Clinical Research and Regulatory Affairs最新文献_第3页

Considerations for clinical trial design with obesity-related devices 使用肥胖相关装置进行临床试验设计的考虑

Clinical Research and Regulatory Affairs Pub Date : 2015-01-02 DOI: 10.3109/10601333.2015.983647

Herbert Lerner, Martha W. Betz

引用次数: 1

Issues in regulating E-cigarette clinical research 规范电子烟临床研究的问题

Clinical Research and Regulatory Affairs Pub Date : 2015-01-02 DOI: 10.3109/10601333.2014.976230

C. Bullen, O. Knight-West

{"title":"Issues in regulating E-cigarette clinical research","authors":"C. Bullen, O. Knight-West","doi":"10.3109/10601333.2014.976230","DOIUrl":"https://doi.org/10.3109/10601333.2014.976230","url":null,"abstract":"Abstract E-cigarettes have become popular in many countries, despite a lack of long-term safety data and limited clinical evidence for a role in smoking cessation. Indeed, in England, they have overtaken nicotine replacement therapy as a preferred product for cessation support. However, e-cigarettes have reached the market without evaluation of cessation efficacy and safety, bypassing the route required by regulatory authorities for pharmaceuticals that make therapeutic claims. Adequately powered clinical trials that evaluate the cessation efficacy potential of these products compared with current cessation treatments are needed; although the novel features and challenges of assessing this product group, such as wide diversity, rapid evolution and range of user behaviors, do not fit well within the standard clinical trial framework. This should be taken into account by regulators. Alternative designs that are pragmatic, accommodate user preferences, and include smoking reduction end-points may also be required. A more consistent approach to the regulation of products that deliver nicotine—one that does not favor tobacco—should be considered as part of a comprehensive nicotine regulatory model.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82297394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 2

Bioequivalence studies in Europe before and after 2010 2010年前后欧洲生物等效性研究

Clinical Research and Regulatory Affairs Pub Date : 2015-01-02 DOI: 10.3109/10601333.2014.976229

C. Daousani, V. Karalis

{"title":"Bioequivalence studies in Europe before and after 2010","authors":"C. Daousani, V. Karalis","doi":"10.3109/10601333.2014.976229","DOIUrl":"https://doi.org/10.3109/10601333.2014.976229","url":null,"abstract":"Abstract Regulatory guidelines are necessary to standardize the evaluation procedure in bioequivalence. Revisions in the guidelines occur in order to resolve any previously unclear issues and to address new needs. In this paper, the authors discuss the major regulatory requirements for bioequivalence assessment before and after the EMA guidelines of 2010 and unveil their differences. The authors compiled this review following the critical exploration of literature articles and regulatory guidance documents. This was achieved through searching MEDLINE, Scopus, and the official EMA site. The authors found, in the post-2010 era, that the major differences in the regulatory framework refer to: the choice of clinical designs, the assessment of highly variable drugs, biowaivers, the pharmacokinetics parameters used, and the explicit definition for the use of metabolite data, enantiomers, and endogenous substances. Also, product-specific guidelines have started to be issued, while recommendations are now provided for some special formulations like orodispersible tablets. Other issues were elucidated like studies in the fasting or fed state and the dissolution assessment. The EMA regulatory framework on bioequivalence changed significantly in the post-2010 era. Many issues are now defined more explicitly, while others are newly introduced. However, some issues remain unresolved.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86607257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Special population considerations and regulatory affairs for clinical research. 特殊人群考虑因素和临床研究监管事务。

Clinical Research and Regulatory Affairs Pub Date : 2015-01-01 DOI: 10.3109/10601333.2015.1001900

Kristin N Grimsrud, Catherine M T Sherwin, Jonathan E Constance, Casey Tak, Athena F Zuppa, Michael G Spigarelli, Nicole L Mihalopoulos

{"title":"Special population considerations and regulatory affairs for clinical research.","authors":"Kristin N Grimsrud, Catherine M T Sherwin, Jonathan E Constance, Casey Tak, Athena F Zuppa, Michael G Spigarelli, Nicole L Mihalopoulos","doi":"10.3109/10601333.2015.1001900","DOIUrl":"10.3109/10601333.2015.1001900","url":null,"abstract":"<p><p>Special populations, including women (non-pregnant and pregnant), pediatrics, and the elderly, require additional consideration with regard to clinical research. There are very specific regulatory laws, which protect these special populations, that need to be understood and adhered to in order to perform clinical research. This review provides a broad overview of some of the physiological differences in special populations and discusses how these differences may affect study design and regulatory considerations. These various special populations, with respect to regulatory affairs, are clearly defined within the Code of Federal Regulations. The definition of \"special population\" exists to provide enhanced awareness of their vulnerabilities, thereby allowing the creation of regulatory guidance aimed to decrease injury or outright harm. Currently, progress is being made to be more inclusive of special populations in clinical trials. This reflects changing attitudes towards drug information, with it being more representative of those patients that will ultimately be prescribed or exposed to the therapy. However, all research undertaken in these populations should be performed in a manner that ensures all protections of each participant are upheld.</p>","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4577021/pdf/nihms706688.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34199842","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

