Drug Information Journal最新文献

{"title":"Guide to Paediatric Clinical Research","authors":"U. Schaad","doi":"10.1177/009286150704100611","DOIUrl":"https://doi.org/10.1177/009286150704100611","url":null,"abstract":"ROSE, KLAUS, AND VAN DEN ANKER, JOHN N.: GUIDE TO PAEDIATRIC CLINICAL RESEARCH. BASEL, SWITZERLAND: KARGER, 2007, 138 PAGES. The widespread use in pediatric patients of medicines licensed only for adults is a matter of growing concern to the profession, governments, regulatory agencies, and the public. It stands to reason that drugs should be studied in children to determine their safety and efficacy in younger age groups. All textbooks and reviews proudly state that growth, differentiation, and maturation can alter the kinetics, end organ responses, and toxicities to drugs in the newborn, infant, child, or adolescent compared with the adult. Drugs are subject to licensing procedures to ensure their safety, effectiveness, and quality. Running such studies in children often poses substantial ethical, practical, and commercial problems. Therefore, scientific data on the use of many pharmaceutical products in children are lacking. Such nonvalidated drug use has been challenged as a fundamental denial of the legal and human rights of children. Among experts from academia, regulatory agencies, and pharmaceutical companies, there is consensus that more studies are needed, so that in the future children can be treated with drugs that have been properly evaluated for use in their particular age group. Recently, US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children. This book contains 15 contributions written by 26 authors who are accepted experts in pediatric clinical research, from academia and industry. All chapters summarize the actual knowledge, emphasizing European situations and recommendations. The main topics include the relevant legislative changes and guidelines, the operational and ethical challenges of research involving children, the practical aspects related to informed consent/assent, appropriate drug formulation, and sample collection and analysis. Special chapters deal with research in small infants and with the complex issue of developing new infant nutrition products. This informative and welcome textbook is full of scientific and practical content. It will help to shift pediatric drug development from exception to routine. This book is recommended for colleagues with clinical, academic, pharmaceutical, or regulatory backgrounds who are interested and involved in clinical research with infants and children.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"41 1","pages":"791"},"PeriodicalIF":0.0,"publicationDate":"2007-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286150704100611","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64842906","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":"Site Selection for Clinical Trials","authors":"J. de Silva","doi":"10.1177/00928615980320S116","DOIUrl":"https://doi.org/10.1177/00928615980320S116","url":null,"abstract":"Site selection is highly critical to the success of any clinical trial and should be made with utmost care. Proper site selection can not only cut down on the finuncial and monitoring resources required by a trial but it can also help establish the credibility/ acceptability of the data generated. Certain selection criteria should be applied to site selection of all clinical trials, though their relative importunce may vary according to the type/phuse of the trial, the trid objective(s), availablefunds/resources, and so forth. What cannot be ignored is the politicaUeconomic and regulatory climute/stability as these can vastly affect a site’s ability to deliver over the course of a trial.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"32 1","pages":"1257S - 1258S"},"PeriodicalIF":0.0,"publicationDate":"1998-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/00928615980320S116","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843512","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":"Current Practical Issues in Phase III Clinical Trials","authors":"J. de Silva","doi":"10.1177/009286159703100413","DOIUrl":"https://doi.org/10.1177/009286159703100413","url":null,"abstract":"Multinational pharmaceutical companies are looking into expanding Phase III clinical trials to regions outside of the United States, Europe, and Japan. Inclusion of Asian sites during drug development could shorten drug development time, perhaps decrease drug development cost, address the issue of ethnic diversity, and accelerate local registrational approvals. Typically, trials are discouraged during the post-new drug application (NDA) submission preapproval stage (Phase III B). With increasing market pressures, however, more and more Phase 111 B studies are being performed for foreign registration or marketing purposes. In order to successfully bid for Phase III participation, a region has to have investigators with proven track records, adequate centralized facilities, responsive regulatory authorities, and ready access. Through participation in multinational studies, a region can increase its visibility in the field of new drug development, facilitate technical transfer, build expertise in clinical trials, and enhance the international standing of opinion leaders. Being fully cognizant of the potential benefits of active involvement in new drug development, Taiwan has been gearing up for an expanded role.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"31 1","pages":"1155-1156"},"PeriodicalIF":0.0,"publicationDate":"1997-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159703100413","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843457","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":"Drug Eruptions: Allergic Reactions?","authors":"D. Bruynzeel","doi":"10.1177/009286159703100431","DOIUrl":"https://doi.org/10.1177/009286159703100431","url":null,"abstract":"Drugs often cause adverse reactions, many of which involve the skin. Life-threatening skin reactions such as toxic epidermal necrolysis are rare, just like anaphylactic shock. Less severe but still worrisome eruptions are abundant but may develop into serious reactions. Only a part (20%) of these eruptions are evoked by an allergic mechanism. Usually one does not know if the drug or a metabolite is the antigen. As a consequence, tests in vitro and in vivo will be rather unreliable. Negative tests are not helpful and not decisive as the test could be false negative. It might be necessary to carry out a provocation test, the gold standard. A provocation test is not without dangers and does not discriminate between allergic and nonallergic reactions. More clinically reliable skin and laboratory tests should be developed to identify allergic reactions and to detect the allergenicity of new drugs.