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The use of checksums to ensure data integrity in the healthcare industry 使用校验和来确保医疗保健行业的数据完整性
Pharmaceutical Programming Pub Date : 2012-12-01 DOI: 10.1179/1757092112Z.0000000006
Carey G. Smoak, M. Widel, Sy Truong
{"title":"The use of checksums to ensure data integrity in the healthcare industry","authors":"Carey G. Smoak, M. Widel, Sy Truong","doi":"10.1179/1757092112Z.0000000006","DOIUrl":"https://doi.org/10.1179/1757092112Z.0000000006","url":null,"abstract":"AbstractWant to ensure data integrity? Want to know if a file has been altered? Checksum, please! Checksums have a variety of applications, such as verifying that an application has been installed correctly and providing a method of verifying whether or not a file has been altered. For example, checksums can be used in a SAS® program to verify that a comma delimited (comma-separated values, CSV) file has not been altered before importing the CSV file into a SAS dataset. Fortunately, all operating systems have some utility available to do checksums. This paper will provide some background on the use of checksums and concentrate on a particular example using lab instrument data.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"50 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122489712","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
Bootstrap simulations to estimate overall survival based on the distribution of a historical control 基于历史控制分布估计总体生存的自举模拟
Pharmaceutical Programming Pub Date : 2012-12-01 DOI: 10.1179/1757092112Z.0000000005
A. Nieto, Javier Gómez
{"title":"Bootstrap simulations to estimate overall survival based on the distribution of a historical control","authors":"A. Nieto, Javier Gómez","doi":"10.1179/1757092112Z.0000000005","DOIUrl":"https://doi.org/10.1179/1757092112Z.0000000005","url":null,"abstract":"Following the calculation of the median overall survival (OS) in a clinical trial, it is often desirable to put the estimates into perspective by comparing them with the results of other studies reported in the current bibliography. The main limitation of this comparison is the different distribution of prognostic baseline characteristics between studies. A SAS® program to obtain a bootstrap estimation for the median OS, balancing it by the historical distribution, is described herein.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121058032","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: 0
Merging RTF files using SAS®, MSWord®, and Acrobat Distiller® 使用SAS®，MSWord®和acrobatdistiller®合并RTF文件
Pharmaceutical Programming Pub Date : 2012-12-01 DOI: 10.1179/1757092112Z.0000000008
Oliver Wirtz
{"title":"Merging RTF files using SAS®, MSWord®, and Acrobat Distiller®","authors":"Oliver Wirtz","doi":"10.1179/1757092112Z.0000000008","DOIUrl":"https://doi.org/10.1179/1757092112Z.0000000008","url":null,"abstract":"Producing tables, listings, and figures (TLF) is one of the key responsibilities for programmers in the pharmaceutical industry. While SAS® Software offers a wide range of procedures to produce outputs in nearly all possible formats, collating multiple documents into an overall PDF file is not a trivial task. This paper will combine main aspects and show how you can implement this procedure within your organization. All you need is SAS, MSWord® and Acrobat Distiller®.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114320415","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: 0
Executable code: what, why and how 可执行代码:什么，为什么和如何
Pharmaceutical Programming Pub Date : 2012-12-01 DOI: 10.1179/1757092112Z.00000000011
Hiren Naygandhi
{"title":"Executable code: what, why and how","authors":"Hiren Naygandhi","doi":"10.1179/1757092112Z.00000000011","DOIUrl":"https://doi.org/10.1179/1757092112Z.00000000011","url":null,"abstract":"The pharmaceutical industry is continually evolving as it meets the on-going demands of external pressures such as rising development costs, patents, regulatory bodies and patients. Programmers can contribute by, accelerating the time to approval; ensuring patients receive treatment as quickly as possible. One area in particular where programmers can make a difference in accelerating the decision making, is by providing health authorities with executable code as part of the e-submission in the US. At Roche we have developed a standard approach with tools to facilitate this process.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"9 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131722677","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: 0
Processing of hierarchical data with hash objects Part 1 – Creation of XML documents 使用散列对象处理分层数据。第1部分-创建XML文档
Pharmaceutical Programming Pub Date : 2012-12-01 DOI: 10.1179/1757092112Z.0000000003
J. Hinson
