Drug discovery strategies for acute radiation syndrome

Introduction: There are at the minimum two major, quite different approaches to advance drug discovery. The first being the target-based drug discovery (TBDD) approach that is commonly referred to as the molecular approach. The second approach is the phenotype-based drug discovery (PBDD), also known as physiology-based drug discovery or empirical approach.

Area covered: The authors discuss, herein, the need for developing radiation countermeasure agents for various sub-syndromes of acute radiation syndromes (ARS) following TBDD and PBDD approaches. With time and continuous advances in radiation countermeasure drug development research, the expectation is to have multiple radiation countermeasure agents for each sub-syndrome made available to radiation exposed victims.

Expert opinion: The majority of the countermeasures currently being developed for ARS employ the PBDD approach, while the TBDD approach is clearly under-utilized. In the future, an improved drug development strategy might be a ‘hybrid’ strategy that is more reliant on TBDD for the initial drug discovery via large-scale screening of potential candidate agents, while utilizing PBDD for secondary screening of those candidates, followed by tertiary analytics phase in order to pinpoint efficacious candidates that target the specific sub-syndromes of ARS.     

Scale-up of Adhesive Transdermal Drug Delivery Systems

Pharmaceutical Research -     

药品补充申请审批状况初探

本文通过分析1999-2002年药品补充申请数量大量增加及审批速度减缓的原因，结合目前药品补充申请审批方式，提出加快审批速度的一些方法和建议。     

上海地区新药研发现状及新药注册资料中存在问题分析

本文分析了上海地区新药研发状况 ,并对所报新药审评过程进行了追踪 ,对新药申报资料中的不足作了汇总分析 ,并着重指出了新药申报资料中存在的问题和新药审批结果带给大家的启示。     

2014年上半年美国FDA批准药物简介

2014年上半年美国FDA批准46种新药（包括修改说明书,新剂型,新组方和其他）,其中首次批准上市10个新分子实体和生物制品许可申请10个,共计20个。本文根据FDA批准的处方资料的要点,简要介绍新药概况、作用机制、适应证、剂量和用法、黑框警告、禁忌证、不良反应、药物相互作用及特殊人群中使用要点。并讨论了2014上半年批准新药在药物开发、研究和审评使中的首次事件。     

美国医疗器械管理与临床研究现状

在美国,医疗器械的临床研究是建立在医疗器械分类管理的基础之上,是一部分医疗器械在上市前必须经过的步骤之一,也是保证医疗器械安全性和有效性的方法之一。临床试验的进行必须遵守器械临床试验豁免(investigational device exemption,IDE)的规定,以良好控制的临床试验为基础,以完整准确的数据分析为结论。     

2019年美国FDA批准上市的新药简介

2019年美国食品药品监督管理局(FDA)批准上市新药48个,其中化学小分子38个、生物制品10个。本文根据FDA批准的新药说明书以及相关文献和专利情况,简要介绍化学小分子药物的概况、适应证、作用机制、剂型规格、不良反应和合成路线等,以及生物制品的相关情况。     

Adverse drug and device reactions in the oral cavity: Surveillance and reporting

BackgroundAccording to the U.S. Centers for Disease Control and Prevention, 48 percent of Americans (roughly 144 million people) used at least one prescribed medication in the preceding month; 11 percent used five or more. The authors describe the U.S. Food and Drug Administration's (FDA's) MedWatch program, the safety surveillance system for drugs and devices in the United States, and the dentist's role with regard to voluntary reporting of adverse effects (AEs). They also identify the most frequent AEs in the oral cavity as reported in the FDA Adverse Event Reporting System (FAERS).MethodsThe authors reviewed the literature regarding MedWatch, and they mined data in the FAERS public database for the 100 most commonly prescribed medications and their associated AEs.ResultsPharyngitis was the most common AE. Cough, dysgeusia and dysphagia also were common.ConclusionThe MedWatch program and its related databases contain useful information about AEs of pharmaceuticals and devices manifested in the oral cavity. Increased participation in the reporting of suspected adverse reactions will improve the national surveillance system and ultimately will protect patients' safety.Practical ImplicationsAs pharmaceutical consumption increases exponentially for a growing segment of the population, and as innovation in dental technology and devices flourishes, dentists have a distinct role in safeguarding patients' well-being. Promptly reporting AEs in the oral cavity improves quality of care and protects patients' well-being.