liu Ruby Leong Gilbert J Burckart Andr é Dallmann Source Type: research

Hypokalemia and hyponatremia in adult patients receiving voriconazole therapeutic drug monitoring
In conclusion, hypokalemia is more likely to occur in females, patients receiving intravenous VCZ, and patients with combined use of antibiotics. Hyponatremia is more likely to occur in patients older than 47 years who have been using VCZ for a long time and have higher VCZ C0 . This article is protected by copyright. All rights reserved.PMID:37910022 | DOI:10.1002/jcph.2381 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - November 1, 2023 Category: Drugs & Pharmacology Authors: Lin Cheng Zhirui Liu Mingjie Yu Ling Lin Lirong Xiong Qing Dai Source Type: research