Clinical Research and Regulatory Affairs最新文献

{"title":"Retracted: Prescription to over-the-counter movement and its regulations","authors":"S. Dubey, R. D. Ukawala, D. Jha","doi":"10.3109/10601333.2012.706613","DOIUrl":"https://doi.org/10.3109/10601333.2012.706613","url":null,"abstract":"RETRACTED","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76706908","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}

{"title":"Pharmacovigilance regulations in India: A Step forward","authors":"Shilpi Khattri, V. Balamuralidhara, K. Pramod, Ravi Valluru, M. Venkatesh","doi":"10.3109/10601333.2012.692688","DOIUrl":"https://doi.org/10.3109/10601333.2012.692688","url":null,"abstract":"Robust regulatory arrangements provide the foundation for a national method of medicine safety, and for public confidence in medicines. This article focuses on the need to sharpen the regulatory requirements for pharmacovigilance in India. To be effective the remit of drug regulatory authorities needs to go further than the approval of new medicines, to encompass a wider range of issues related to the safety of medicines. In order to achieve their respective objectives pharmacovigilance programs and drug regulatory authorities must be mutually supporting. On one hand, pharmacovigilance programs need to maintain strong links with the drug regulatory authorities to ensure that the latter are well briefed on safety issues in everyday clinical practice, whether these issues are relevant to future regulatory action or concerns that emerge in the public domain. On the other, regulators need to understand the pivotal role that pharmacovigilance plays in ensuring the ongoing safety of medicinal products. Despite global focus on the Development Safety Update Report, Indian regulators are not yet insistent on real-time update of a drug’s cumulative safety profile. Hence, the present article concludes with a strong urge to postulate regulations that create a comprehensive medicine safety system through careful strategic planning that envelope all aspects of pharmacovigilance.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2012-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74765935","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}

{"title":"Determination of pharmacokinetics of itraconazole in healthy Indian subjects under fed condition and incurred sample analysis using a validated liquid chromatography tandem mass spectrometric method","authors":"A. Patni, T. Monif, A. Khuroo, S. Iyer, Rakesh K. Jain, Sudershan Kumar, A. Tiwary","doi":"10.3109/10601333.2012.668192","DOIUrl":"https://doi.org/10.3109/10601333.2012.668192","url":null,"abstract":"This study aimed to determine Itraconazole Pharmacokinetics in healthy Indian subjects under fed condition and incurred sample analysis in human plasma by using a validated liquid chromatography tandem mass spectrometric method. A study in healthy human Indian subjects under fed condition was conducted to determine pharmacokinetics of two treatments of Itraconazole 100 mg capsules. Method validation was performed as per USFDA guidelines. Incurred Sample Reanalysis (ISR) was performed by random selection of subject samples. All the method validation parameters were found to be acceptable in terms of accuracy and precision. Results of all stability exercises in human plasma were within acceptable limits. The validated LCMS/MS method was used for sample analysis. A value of 96.7% for Itraconazole and 92.2% for Hydroxy Itraconazole was observed for incurred sample re-analysis. Arithmetic means for Cmax and AUC0→∞ were 103.699, 95.105 ng/ml and 1665.599, 1556.486 ng/ml.h, respectively, for Itraconazole and for Hydroxy itraconazole Cmax and AUC0→∞ were 179.436, 173.037 ng/ml and 4136.456, 4049.746 ng/ml.h, respectively, in treatment 1 and 2. In conclusion, a LCMS/MS method for quantification of Itraconazole and Hydroxy Itraconazole was used for analysis of clinical samples and determination of pharmacokinetic of Itraconazole in a fed study in an Indian population. Incurred sample re-analysis data indicate good acceptance and reproducibility of the method.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2012-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76346076","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}

