Drug information journal : DIJ / Drug Information Association最新文献

{"title":"Editor’s Commentary","authors":"J. Turner","doi":"10.1177/0092861512465406","DOIUrl":"https://doi.org/10.1177/0092861512465406","url":null,"abstract":"","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123488764","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":"Review of IND Submissions: A Primer\u0000","authors":"E. Tabor","doi":"10.1177/0092861512462022","DOIUrl":"https://doi.org/10.1177/0092861512462022","url":null,"abstract":"The subtitle of this book is ‘‘An in-depth guide to writing, editing, tracking, and submitting the original IND and applicable IND amendments.’’ This book is a clear and thorough guide to the preparation, writing, publishing, submission, and monitoring of documents that FDA requires drug sponsors to submit. Although the title and subtitle focus on IND submissions, in fact the book covers in depth a few other types of FDA submissions as well, such as orphan drug applications and FDA meeting requests. The book is set up like a training manual for those who are entering regulatory affairs for drug products, and it is a good one. It would be useful as a textbook for a regulatory affairs course or to study for certification. Although it is very basic, it might also be useful as a desk reference for a regulatory affairs department for a quick look at an applicable chapter when a quick answer is needed. Topics include all aspects of INDs, including administrative aspects of submissions (creating style guides and templates; tips on writing and coordinating writing by a group; FDA forms), paper and electronic submissions, tracking submissions, managing references, CTD format, electronic document management systems, FDA meetings, dispute resolution, expanded use INDs, exploratory INDs, IND amendments, protocols, transfers of obligations, investigator’s brochures, safety reports, fast-track designation, responding to clinical holds, special protocol assessments, statistical analysis plans, filing at clinicaltrials.gov, CMC issues, orphan drug issues, USAN and proprietary name development, inactivating and reactiving an IND, and drug master files. The book does not seem to miss any IND-related topics, and everything I read was very accurate and also easy to read. The organization of the book is roughly along the lines of how one would go about initiating and maintaining an IND. However, surprisingly many introductory concepts are not introduced until chapters 22, 26, and 27. This is a sizable book, with 530 pages of relatively large dimensions (approximately 11’’ 12’’). It has a plastic spiral binding, but that is mounted within an attractive solid hardcover backing. The spiral binding appears intended to allow readers to remove the spiral-bound pages from the hard cover so that pages can be turned back on the spiral. Each of the 62 chapters is marked with a thick-tabbed divider with each topic clearly marked on the tab, which is extremely convenient and makes its use as a reference tool easier, particularly since the book lacks an index. Its 33-page detailed table of contents partially compensates for this as well. One of the most impressive aspects of this book is the accompanying CD-ROM, containing template documents, arranged by chapter, for 54 of the chapters. With artificial ‘‘samples’’ of FDA meeting requests, completed FDA forms, etc, as well as a sample style guide and examples of the types of letters that FDA sends to drug sponsors, this CD-ROM col","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"354 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116319021","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":"Associate Editor’s Commentary: In Praise of a BRAT","authors":"Peter J. Pitts","doi":"10.1177/0092861512463004","DOIUrl":"https://doi.org/10.1177/0092861512463004","url":null,"abstract":"The FDA is currently designing a 5-item grid as a management tool to explain its benefit-risk decisions in a more concise format. The grid comprises 5 basic factors that need to be addressed in any decision on the commercial availability of a drug. The top 2 factors are the seriousness of the condition addressed and the need for a new treatment of the condition. Then comes the traditional heart of the New Drug Application (NDA) package: analyses of clinical data on the benefits of the drug and the risks associated with its use. The fundamental factor is explicitly the level of risk management associated with the product. The FDA will be taking this into consideration in every decision; sponsors who ignore or underplay the identification of who should use the product and who might use it will have a gap in their filings. The grid proposal does not call for a fixed mathematical formula behind each approval since the agency has not tried to reduce the judgments in an approval decision to a rigid calculation. In the words of Dr John Jenkins, director of the Office of New Drugs at the Center for Drug Evaluation and Research, disagreement ‘‘happens a lot in the decisions that we have to make. Very few of the decisions that we make on drugs are easy. Very few of the drugs we see have a dramatic overwhelming benefit with relatively no risk. We see that most drugs have marginal to moderate benefits on a population basis and they have general safety but they have the risks of serious toxicities at some low levels.’’ In other words, every decision is very complex. Acknowledgment that decisions are not simple ‘‘black and white’’ ones is a good start here, but there’s a better way forward. A recent paper in Clinical Pharmacology & Therapeutics calls for the creation of a Benefit Risk Action Team (BRAT) framework, a set of processes and tools for selecting, organizing, summarizing, and interpreting data that is relevant to decisions based on benefit-risk assessments. The result of a 5-year effort by a team organized and facilitated by the Pharmaceutical Researcher and Manufacturers of America (PhRMA), the BRAT framework is a move toward an assessment that seeks to incorporate all relevant aspects of benefit and risk. The focus is on both qualitative and quantitative analysis. The current framework can incorporate weighting of outcomes but does not focus on calculation of overall benefit-risk scores. The authors argued that BRAT provides a standardized yet flexible platform for incorporating study outcomes and preference weights as well as for communicating the rationale for decisions. They commented as follows:","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126683310","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":"Clinical Trials: Rethinking How We Ensure Quality","authors":"M. Landray, C. Grandinetti, J. Kramer, Briggs W Morrison, Leslie Ball, R. Sherman","doi":"10.1177/0092861512464372","DOIUrl":"https://doi.org/10.1177/0092861512464372","url":null,"abstract":"This article is the version submitted to the publisher which was accepted without revision.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114164984","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":"DIA/NORD 2012 US Conference on Rare Diseases and Orphan Products: Poster Abstracts","authors":"S. Wilms, H. Etchevers, C. Brownstein, E. Dechene, M. Connolly, P. J. Park, S. Kong, K. Flannery, I. Kohane, D. Margulies, A. Beggs","doi":"10.1177/0092861512461897","DOIUrl":"https://doi.org/10.1177/0092861512461897","url":null,"abstract":"DIA/NORD 2012 US Conference on Rare Diseases and Orphan Products: Poster Abstracts The accepted Poster Abstracts for the DIA/NORD 2012 US Conference on Rare Diseases and Orphan Products: Shaping the Future Now are printed below. The posters present scientific developments related to research or studies on rare diseases or public health projects. The meeting was held October 22-24, 2012 in Washington, DC. Elucidating the Mechanism of the Allergic Inflammation in Eosinophilic Esophagitis Mari Kent, Ozlem Goker-Alpan, MD, and Oral Alpan, MD 1 Laboratory of Immunopathogenesis, O&O Alpan LLC, Fairfax, VA, USA 2 James Madison University, Harrisonburg, VA, USA 3 CFCT, O&O Alpan LLC, Fairfax, VA, USA Objective: The rationale for the study is to understand the role of IgE in eosinophilic esophagitis, a rare disorder. Method: Patients with eosinophilic esophagitis (EE) were treated with a drug (omalizumab) that blocks IgE in the body. This therapy is approved for asthma but had not been used in eosinophilic esophagitis. We obtained IRB and FDA approval to test this drug to understand disease mechanism in EE. Results: This study defines improvement in patient condition with 2 variables: histology and clinical symptoms. The study defines complete histological improvement as less than 5 eosinophils/high power field at 3 months, with partial improvement being a 50% reduction in eosinophils/high power field. Total absence of vomiting, heartburn, dysphagia, nausea, and abdominal pain will be defined as complete clinical improvement, with partial improvement being a 50% reduction of symptoms or less than one symptom per week. Of the 17 participants in the study with anti-IgE therapy, 5 showed at least partial clinical improvement, indicated by self-reported symptom survey results. Symptom surveys included assessments of severity (on a 1-5 scale) and frequency of vomiting, nausea, heartburn, dysphagia, and abdominal pain. Five of the 17 participants had no noteworthy change in symptoms, though 2 of these showed partial histological improvement. Another 5 participants displayed slight clinical improvement, meaning not a 50% reduction in overall symptom occurrence but a reduction in severity or occurrence of their most severe symptom. Of these 5 participants, only 1 showed partial histological improvement; the others had no improvement. Of the 5 participants with significant clinical improvement, 3 reported partial clinical improvement and 2 reported near-complete or complete symptom resolution. Those with partial clinical improvement had histological results as follows: 1 showed complete histological improvement, and 2 had partial improvement. One of the patients showing complete clinical improvement also had complete histological improvement, and the other showed partial histological improvement. Conclusion: The mechanism by which treatment methods are evaluated for medical conditions has to vary by the prevalence of the disease. Generally, when prevalent diseases","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"76 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131593685","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":"Evaluating the Content of Advertisements for Dietary Supplements in Malaysian Women’s