Pub Date : 1982-07-01DOI: 10.1177/009286158201600305
E Akaho, A Miyake, N Yoshii, A Bandai, K Onoue
The Iowa Drug Information Service microfilm system has been evaluated fairly well. Tourville et. al. compared four drug information services, International Pharmaceutical Abstracts, Iowa Drug Information Service, deHaen Drugs in Research, and deHaen Drup in Use, and indicated that the Iowa Information SeMce appeared to have the highest overall relative utility for obtaining clinical information'. Madden d. al. compared nine drug information retrieval services of huge d e as well as of smal l scale, and stated that of smaller commercially available manual systems, the Iowa Drug Information Service was found to be the most comprehensive2. One of the advantage of the Iowa Drug Information Service microfilm'system over others is that it includes original articles. It is said that there are over 500 subscribers in the United States, Puerto Rico and 25 other countries. The effective usage of the system is believed to contribute to a successful drug information activity. This system has been utilized in the school of Pharmacy, KobeGakulin University as a tool for D I simulation activity for pharmacy students, and it is found that the manual
{"title":"Selector system design for the Iowa drug information service microfilm file.","authors":"E Akaho, A Miyake, N Yoshii, A Bandai, K Onoue","doi":"10.1177/009286158201600305","DOIUrl":"https://doi.org/10.1177/009286158201600305","url":null,"abstract":"The Iowa Drug Information Service microfilm system has been evaluated fairly well. Tourville et. al. compared four drug information services, International Pharmaceutical Abstracts, Iowa Drug Information Service, deHaen Drugs in Research, and deHaen Drup in Use, and indicated that the Iowa Information SeMce appeared to have the highest overall relative utility for obtaining clinical information'. Madden d. al. compared nine drug information retrieval services of huge d e as well as of smal l scale, and stated that of smaller commercially available manual systems, the Iowa Drug Information Service was found to be the most comprehensive2. One of the advantage of the Iowa Drug Information Service microfilm'system over others is that it includes original articles. It is said that there are over 500 subscribers in the United States, Puerto Rico and 25 other countries. The effective usage of the system is believed to contribute to a successful drug information activity. This system has been utilized in the school of Pharmacy, KobeGakulin University as a tool for D I simulation activity for pharmacy students, and it is found that the manual","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"16 3","pages":"131-6"},"PeriodicalIF":0.0,"publicationDate":"1982-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158201600305","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21129003","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}
Pub Date : 1982-07-01DOI: 10.1177/009286158201600303
T D Rucker
A formulary represents a compilation of pharmaceutical preparations. approved for use in a given environment. Application of this administrative device, therefore, is intended to restrict or guide prescribers when they order drug products for their patients. The central issues in formulary implementation thus revolve around (a) the intended objectives. (b) the process by which chemical agents achieve or lose formulary status, (c) the administrative impact, i.e., the effectiveness and efficiency with which these steps are carried out, and (d), the social results, indicated primarily by whether cost-benefit implications for patients appear to be positive. Before turning to our major concern, product accession and deletion, it may be useful to review selected
{"title":"Formularies: conceptual and experimental factors related to product selection.","authors":"T D Rucker","doi":"10.1177/009286158201600303","DOIUrl":"https://doi.org/10.1177/009286158201600303","url":null,"abstract":"A formulary represents a compilation of pharmaceutical preparations. approved for use in a given environment. Application of this administrative device, therefore, is intended to restrict or guide prescribers when they order drug products for their patients. The central issues in formulary implementation thus revolve around (a) the intended objectives. (b) the process by which chemical agents achieve or lose formulary status, (c) the administrative impact, i.e., the effectiveness and efficiency with which these steps are carried out, and (d), the social results, indicated primarily by whether cost-benefit implications for patients appear to be positive. Before turning to our major concern, product accession and deletion, it may be useful to review selected","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"16 3","pages":"115-21"},"PeriodicalIF":0.0,"publicationDate":"1982-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158201600303","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21128996","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}
Pub Date : 1982-07-01DOI: 10.1177/009286158201600309
R C Hatton, P L Doering, J L Frias