Current regulatory systems for clinical trials in Japan: Still room for improvement 日本临床试验的现行监管制度:仍有改进的余地

Clinical Research and Regulatory Affairs Pub Date : 2014-06-01 DOI: 10.3109/10601333.2014.956932

H. Yanagawa

{"title":"Current regulatory systems for clinical trials in Japan: Still room for improvement","authors":"H. Yanagawa","doi":"10.3109/10601333.2014.956932","DOIUrl":"https://doi.org/10.3109/10601333.2014.956932","url":null,"abstract":"Abstract A main characteristic of the regulatory environment for clinical trials in Japan is that governmental regulations only apply to trials required for the approval of drugs or medical devices. Investigator-initiated clinical trials outside this registration scheme, such as large-scale trials to establish evidence for already approved drugs, are conducted based on government guidelines without corresponding laws. The Japanese adoption of Good Clinical Practice in 1997 and the governmental clinical trials vitalization plans instituted in 2003 have led to the improvement of infrastructure for registration trials, and this has in turn improved registration trial speed and quality. Global trials, rather than strictly domestic trials, are now prevailing. In contrast, problems associated with investigator-initiated trials conducted outside registration trial requirements were recently exposed by a scandal concerning a study of the anti-hypertensive drug valsartan. After the drug was launched, secondary benefits were reported in several academia-initiated clinical trials; these results proved to be fraudulent and the articles were retracted. This scandal threatens the reputation of Japanese drug trials and highlights the lack of scrutiny such trials have in terms of the potential conflicts of interest. To combat this issue, Japan has begun to establish new guidelines and a regulatory infrastructure to enhance the reliability of investigator-initiated clinical trials.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2014-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75325792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 6

Comparison of EMA and FDA guidelines for drug interactions: An overview EMA和FDA药物相互作用指南的比较:概述

Clinical Research and Regulatory Affairs Pub Date : 2014-06-01 DOI: 10.3109/10601333.2014.957311

S. Janković

{"title":"Comparison of EMA and FDA guidelines for drug interactions: An overview","authors":"S. Janković","doi":"10.3109/10601333.2014.957311","DOIUrl":"https://doi.org/10.3109/10601333.2014.957311","url":null,"abstract":"Abstract In 2013, the regulatory authorities of the European Union and the US issued, almost simultaneously, new editions of the industry guidelines for the requirements of drug testing during their development for drug–drug and drug–food interactions. That being said, there are significant differences in the requirements set by both guidelines, and the aim of this article is to point out those differences. In this review, the author carefully and comprehensively compared the publicly available guidelines via the official Food and Drug Administation’s (FDA) and European Medicine Agency’s (EMA) websites, highlighting the differences between the two sets. Unlike the guidelines provided by the FDA, the EMA guidelines lack set requirements for testing interactions with therapeutic proteins as well as with the usage of pharmacodynamics end-points. It also does not set standards for the use of the ‘no interaction’ declaration in the summary of product characteristics. On the other hand, the FDA currently lacks guidance for testing drug–food interactions, the use of the Relative Induction Score correlation method, and proving existence of reversible inhibition and mechanism-based inactivation. It is important to note that, while there are differences in the requirements for the FDA’s and the EMA’s drug interaction guidelines, they are not substantial and are mostly relating to the scope of requirements and precision of the standards set.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2014-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76687713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 2

Assessment of internet gaming disorder in clinical research: Past and present perspectives 网络游戏障碍在临床研究中的评估:过去和现在的观点

Clinical Research and Regulatory Affairs Pub Date : 2014-06-01 DOI: 10.3109/10601333.2014.962748

H. Pontes, M. Griffiths

{"title":"Assessment of internet gaming disorder in clinical research: Past and present perspectives","authors":"H. Pontes, M. Griffiths","doi":"10.3109/10601333.2014.962748","DOIUrl":"https://doi.org/10.3109/10601333.2014.962748","url":null,"abstract":"Abstract Internet Gaming Disorder (IGD) has recently received nomenclatural recognition from official medical bodies as a potential mental health disorder, despite evident variability and inconsistencies in its core conceptualization and psychometric assessment. Research on gaming addiction dates back to the 1970s, and important changes in the field have occurred, especially in terms of definition and conceptualization of the phenomenon, which resulted in a multiplicity of strategies in the assessment of IGD via inconsistent criteria or psychometric tools. In the present review, the authors argue how the adoption of inconsistent criteria and psychometric tools for assessing IGD has negatively influenced the field. Furthermore, this review provides an overview of how the field evolved in terms of its historical developments, current definitions and frameworks, developments in the neurobiological research, psychometric assessment, and emerging trends in the assessment of gaming addiction. Finally, the paper provides information on alternative emerging methods for assessing IGD via sound psychometric tools based on updated and officially recognized conceptualization of the phenomenon of IGD.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2014-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74299078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 84