Magazines","authors":"M. Hassali, F. Saleem, H. Aljadhey, T. Khan","doi":"10.1177/0092861512457777","DOIUrl":"https://doi.org/10.1177/0092861512457777","url":null,"abstract":"Advertising in printed media, including magazines, has become a vital source of information about dietary supplements for consumers. Within this context, the extent to which the manufacturers of these dietary supplements adhere to the standards and guidelines of good advertising practices remains relatively unexplored in Malaysia. The current study aimed to identify the purported health benefits of the advertised dietary supplements from selected women’s magazines and to evaluate the compliance of the advertisement contents with the Malaysian Advertisements Board (MAB) guidelines. The contents of 18 issues of popular women’s magazines in Malaysia were analyzed during a 1-month period in 2010. A total of 157 dietary supplement advertisements were analyzed and classified into 4 categories based on the ingredients, functional claims, the presence or absence of a Ministry of Health Advertising Approval Number (KKLIU), and violation of the MAB regulations. Chi-square analyses were used to investigate the association between the scores for MAB regulation violations and the advertised contents in the magazine. A total of 157 dietary supplement advertisements were analyzed. Malay herbs such as kacip fatimah ( Labisia pumila ), mas cotek ( Ficus deltoidea ), and tongkat ali ( Eurycoma longifolia ) were frequently advertised herbal products. Additional advertised substances included vitamins (n = 28, 17.8%), proteins (n = 16, 10.2%), and minerals (n = 15, 9.6%). The majority of the products (n = 21, 19.8%) declared cosmetic/beauty or antiaging functions, and 13.3% of the advertisements claimed to restore, improve, or enhance the sexual health of men or women. Overall, approximately 74.2% of the advertisements did not have KKLIU/MAL numbers. With regard to language, it was clear that the Malay-language magazines significantly violated the advertisement criteria of the MAB ( P <.05). Nearly all of the selected magazines in some way did not fulfill the advertising ethics outlined by the MAB.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"85 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123052557","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":"Content Analysis of the Videos Featuring Prescription Drug Advertisements in Social Media: YouTube","authors":"Mo Yang, Jeongeun Seo, A. Patel, S. Sansgiry","doi":"10.1177/0092861512462020","DOIUrl":"https://doi.org/10.1177/0092861512462020","url":null,"abstract":"The purpose of this study was to evaluate from a consumer’s perspective the content of digital video advertisements posted on the website https://doi.org/YouTube.com . Advertisements for the top-selling 25 prescription drugs were identified during a 1-month time period (September 2009) and were categorized as either regulated or unregulated by the FDA. Unregulated advertisements were further classified as educational (by health care professionals), commercial (to sell drugs or for lawsuit claims), or miscellaneous. Drug name, advertisement type, number of views, and rating by viewers were collected. The current sample consists of 11.4% FDA-regulated and 88.6% FDA-unregulated (15.4% educational, 5.8% commercial, and 88.8% miscellaneous) advertisements. FDA-unregulated advertisement videos had a higher number of average views (6318 ± 10,325) compared with FDA-regulated videos (6044 ± 10,991). As consumers are exposed to a large number of FDA-unregulated advertisements for prescription drugs on YouTube, education is needed to enable consumers to distinguish between FDA-regulated and FDA-unregulated videos.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127881254","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":"Review of Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional\u0000","authors":"E. Tabor","doi":"10.1177/0092861512460760","DOIUrl":"https://doi.org/10.1177/0092861512460760","url":null,"abstract":"tions are often followed by slightly different questions that serve to broaden the discussion. It is a large work: 811 pages, including a main section of questions and answers about clinical trial requirements in the US; a large section with questions and answers about clinical trials and GCP standards in Europe, South America, India, China, and Russia; and a large section containing the full text of applicable FDA regulations and guidances, as well as ICH guidances. It also has chapters on GCP regulations and guidelines, requirements for investigators, for sites, issues related to Form FDA-1572, clinical trial monitoring, informed consent, source documentation, clinical trial protocols, institutional review boards, safety reporting, FDA inspections, computerized records, patient recruitment, subject diaries, conflicts of interest, fraud, and the impact of the Health Insurance Portability and Accountability Act on clinical trials. For example, there is a 6-page discussion in response to a series of 5 questions about whether an investigational new drug application (IND) is needed for a phase IV study of an approved drug. Under a 2010 FDA draft guidance, an IND is needed for a phase IV study if the study will be used to support a change in the drug’s indication or a change in its advertising, as well as in certain situations where safety is an issue, and in a few other specialized situations. In general, however, FDA assumes that ‘‘any well-controlled [phase IV] trial of a marketed drug sponsored by the manufacturer of the drug would be [considered to be intended] to influence labeling or promotion in some way,’’ and therefore would usually be expected to be conducted under an IND, whereas a similar study conducted by an individual investigator in an academic setting could be conducted without an IND if it was not intended to support changes in indication or advertising. A follow-up question asks what happens if a ‘‘sponsor or investigator does not intend to use the results to support significant changes in a product’s approved labeling,’’ does the study without an IND, but later ‘‘changes his or her mind.’’ The book’s answer is that as long as a phase IV study was conducted in good faith under the terms of this exemption from filing an IND, FDA will later accept it in support of an IND or new drug application. One shortcoming of the printed version of the book is that there is no index. The eBook version does have a search function that can find keywords. Thus, this book is recommended mainly for browsing, reading, or study, and the writing style is appropriately pleasant for this. I enjoyed reading many of the discussions in this book, and I was impressed by their breadth and by the fact that I could not find any errors. This probably reflects a combination of the good editing that the book must have gone through and the fact that the answers in the book are the work of an ‘‘expert advisory panel.’’","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114423432","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":"Review of Good Clinical Practice: A Question & Answer Reference Guide\u0000","authors":"E. Tabor","doi":"10.1177/0092861512460235","DOIUrl":"https://doi.org/10.1177/0092861512460235","url":null,"abstract":"","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115116431","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":"Review of Clinical Trial Design: Bayesian and Frequentist Adaptive Methods\u0000","authors":"Richard C. Zink","doi":"10.1177/0092861512462372","DOIUrl":"https://doi.org/10.1177/0092861512462372","url":null,"abstract":"The subtitle of this book is ‘‘An in-depth guide to writing, editing, tracking, and submitting the original IND and applicable IND amendments.’’ This book is a clear and thorough guide to the preparation, writing, publishing, submission, and monitoring of documents that FDA requires drug sponsors to submit. Although the title and subtitle focus on IND submissions, in fact the book covers in depth a few other types of FDA submissions as well, such as orphan drug applications and FDA meeting requests. The book is set up like a training manual for those who are entering regulatory affairs for drug products, and it is a good one. It would be useful as a textbook for a regulatory affairs course or to study for certification. Although it is very basic, it might also be useful as a desk reference for a regulatory affairs department for a quick look at an applicable chapter when a quick answer is needed. Topics include all aspects of INDs, including administrative aspects of submissions (creating style guides and templates; tips on writing and coordinating writing by a group; FDA forms), paper and electronic submissions, tracking submissions, managing references, CTD format, electronic document management systems, FDA meetings, dispute resolution, expanded use INDs, exploratory INDs, IND amendments, protocols, transfers of obligations, investigator’s brochures, safety reports, fast-track designation, responding to clinical holds, special protocol assessments, statistical analysis plans, filing at clinicaltrials.gov, CMC issues, orphan drug issues, USAN and proprietary name development, inactivating and reactiving an IND, and drug master files. The book does not seem to miss any IND-related topics, and everything I read was very accurate and also easy to read. The organization of the book is roughly along the lines of how one would go about initiating and maintaining an IND. However, surprisingly many introductory concepts are not introduced until chapters 22, 26, and 27. This is a sizable book, with 530 pages of relatively large dimensions (approximately 11’’ 12’’). It has a plastic spiral binding, but that is mounted within an attractive solid hardcover backing. The spiral binding appears intended to allow readers to remove the spiral-bound pages from the hard cover so that pages can be turned back on the spiral. Each of the 62 chapters is marked with a thick-tabbed divider with each topic clearly marked on the tab, which is extremely convenient and makes its use as a reference tool easier, particularly since the book lacks an index. Its 33-page detailed table of contents partially compensates for this as well. One of the most impressive aspects of this book is the accompanying CD-ROM, containing template documents, arranged by chapter, for 54 of the chapters. With artificial ‘‘samples’’ of FDA meeting requests, completed FDA forms, etc, as well as a sample style guide and examples of the types of letters that FDA sends to drug sponsors, this CD-ROM col","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"62 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121391603","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}