Drug Information Journal最新文献_第7页

Inspection of computer-supported toxicological data submitted to the FDA. 检查提交给FDA的计算机支持的毒理学数据。

Drug Information Journal Pub Date : 1984-01-01 DOI: 10.1177/009286158401800209

D W Taylor

引用次数: 3

The Australian method of drug-event assessment. Special workshop--regulatory. 澳大利亚药物事件评价方法。特殊的研讨会——监管。

Drug Information Journal Pub Date : 1984-01-01 DOI: 10.1177/009286158401800313

M L Mashford

引用次数: 33

The Swedish drug-event assessment methods. Special workshop--regulatory. 瑞典药物事件评价方法。特殊的研讨会——监管。

Drug Information Journal Pub Date : 1984-01-01 DOI: 10.1177/009286158401800312

B E Wiholm

引用次数: 17

MRIDIR--a system for integrating research databases. MRIDIR——一个整合研究数据库的系统。

Drug Information Journal Pub Date : 1984-01-01 DOI: 10.1177/009286158401800205

R E Carhart

引用次数: 1

Aspects of standardization as applied to the assessment of drug-event associations. 应用于药物事件关联评估的标准化方面。

Drug Information Journal Pub Date : 1984-01-01 DOI: 10.1177/009286158401800303

J Venulet

{"title":"Aspects of standardization as applied to the assessment of drug-event associations.","authors":"J Venulet","doi":"10.1177/009286158401800303","DOIUrl":"https://doi.org/10.1177/009286158401800303","url":null,"abstract":"Individual case reports about suspected adverse drug reactions are an important source of drug safety data. Their evaluation involves, among other things, the assessment of causality. Usually it is done by expert medical evaluators according to their knowledge and experience. Subjectivity plays a big role as demonstrated by comparison of assessments of the same cases by several evaluators or by the same evaluator at a later date. In recent years, methods of causality assessment based on algorithms were introduced. In these formal approaches, items of information contribute to the assessment in a predetermined and standardized way with a logic that allows operational application. Results obtained with different methods may differ because items of information considered may not be the same and/or strength of evidence attached to them vary from one method to another. The main advantages of standardized assessment are: clear identification of items of information involved, improved communication, reproducibility of results, and the checklist function. Various implications of standardized assessment are discussed and ways to improve their performance outlined.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"18 3-4","pages":"199-210"},"PeriodicalIF":0.0,"publicationDate":"1984-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158401800303","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21140008","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: 20

A clinical database management system. 临床数据库管理系统。

Drug Information Journal Pub Date : 1984-01-01 DOI: 10.1177/009286158401800108

S Schwartz, R George, J Owenr, J Edson

引用次数: 5

National drug formularies: lessons from Latin America. 国家药物处方:来自拉丁美洲的经验教训。

Drug Information Journal Pub Date : 1983-01-01 DOI: 10.1177/009286158301700206

A A LeRoy, M L Morse

{"title":"National drug formularies: lessons from Latin America.","authors":"A A LeRoy, M L Morse","doi":"10.1177/009286158301700206","DOIUrl":"https://doi.org/10.1177/009286158301700206","url":null,"abstract":"Although pharmaceuticals comprise up to 40% of the health care budget in developing countries, the majority of the population does not have access to many of the essential drugs needed to treat prevalent diseases. This situation demands the development of a national formulary of essential drugs for the public sector. The approach used in developing countries is to select drugs of choice for the treatment of prevalent morbidities and avoid therapeutic duplication, unacceptably dangerous drugs, or drugs of unproven efficacy. Drugs are selected based on a review of the prevalent morbidities, health care worker training, patient characteristics, and efficacy/risk information resulting from scientifically sound studies. An added component to the formulary is the inclusion of concise, unbiased prescribing information for each drug selected. A number of product selection guidelines were proven to be effective in establishing and maintaining an essential drug formulary for developing countries. These guidelines include: 1. Selection of drugs with proven efficacy and acceptable risk; 2. Selection of minimum number of drugs needed to treat the prevalent diseases; 3. Inclusion of new products only if they are found to have distinct advantages over products currently in use; 4. Inclusion of combination products only when they provide true benefit over single ingredients; 5. Selection of drugs with clear \"drug of choice\" indications for prevalent diseases; 6. Evaluation of the administrative and cost impact of products; and 7. Selection of drugs with established high quality.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"17 2","pages":"89-94"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158301700206","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21132493","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

