Pharmaceutical regulatory affairs : open access最新文献

筛选

英文中文

Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity. 儿童和成人肥胖症常用药物的产品标签。

Pharmaceutical regulatory affairs : open access Pub Date : 2019-01-01 Epub Date: 2019-04-12

Kanecia O Zimmerman, Daniel K Benjamin, Mara L Becker, Ravinder Anand, Christoph P Hornik

{"title":"Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity.","authors":"Kanecia O Zimmerman, Daniel K Benjamin, Mara L Becker, Ravinder Anand, Christoph P Hornik","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Obesity is a major public health problem that can affect drug disposition and dosing, particularly in vulnerable pediatric populations. Despite potentially detrimental consequences from inappropriately dosed drugs in children with obesity, drug product labels largely fail to include dosing or guidance specific to this population. Failure to include this information results in an increased incidence of adverse events, and concerns from treating physicians regarding their ability to provide appropriate care for children with obesity. Using data from the National Institute of Child Health and Human Development-funded Pediatric Trials Network (PTN), we explore possible ways to improve drug labeling in children with obesity. In order to improve health outcomes of children with obesity, carefully designed and executed PK trials and comprehensive PK analysis strategies are needed. Early collaboration with the Food and Drug Administration may be helpful in developing studies and analyses that are most beneficial for child health. This collaboration is particularly important for drugs that treat potentially life-threatening diseases, where inclusion of PK and dosing on the drug label is vital. We hope that increasing the body of knowledge on drug dosing in children with obesity will open the door to regulatory guidance based on extrapolation or population-specific PK studies, similar to other currently-recognized special populations. Given the magnitude of the pediatric obesity pandemic, recognition as a special population will offer substantial public health value.</p>","PeriodicalId":74429,"journal":{"name":"Pharmaceutical regulatory affairs : open access","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10201954/pdf/nihms-1842584.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10290192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

AMPK Activators as a Drug for Diabetes, Cancer and Cardiovascular Disease. 作为治疗糖尿病、癌症和心血管疾病药物的 AMPK 激活剂

Pharmaceutical regulatory affairs : open access Pub Date : 2014-07-01 Epub Date: 2014-04-03 DOI: 10.4172/2167-7689.1000118

Mark Goodman, Zhenling Liu, Ping Zhu, Ji Li

引用次数: 0

Therapeutic Opportunities through the Modulation of Endocannabinoid Transport. 通过调节内源性大麻素转运的治疗机会。

Pharmaceutical regulatory affairs : open access Pub Date : 2013-01-01 DOI: 10.4172/2167-7689.1000e123

Jason J Guo, Mark K Williams, Alexandros Makriyannis

引用次数: 2