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"31 1","pages":"1311-1316"},"PeriodicalIF":0.0,"publicationDate":"1997-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159703100431","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843467","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":"An Integrated Approach to Adverse Event Data Management","authors":"Robbert P. van Manen","doi":"10.1177/009286159603000316","DOIUrl":"https://doi.org/10.1177/009286159603000316","url":null,"abstract":"This paper presents an approach which allows companies to deal with some of the major problems associated with adverse event data management in both an effective and efficient way. It is based upon discussions with representatives of severalpharmaceutical and device manufacturing companies. The approach integrates adverse event data management with other, related activities in: procedures, systems, and organization. It provides sharing of data, work flow management, and document management. The benefits of such an approach are speed, efficiency, and auditability.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"30 1","pages":"731 - 736"},"PeriodicalIF":0.0,"publicationDate":"1996-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159603000316","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843407","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 New Written Summaries to Be Attached to the Expert Report — Concepts and Requirements","authors":"F. de Crémiers","doi":"10.1177/009286159603000310","DOIUrl":"https://doi.org/10.1177/009286159603000310","url":null,"abstract":"This paper covers recent revisions to the European Notice to Applicants. The structure of the notice and new requirements are covered. Written summaries with tabular overviews should now be attached to expert reports for certain categories of products. These summaries provide a summary of the data and are used by regulators to prepare their assessment reports. They should facilitate the assessment task and speed up the application process.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"30 1","pages":"675 - 678"},"PeriodicalIF":0.0,"publicationDate":"1996-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159603000310","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843397","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":"Immunotoxicity of Pharmaceuticals: An Introduction to the Workshop","authors":"J. W. van der Laan, Jack van der Dean","doi":"10.1177/009286159603000130","DOIUrl":"https://doi.org/10.1177/009286159603000130","url":null,"abstract":"THE IMMUNE SYSTEM IN man is an important system for the protection against invader(ing) bacteria, viruses, and parasites which cause illnesses of different degrees of seriousness. Disturbances of the immune system may lead to a higher susceptibility to microbial diseases and, often, natural resistance to foreign allograph, cancer, and autoimmunity. Xenobiotics such as certain environmental chemicals and some pharmaceuticals are recognized as disturbing factors. Immunotoxicology, the study of xenobiotics that alter immune function, is a rapid developing field. Thus far, development has focused on environmental chemicals with regard to guidelines and with most of the focus on methods development and validation in animals. In recent years, immunotoxicity in animals has provided sensitive methods for predicting immune dysfunctions in humans induced by xenobiotics.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"30 1","pages":"269 - 270"},"PeriodicalIF":0.0,"publicationDate":"1996-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159603000130","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843338","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":"Immunotoxicity of Pharmaceuticals: Conclusions of the Workshop","authors":"J. W. van der Laan, Jack van der Dean","doi":"10.1177/009286159603000138","DOIUrl":"https://doi.org/10.1177/009286159603000138","url":null,"abstract":"4. There was some concern expressed over approaches for the proper validation of immune function tests. Most tests have been examined in ring studies using known immunotoxicants with good results. Assays were generally characterized for sensitivity for detecting an immune alteration withOut reference to a “gold standard*” Validation is also necessary with respect to the selectivity of the immune","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"30 1","pages":"313 - 314"},"PeriodicalIF":0.0,"publicationDate":"1996-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159603000138","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843386","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":"European Legislation and Research Projects regarding Patient Education for Medication","authors":"R. Vander Stichele, Marc G. Vander Bogaert","doi":"10.1177/009286159502900130","DOIUrl":"https://doi.org/10.1177/009286159502900130","url":null,"abstract":"In 1992 the European Community adopted Directive 92/27/EEC “On the labeling of medicinal products for human use and on package leaflets,’’ implementing the mandatory inclusion of full in formation leaflets written in understandable language in every medication package between January I , 1994 and December 31,1998. This article describes the features and historical motives of this new legislation. In addition, it reviews European research projects on the impact of written medication in formation.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"29 1","pages":"285 - 290"},"PeriodicalIF":0.0,"publicationDate":"1995-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159502900130","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843327","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":"Statistical Issues in the Design and Analysis of Ulcer Healing and Recurrence Studies","authors":"G. Koch, I. Amara, J. Forster, D. Mcsorley, Karl E. Peace","doi":"10.1177/009286159302700323","DOIUrl":"https://doi.org/10.1177/009286159302700323","url":null,"abstract":"Statistical considerations are discussed for a randomized parallel groups study to compare treatments for the healing of ulcers during a specified time period of dosing and for the avoidance of subsequent ulcer recurrence (in patients with healing) during a follow-up period with no medication. For this study, randomization enables valid comparisons of treatments for the rates of healing during the dosing period and for the cumulative rates of being ulcer-free (ie, healing and no recurrence subsequent to healing) during the combined dosing and follow-up periods. Appropriate methods of analysis include Mantel-Haenszel tests and logistic regression for dichotomous outcomes and their life table counterparts for time to event outcomes. For recurrence rates among patients with healing, the basis for comparisons among treatments is unclear because of potential lack of similarity of treatment groups for risk factors for recurrence at the beginning of the follow-up period. This difficulty can be addressed by interpreting recurrence rates within treatment groups as descriptive for corresponding populations with healing. Moreover, such descriptions can involve statistical models which account for the effects of risk factors. Consideration is additionally given to sample size determination and other aspects of the design for a healing and recurrence study.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"27 1","pages":"805 - 824"},"PeriodicalIF":0.0,"publicationDate":"1993-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159302700323","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843287","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}