The role of data organization in the evaluation of toxicology studies in drug application. 数据组织在药物应用毒理学研究评价中的作用。

Drug Information Journal Pub Date : 1983-01-01 DOI: 10.1177/009286158301700303

V C Glocklin

{"title":"The role of data organization in the evaluation of toxicology studies in drug application.","authors":"V C Glocklin","doi":"10.1177/009286158301700303","DOIUrl":"https://doi.org/10.1177/009286158301700303","url":null,"abstract":"One goal of the FDA's ongoing New Drug Regulations rewrite project is to facilitate and expedite drug application review. We believe that this can be aided by improved and consistent organization of the submissions. Therefore, guidelines are being developed to assist applicants in preparing well-structured summaries and full report sections. The proposed format guideline for toxicology and related studies is not intended to increase the amount of documentation beyond what is already required by the GLP regulations, but rather to provide some principles for orderly and coherent submission to aid comparative review of various types of data within and between studies. Certain of these principles may also be applicable to submission of data during the IND. The computer's role as an important, even essential, adjunct to this process is clearly evident. However, it is particular important that data automation be flexible enough to recognize and reconcile the differing perspectives of data collection and storage, and data retrieval and organization to benefit scientific evaluation of a drug application. Examples of recurring problems in the submission of computerized toxicology data are presented to illustrate their frustrating or confounding effect on the scientific evaluation of drug applications.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"17 3","pages":"139-51"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158301700303","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21186628","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

The mechanics of assembling an international drug dossier. 组装国际药物档案的机制。

Drug Information Journal Pub Date : 1983-01-01 DOI: 10.1177/009286158301700302

P V Buday

引用次数: 0

A comparison of pharmaceutical manufacturers as a source of drug information to a telephone inquiry: generic vs brand. 作为药品信息来源的制药商与电话查询的比较:仿制药与品牌药。

Drug Information Journal Pub Date : 1983-01-01 DOI: 10.1177/009286158301700308

J A Generali, L Hogan

{"title":"A comparison of pharmaceutical manufacturers as a source of drug information to a telephone inquiry: generic vs brand.","authors":"J A Generali, L Hogan","doi":"10.1177/009286158301700308","DOIUrl":"https://doi.org/10.1177/009286158301700308","url":null,"abstract":"A telephone survey was conducted to evaluate and compare drug information received from the pharmaceutical manufacturer in response to a drug interaction question concerning concurrent administration of tetracycline and cimetidine. This study assumes that the pharmaceutical company may often be consulted by the hospital pharmacist seeking information about a particular medication. Forty-five pharmaceutical companies, all marketing tetracycline products, were selected for the study. A conversation protocol was utilized. It was designed to assure consistency and evaluate information received for accuracy, response time, clinical judgement offered, and referrals. Forty pharmaceutical manufacturers responded: 18 brand manufacturers and 22 generic companies. Eleven companies provided information on the interaction identified. Five manufacturers stated that there were no contraindications to concurrent administration of the drugs, one company identified a similar interaction, and five manufacturers successfully provided information identifying the interaction with supportive documentation. Two of the five companies offered clinical judgement as to the clinical significance of the interaction. Both reached different conclusions. The mean time of all phone calls was 4.29 minutes (range 0.39 to 15.41 minutes). The investigator was referred to outside sources by twelve companies. In this study, brand manufacturers performed better than generic companies. Results indicate that few manufacturers are organized to answer drug information requests involving current information sources in a response to a telephone request.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"17 3","pages":"195-204"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158301700308","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21131849","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: 9