A newer dimension to regulation of ethics committees in India 印度伦理委员会监管的新层面

Clinical Research and Regulatory Affairs Pub Date : 2014-02-21 DOI: 10.3109/10601333.2013.842576

Ila Narang, Ishita Kumari Bharota, S. Raisuddin, Gaurav Kumar Jain, Nidhi Bharal Agarwal

{"title":"A newer dimension to regulation of ethics committees in India","authors":"Ila Narang, Ishita Kumari Bharota, S. Raisuddin, Gaurav Kumar Jain, Nidhi Bharal Agarwal","doi":"10.3109/10601333.2013.842576","DOIUrl":"https://doi.org/10.3109/10601333.2013.842576","url":null,"abstract":"Abstract Clinical research is a pre-requisite part of the drug discovery and development process, with the main aim to ensure the safety and efficacy of any new drug. In today’s date, clinical trials are the backbone for bringing newer and better drugs to market. Although a set of established guidelines are available for governing the conduct of clinical trials in India, the ethics committees of this country are still struggling with basic issues viz, inadequate or no standard operating procedures (SOPs) and non-compliance with the Schedule Y recommendations. The ethics committee being the prime body with the responsibility of regulating clinical research, protecting and safeguarding the rights, safety and well-being of research participants, the institutions, hospitals, and pharmaceutical industries that focus on enhancing their research facilities tend to ignore the various aspects of ethics committees like composition and qualification of members forming the quorum, regular updates of ethics committees to be reported to the central authority, lack of administrative support and communication, inadequate remuneration offered to members serving to ethics committee boards, archival of records and regular auditing of the ethics committee. The central regulatory body of India CDSCO governing the conduct of clinical trial, in October 2012, under the guidance of Drugs Technical Advisory Board, laid down three major amendments in schedule Y. The present article discusses one of the new amendments laid down recently in schedule Y under rule 122 DD which states the requirements and guidelines needed for registration of ethics committees in India.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2014-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80072168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Development and validation of a LC-ESI-MS/MS method for simultaneous quantification of olmesartan and hydrochlothiazide in human K3 EDTA plasma and its application to pharmacokinetic biostudy LC-ESI-MS/MS同时定量人K3 EDTA血浆中奥美沙坦和氢氯噻嗪的方法建立与验证及其在药代动力学生物学研究中的应用

Clinical Research and Regulatory Affairs Pub Date : 2014-02-21 DOI: 10.3109/10601333.2013.849267

Ajay Kumar, Priya Ranjan Prasad Verma, T. Monif, A. Khuroo, S. Iyer

{"title":"Development and validation of a LC-ESI-MS/MS method for simultaneous quantification of olmesartan and hydrochlothiazide in human K3 EDTA plasma and its application to pharmacokinetic biostudy","authors":"Ajay Kumar, Priya Ranjan Prasad Verma, T. Monif, A. Khuroo, S. Iyer","doi":"10.3109/10601333.2013.849267","DOIUrl":"https://doi.org/10.3109/10601333.2013.849267","url":null,"abstract":"Abstract This is the first publication on a complete validated bioanalytical method for estimation of olmesartan (OLM) and hydrochlorothiazide (HCTZ) in human K3 EDTA plasma that chromatographically resolves its olmesartan glucuronide. An API 4000 mass spectrometer was employed in this method where olmesartan d4 (OLMD4) and hydrochlorothiazide −13C, d2 (HCTZD2) served as the internal standard. Sample was prepared by solid phase extraction (SPE) technique using a polymer based, MCX cartridges and chromatographic resolution achieved on Synergi MAX RP-18A, (4.6 × 150 mm, 4 μm) column using a mobile phase of 0.2% formic acid solution/acetonitrile (30:70, v/v). Negative mass transitions (m/z) of OLM, HCTZ, OLMD4, and HCTZD2 were detected in multiple reactions monitoring (MRM) mode at 445.5 → 149.3, 296.0 → 269.0, 449.2 → 149.3, and 299.1→270.0, respectively. The linearity was checked over a concentration range of 4.051–2500.912 ng/mL for OLM and 0.506–304.109 ng/mL for HCTZ. Intra- and inter-run precision of OLM and HCTZ assay at four concentration levels were below 3.7% and 4.3%, and accuracy was within ±4.4% and 3.0%, respectively. Mean recoveries for OLM, HCTZ, and internal standards OLMD4 and HCTZD2 were 75.68, 77.60%, and 80.2, 89.1%, respectively. This method has been successfully applied to pharmacokinetic biostudy.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2014-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76778857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 6

Reducing the average number of patients needed in a phase II trial through novel design 通过新颖的设计减少II期试验所需的平均患者数量

Clinical Research and Regulatory Affairs Pub Date : 2013-11-27 DOI: 10.3109/10601333.2013.854802

J. Wason

引用次数: 3