{"title":"Laboratory information and management system: A tool to increase laboratory productivity","authors":"S. Dubey, A. Anand, Hemanth Jangala","doi":"10.3109/10601333.2012.692689","DOIUrl":"https://doi.org/10.3109/10601333.2012.692689","url":null,"abstract":"‘Information is a crucial capital asset of any business and its commercial prospect is directly related to successful management of its information resources’. Laboratory Information Management System (LIMS) is software that is designed to administer samples, acquire and manipulate data, and report results via a database. It automates the process of sampling, analysis, and reporting. This paper discusses components, sample workflow, application, and validation of LIMS. The contents of this paper are easy to understand. The objective of this paper is to discuss how LIMS works and its application, and to discuss a potential approach to validation of the LIMS. A literature search was conducted in various journals. Based on title and abstract, 30 papers were identified. Extraction of useful information was done after thorough study of selected papers. Components of LIMS, how it works, its application, and potential approach of validation of LIMS was compiled in an easy-to-understand way. In conclusion, LIMS is a critical component of successful commercial laboratory in quality control, process control, and R&D environment.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2012-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82977765","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}

{"title":"Understanding the reality: Is India losing standing for clinical research?","authors":"S. Parekh, S. Shewale","doi":"10.3109/10601333.2011.653570","DOIUrl":"https://doi.org/10.3109/10601333.2011.653570","url":null,"abstract":"In recent years, the growth of clinical research has gone up globally, and countries from Asia are gaining in importance. Being the preferred hub for clinical research because of its young, highly educated work-force, prevalence of all major diseases, and, most importantly, use of English as the medium of communication and documentation making, India is an attractive destination. While enduring growth; few countries have made substantial changes to align with the international standards, wherein the state of affair is still in the process of improvement in India. Also, because of the ever growing hurdles for conducting trials in India, many clinical research sponsors have started searching for other suitable alternatives. Seemingly minor details could have a great impact on the outcome of the trial, not just in terms of time and money, but also the quality and credibility of the data generated. While there are a lot of similarities with that of Western standards of clinical research, there are indeed some key differences as well. Thus, India needs to take the next step up the value ladder to magnetize the global clinical research to outsource, drug discovery and development projects to India, to accelerate timelines and manage complexity. This article attends to various pieces of the same puzzle.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80528859","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}

{"title":"The opportunities and challenges in conducting clinical trials globally","authors":"Navneeta Bansal","doi":"10.3109/10601333.2011.647034","DOIUrl":"https://doi.org/10.3109/10601333.2011.647034","url":null,"abstract":"Clinical trials using human subjects are an integral part of the approval of new drugs and biologics. According to Center Watch, 86% of US clinical studies fail to recruit the required number of subjects on time. It is therefore logical that pharmaceutical companies would turn to global outsourcing. Many of these trials are being conducted in developing countries. Accrual in developing countries can be 5–10-times quicker than in the US or Europe. However, clinical trials conducted in other countries differ in many respects. Thus, conducting clinical trials globally raises the concerns of regulatory authorities regarding the transparency, quality, accuracy, and carrying out of these trials following ethical norms. Although clinical research abroad is greatly facilitated by recent efforts to standardize regulatory procedures, and using new technologies has helped to standardize multinational data collection, the issues associated with the globalization of clinical trials still raises concerns about the ethics, adequacy of regulatory supervision of clinical trial, and accuracy and validity of results. This paper examines the impact of the trend being followed globally and presents an analysis of potential ways to capitalize on the associated opportunities while mitigating the challenges in conducting clinical trials globally.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80378871","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}

{"title":"Bioanalytical method development and validation using incurred samples: Quantitative estimation of metformin in human K3EDTA plasma by LC–MS/MS","authors":"S. Gurule, D. Goswami, A. Saha, Yogesh Modhave, A. Khuroo, T. Monif","doi":"10.3109/10601333.2012.661931","DOIUrl":"https://doi.org/10.3109/10601333.2012.661931","url":null,"abstract":"Bioanalytical methods should be reproducible and consistent when applying to clinical sample analysis. Incurred sample reanalyses (confirmatory reanalyses) are performed to support clinical data, and regulatory agencies evaluate the same before approval of bioequivalent products/drugs. A confirmatory reanalysis was demonstrated for metformin after administration of 2/500 mg repaglinide + metformin fixed dose formulation under fasted and fed conditions. The liquid chromatography tandem mass spectrometry (LC-MS/MS) method for determination of metformin in human plasma using metformin-d6as an internal standard has been developed and validated. The ions transitions recorded in multiple reaction monitoring (MRM) were m/z 130.1→60.0 and 136.2→60.0 for metformin and metformin-d6, respectively. The compounds were isolated by solid phase extraction and separated on a C12 reverse phase (Synergi MAX-RP 80A) column, using isocratic mobile phase flow at a flow rate of 0.8 mL/min. No matrix effect was observed within the linearity range of 10.2–1741.8 ng/mL (r2 > 0.99). The acceptable result of confirmatory reanalysis further indicated stability of metformin in the presence of repaglinide. The assay method was found to be highly reproducible and was successfully applied for pharmacokinetic evaluations of metformin in fixed dose combinations with repaglinide.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88670807","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}