Physicians are frequently called upon to prescribe or give advice about drugs used during pregnancy. Many of these drugs are used effectively and without complications while others may adversely affect prenatal development. Information about risks, however, is scanty, not critically reviewed, and dispersed in the literature, seldom providing clinically useful information. The inadequacy of literature sources results partiaUy because of moral and legal considerations regarding research with pregnant women. Study of drug effects by conventional, prospective, double-blind techniques cannot be performed; therefore, alternative and less satisfactory study methods are employed. Animal studies cannot always be extrapolated to humans. Large scale retrospective studies often have numerous shortcomings including exposure to multiple drugs, the occurrence of confounding diseases, and incomplete or inacurate exposure data. Anecdotal case reports lack the controls necessary to establish causality and may, therefore, represent coincidental drug exposure in a child with a malformation produced by other causes. Thus, by dcfault, manufacturers must use the disclaiming statement, “Safety of the use of this drug during pregnancy has not
{"title":"Physicians' sources of information about teratogenic effects of drugs.","authors":"R C Hatton, P L Doering, J L Frias","doi":"10.1177/009286158201600309","DOIUrl":"https://doi.org/10.1177/009286158201600309","url":null,"abstract":"Physicians are frequently called upon to prescribe or give advice about drugs used during pregnancy. Many of these drugs are used effectively and without complications while others may adversely affect prenatal development. Information about risks, however, is scanty, not critically reviewed, and dispersed in the literature, seldom providing clinically useful information. The inadequacy of literature sources results partiaUy because of moral and legal considerations regarding research with pregnant women. Study of drug effects by conventional, prospective, double-blind techniques cannot be performed; therefore, alternative and less satisfactory study methods are employed. Animal studies cannot always be extrapolated to humans. Large scale retrospective studies often have numerous shortcomings including exposure to multiple drugs, the occurrence of confounding diseases, and incomplete or inacurate exposure data. Anecdotal case reports lack the controls necessary to establish causality and may, therefore, represent coincidental drug exposure in a child with a malformation produced by other causes. Thus, by dcfault, manufacturers must use the disclaiming statement, “Safety of the use of this drug during pregnancy has not","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"16 3","pages":"148-53"},"PeriodicalIF":0.0,"publicationDate":"1982-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158201600309","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21129002","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}
Pub Date : 1982-07-01DOI: 10.1177/009286158201600302
W M Heller
{"title":"Patient drug information from the health professionals.","authors":"W M Heller","doi":"10.1177/009286158201600302","DOIUrl":"https://doi.org/10.1177/009286158201600302","url":null,"abstract":"","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"16 3","pages":"112-4"},"PeriodicalIF":0.0,"publicationDate":"1982-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158201600302","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21128994","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}
Pub Date : 1982-01-01DOI: 10.1177/009286158201600109
T H Hunter
{"title":"Institutional review boards: informed consent and clinical trial ethics.","authors":"T H Hunter","doi":"10.1177/009286158201600109","DOIUrl":"https://doi.org/10.1177/009286158201600109","url":null,"abstract":"","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"16 1-2","pages":"56-9"},"PeriodicalIF":0.0,"publicationDate":"1982-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158201600109","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21130740","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}
Pub Date : 1982-01-01DOI: 10.1177/009286158201600110
J J Donahue
{"title":"Clinical trial management, quality assurance and sufficiency of data.","authors":"J J Donahue","doi":"10.1177/009286158201600110","DOIUrl":"https://doi.org/10.1177/009286158201600110","url":null,"abstract":"","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"16 1-2","pages":"60-3"},"PeriodicalIF":0.0,"publicationDate":"1982-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158201600110","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21187433","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}
Pub Date : 1982-01-01DOI: 10.1177/009286158201600117
A B Lisook
{"title":"FDA audit of investigators and sponsors.","authors":"A B Lisook","doi":"10.1177/009286158201600117","DOIUrl":"https://doi.org/10.1177/009286158201600117","url":null,"abstract":"","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"16 1-2","pages":"97-101"},"PeriodicalIF":0.0,"publicationDate":"1982-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158201600117","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21130735","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}
Pub Date : 1982-01-01DOI: 10.1177/009286158201600115
J K Jones
