Applications of drug interaction study in new drug development and regulartory decision-making / 中国临床药理学与治疗学

Drug-drug interactions (DDI) change dose-response relationships, and may result in low efficacy or high toxicity, which are important considerations especially in medical practice with multiple-drug therapies. Predicting clinically significant drug interactions during new drug development is an important part of benefit and risk assessment in drug development and review. This article summarizes the purpose and significance of drug interactions in new drug development, the main content and precautions of DDI studies in vivo and in vitro. Drug interaction studies on novel drug approvals for 2020 in the National Medical Products Administration (NMPA) and US Food and Drug Administration (USFDA) are examined, respectively. It aims to provide reference for DDI studies and regulatory reviews in new drug development in our country.

Tools and processes for tracking IRB approvals as a coordinating center for large multicenter clinical research networks

RTI International, San Francisco, CA, USA

RTI International, Research Triangle Park, NC, USA

RTI International, Rockville, MD, USADepartment of Oncology, King Abdul Aziz Medical City for National Guard, Riyadh, Saudi Arabia

Ulm University –Faculty of Medicine, Ulm, Germany

University of ThePeople, Pasadena, CaliforniaDepartment of Anaesthesia, Konaseema Institute of Medical Science, Amalapuram, Andhra Pradesh, India

Department of Pharmacology, Konaseema Institute of Medical Science, Amalapuram, Andhra Pradesh, IndiaDiscipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia

Physiotherapy Department, College of Applied Medical Science, Taif University, Taif, Saudi Arabia

Charles Perkins Centre, Prevention Research Collaborati on, School of Public Health, The University of Sydney, Sydney, Australia

School of Public Health, The University of Sydney, Sydney, Australia

An introspection of quality of novel drug approvals by United States Food and Drug Administration

Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for protection of the public health by assuring that foods are safe, wholesome, sanitary and properly labelled. Approved Novel drugs are often innovative products that serve unmet medical needs or otherwise help to advance patient care.Methods: FDA novel drug approvals were analysed from calendar year (CY) 2012 to 2016 on the basis of three criteria i.e., impact, access and predictability. Impact measured on the basis of: percentage of novel drug approvals (a) first in class (b) for rare diseases. Access measured on the basis of: percentage of novel drug approvals (a) first cycle approval (b) approval in the U.S. before other countries and (c) percentage of priority reviews. Predictability measured by: the percentage of novel drug approvals that met the PDUFA goal dates for the application review.Results: Total number of novel drugs approved from CY 2012 to 2016 was 176 (average 35 novel drugs/ year). Impact of novel drug approvals: 40% were first in class and 39% were for rare diseases. Access of novel drug approvals: 84% were first cycle approval, 60% were approval in US before other countries, 51% priority reviews among novel drug approvals. Predictability of novel drug approvals: 97% approvals able to meet PDUFA goal dates for application review.Conclusions: Novel drug approvals during CY 2012-2016 had a high quality which is very much evident by their high impact, good access and high predictability.

Review of new medical devices approvals by USFDA during the period of 2010 to 2014

Medical devices are health care products distinguished from drugs for regulatory purposes in most countries based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect. Developing new medical devices requires clinical investigations and approval process goes through similar process like drugs. Medical device approvals in the period of 2010 to 2014 were searched from USFDA website. Diseaseburden data in the similar period was searched from centers for disease control and prevention website. Collected data was analyzed to know number of approved devices, top therapy areas, and mechanism of action of these devices. Out of a total of 200 medical devices approvals in the time period of 2010 to 2014,maximum number of devices (51; 25.5%) were approved in the year 2011, cardiovascular (78; 39%) was the top therapy area. Highest number (180; 90%) of approved medical devices belonged to the category III and maximum number (73; 36.5%) of approved medical devices had ?mechanical? mechanism of action. The top 3 causes of deaths in USA during 2010 to 2014 were heart disease, cancer and followed by respiratory infection. There was a match between the topdiseases and the medical device approvals for top 2 diseases in USA i.e. heart disease, and cancer. With respect to respiratory infections and ailments which was the 3rd leading cause of death only one device was approved out of 200 approvals in total.

Robotic Cholecystectomy Using the Newly Developed Korean Robotic Surgical System, Revo-i: A Preclinical Experiment in a Porcine Model

One Korean company recently successfully produced a robotic surgical system prototype called Revo-i (MSR-5000). We, therefore, conducted a preclinical study for robotic cholecystectomy using Revo-i, and this is a report of the first case of robotic cholecystectomy performed using the Revo-i system in a preclinical porcine model. Revo-i consists of a surgeon console (MSRC-5000), operation cart (MSRO-5000) and vision cart (MSRV-5000), and a 40 kg-healthy female porcine was prepared for robotic cholecystectomy with general anesthesia. The primary end point was the safe completion of these procedures using Revo-i: The total operation time was 88 minutes. The dissection time was defined as the time from the initial dissection of the Calot area to the time to complete gallbladder detachment from the liver bed: The dissection time required 14 minutes. The surgical console time was 45 minutes. There was no gallbladder perforation or significant bleeding noted during the procedure. The porcine survived for two weeks postoperatively without any complications. Like the da Vinci surgical system, the Revo-i provides a three-dimensional operative view and allows for angulated instrument motion (forceps, needle-holders, clip-appliers, scissors, bipolar energy, and hook monopolar energy), facilitating an effective laparoscopic procedure. Our experience suggests that robotic cholecystectomy can be safely completed in a porcine model using Revo-i.

Characteristics of New Drugs as Ligands of G-Protein Coupled Receptor and Time-Dependent Changes of the New Drug Approvals over Three Decades from 1980 to 2009 in Japan / 医薬品情報学

<b>Objective: </b>We analyzed the characteristics of ligands of G-protein coupled receptor (GPCR) of new drugs approved, and the time dependent changes of these new drug approvals over three decades from 1980 to 2009 in Japan.<br><b>Methods: </b>The receptor therapeutic targets of 185 new drugs were distributed 20 receptor families of GPCR.  Most of new drugs which targeted GPCR were the ligands of class A receptors.  Among the class A receptors, the receptors of amine family, such as adrenaline, dopamine, histamine, serotonin and muscarinic receptor were the targets of new drugs.  One hundred and ten of 185 new drugs were the antagonist and other 75 were the agonist of GPCR.  Whether the new drug is agonist or antagonist depended on the receptor subtype.  The time dependent changes of new drug approval were different among the drugs depending on which GPCR was targeted.  Approval of new drugs which targeted some GPCR decreased time dependently.  In contrast, approval of new drugs which targeted other GPCR increased time dependently or continuously retained.<br><b>Results: </b>The results obtained in this study indicated characteristics of targeted GPCR, and time dependent changes of new drugs approvals, and suggest the future aspect of new drugs.