{"title":"Obituary for Sanford Weinberg (1950–2011)","authors":"","doi":"10.3109/10601333.2011.640521","DOIUrl":"https://doi.org/10.3109/10601333.2011.640521","url":null,"abstract":"","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89051685","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}

{"title":"Renovation of the new medicine regulatory process","authors":"S. Crooke","doi":"10.3109/10601333.2011.607462","DOIUrl":"https://doi.org/10.3109/10601333.2011.607462","url":null,"abstract":"As we near the end of the first decade of the 21st century, it is obvious that the discovery, development, and commercialization of new medicines is a dynamic process that has become vastly more complicated than it was even a few years ago. It is an international process involving companies located in many different countries, clinical trials performed in even more countries and academic contributions from around the world. There are many hundreds of drugs in clinical development. They are representatives of multiple technologies and chemical classes including small molecules, monoclonal antibodies, other proteins, anti-sense oligonucleotides, aptamers, and gene therapy, and, perhaps in the near future, stem cell-based therapeutics. These clinical trials are sponsored by very large multinational pharmaceutical and biotechnology companies with very substantial experience, generic companies, traditional regional companies expanding toward worldwide markets, and biotechnology companies that range in size and competency from very large and experienced to virtual with virtually no experience. The trials are, in fact, often conducted by contract research organizations that again vary widely in size, competency, and experience. All of this is managed by a very uneasy collaboration between the industry, academic medicine, and regulatory agencies. Expectations for the development of new medicines have changed substantially as well. There is greater focus on demonstrating long-term safety. Efficacy trials have become much larger, more complicated and even more multinational. Further, in many therapeutic areas there is increasing demand for long-term outcome studies. These factors contribute to progressively costlier and more time-consuming development cycles that are coupled to longer regulatory review processes, more rapid emergence of competitive products and shorter effective patent lives. These factors, in turn, put more pressure on companies to extract the maximum in sales and profits as rapidly as possible after commercialization, resulting in even greater reliance on direct-to-consumer advertising and efforts to encourage as broad a use of the new medicines as possible. Contemporaneously, food and food processing, nutritionals, vitamins and supplements, cosmetics, and diagnostic industries have also become much more complex. In response, the FDA has grown. It has promulgated new rules and guidelines in virtually every area. It has imposed user fees on the industries it regulates and is buffeted by conflicting demands to facilitate the development of new products, yet reduce risk to unachievable levels. The net result is that no one is satisfied. Patients and patient advocacy groups quite correctly complain about limited progress. The industries contend that the regulatory processes are intrusive, cumbersome, and are applied capriciously. The FDA is criticized consistently and it has been difficult for the agency to recruit and retain outstanding ind","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2011-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89768936","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}

{"title":"International regulatory review: Israel","authors":"S. Weinberg, Qiu Fang","doi":"10.3109/10601333.2011.627861","DOIUrl":"https://doi.org/10.3109/10601333.2011.627861","url":null,"abstract":"This paper is one of a series of country case studies reviewing nations’ regulatory body for the healthcare industry. It reports Israel’s modern regulatory environment and the social background that has shaped its unique agency structure and functionalities. With the Ministry of Health acting as a combination regulatory body, international trade negotiator, and industry supporter, Israel has established a complex partnership relation between government and industry without compromising the regulatory functions of the agency. The result is a focus on protecting Israeli citizen’s health and safety; expanding exports; and assuring the quality of pharmaceutical imports.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2011-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79386133","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}