This conference has taken us from the early phases of drug development to the NDA, and this session dcals with issues that are critical in the final stages of NDA submission, and afterward. Dr. Borden and I will discuss post-marketing issues specifically. In chorus with the speakers earlier in the meeting, I contend that thinking of the post-marketing, or Phase IV stage of a drug should be part of the earlier planning in drug development. To that end, Figure 1 is a conceptual diagram of the accrual of the "volume" of knowledge of a drug during its phases of development. Although the volume increases, the knowledge about a drug is still incomplete at the time of NDA approval-the degree of incompleteness being somewhat dependent upon the newness of the molecular entity. With respect to adverse effects, the concept has been that studies and information acaued soon after approval [so called early post-marketing surveillance (PMS)] would round out the information gaps. Ideally,
{"title":"Post-marketing surveillance, annual reports and long term follow-up.","authors":"J K Jones","doi":"10.1177/009286158201600115","DOIUrl":"https://doi.org/10.1177/009286158201600115","url":null,"abstract":"This conference has taken us from the early phases of drug development to the NDA, and this session dcals with issues that are critical in the final stages of NDA submission, and afterward. Dr. Borden and I will discuss post-marketing issues specifically. In chorus with the speakers earlier in the meeting, I contend that thinking of the post-marketing, or Phase IV stage of a drug should be part of the earlier planning in drug development. To that end, Figure 1 is a conceptual diagram of the accrual of the \"volume\" of knowledge of a drug during its phases of development. Although the volume increases, the knowledge about a drug is still incomplete at the time of NDA approval-the degree of incompleteness being somewhat dependent upon the newness of the molecular entity. With respect to adverse effects, the concept has been that studies and information acaued soon after approval [so called early post-marketing surveillance (PMS)] would round out the information gaps. Ideally,","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"16 1-2","pages":"87-92"},"PeriodicalIF":0.0,"publicationDate":"1982-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158201600115","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21187435","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}
Pub Date : 1982-01-01DOI: 10.1177/009286158201600105
R J Crossley
This paper has presented certain concepts and thoughts regarding the planning process and dealt with two areas where planning and preconsideration of problems will aid in the quality, speed and efficiency of ones programs. The varied examples that have been cited are just that; they are not intended to be a comprehensive evaluation of all the aspects of the planning process or, for that matter, the selection of investigators or harmonization of data. They are intended instead to illustrate the way in which a comprehensive and thorough planning approach to project management can facilitate, ease and improve the quality of the work we do. The important point of this whole paper is not so much the individual benefits to be gained from any one of the systems described, but rather to illustrate as much as possible the value of planning in our process. It is incumbent on us to search for ways to improve the way in which we do or work. Standards have improved considerably over the years, but there is much room for further improvement; good clinical and scientific thought will inevitably continue to contribute to the improvement of those programs. The submission of this author, however, is that if we do these in advance, we will solve them a good deal faster and a good deal more efficiently than if we constantly react to new and developing problems.
{"title":"Project planning, investigator selection, data harmonization.","authors":"R J Crossley","doi":"10.1177/009286158201600105","DOIUrl":"https://doi.org/10.1177/009286158201600105","url":null,"abstract":"This paper has presented certain concepts and thoughts regarding the planning process and dealt with two areas where planning and preconsideration of problems will aid in the quality, speed and efficiency of ones programs. The varied examples that have been cited are just that; they are not intended to be a comprehensive evaluation of all the aspects of the planning process or, for that matter, the selection of investigators or harmonization of data. They are intended instead to illustrate the way in which a comprehensive and thorough planning approach to project management can facilitate, ease and improve the quality of the work we do. The important point of this whole paper is not so much the individual benefits to be gained from any one of the systems described, but rather to illustrate as much as possible the value of planning in our process. It is incumbent on us to search for ways to improve the way in which we do or work. Standards have improved considerably over the years, but there is much room for further improvement; good clinical and scientific thought will inevitably continue to contribute to the improvement of those programs. The submission of this author, however, is that if we do these in advance, we will solve them a good deal faster and a good deal more efficiently than if we constantly react to new and developing problems.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"16 1-2","pages":"35-43"},"PeriodicalIF":0.0,"publicationDate":"1982-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158201600105","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21187429","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}
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