{"title":"Processing of hierarchical data with hash objects Part 1 – Creation of XML documents","authors":"J. Hinson","doi":"10.1179/1757092112Z.0000000003","DOIUrl":"https://doi.org/10.1179/1757092112Z.0000000003","url":null,"abstract":"AbstractThe introduction of hash objects with SAS® version 9 brought about new opportunities for novel programming techniques. The recent discovery that hash tables can contain even other hash objects, also known as the ‘hash of hashes’, opens the door to their application to hierarchical data structures. This is because hierarchies, like the XML structure, can be considered ‘containers within containers’, and with the hash-of-hashes technique, tables can contain tables, thereby becoming compatible with hierarchical formats. This has the potential of being useful for processing clinical data in XML format. The advent of Clinical Data Interchange Standards Consortium (CDISC) and its increasing reliance on XML technology for handling clinical trial data implies that clinical SAS® programmers now have to get used to hierarchical data structures. Clinical trial data set submissions now have to be accompanied by metadata such as define.xml. The traditional SAS® data sets are tabular and relational, whereas the...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133278375","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
Programming challenges of sampling controls to cases from the dynamic risk sets in nested case control studies 在嵌套病例控制研究中，从动态风险集对病例进行抽样控制的编程挑战
Pharmaceutical Programming Pub Date : 2012-12-01 DOI: 10.1179/1757092112Z.0000000004
V. Kiri
{"title":"Programming challenges of sampling controls to cases from the dynamic risk sets in nested case control studies","authors":"V. Kiri","doi":"10.1179/1757092112Z.0000000004","DOIUrl":"https://doi.org/10.1179/1757092112Z.0000000004","url":null,"abstract":"Pharmacoepidemiological studies based on the cohort design are simpler to analyse and their results easier to interpret. However, these may not reflect real-life drug use which is a major strength of such studies. The nested case–control design is often used instead to avoid the computational burden associated with time-dependent explanatory variables. Unlike the classical case–control design which is generally easy to programme, that of the nested case–control can pose a number of challenges. Subjects can be chosen as controls more than once and a subject who is chosen as a control can later become a case. Indeed controls are chosen from among those in the cohort who are at risk of the event at that time (i.e. we sample from the risk set defined by the case). We highlight the main programming challenges of the design as well as describe and demonstrate approaches for resolution and appropriate implementation.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"51 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124952535","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: 4
The Italian post-marketing registries 意大利上市后注册
Pharmaceutical Programming Pub Date : 2012-12-01 DOI: 10.1179/1757092112Z.0000000009
E. Xoxi, C. Tomino, L. D. Nigro, L. Pani
{"title":"The Italian post-marketing registries","authors":"E. Xoxi, C. Tomino, L. D. Nigro, L. Pani","doi":"10.1179/1757092112Z.0000000009","DOIUrl":"https://doi.org/10.1179/1757092112Z.0000000009","url":null,"abstract":"AbstractThe post-marketing registries, established by the Italian Medicines Agency in 2005, represent the example of a national application of an automated workflow handling the personalized drug distribution in hospital pharmacies and local public pharmaceutical services, with the intent of both improving the efficacy/efficiency of analysis and regulatory activities themselves, as well as closely monitoring the clinical activity. In fact, within the correct clinical practice the prescriber shall take into account the parameters, such as therapeutic drug indication, actual benefit the patient should gain in comparison to the trials, potential and actual risk of adverse reactions, drugs interactions, and cost of the therapy. On the track of the cancer registry’s experience, the Italian Medicines Agency has extended the scope to the following areas: ophthalmology, rheumatology, dermatology, orphan drugs, cardiology, diabetology, respiratory, and neurological diseases. It involves more than 60 drugs (most of...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130064317","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: 16
Approaches to creating ADaM subject-level analysis datasets (ADSL) for integrated analyses 为集成分析创建ADaM主题级分析数据集(ADSL)的方法
Pharmaceutical Programming Pub Date : 2012-12-01 DOI: 10.1179/1757092112Z.00000000010
N. Freimark
{"title":"Approaches to creating ADaM subject-level analysis datasets (ADSL) for integrated analyses","authors":"N. Freimark","doi":"10.1179/1757092112Z.00000000010","DOIUrl":"https://doi.org/10.1179/1757092112Z.00000000010","url":null,"abstract":"AbstractWhen it comes to integration the SDTM Model and IG do not give very much guidance. There is much discussion about the need for Integrated Summary of Safety (ISS)/Integrated Summary of Efficacy (ISE) level SDTM datasets and how to create those versus not needing integrated SDTM. The SDS and ADaM team have a subteam that are working to address this topic, but the work is still in early development. From an ADaM perspective, there is generally a requirement for integrated analysis datasets. There are many ADaM variables that have to be modified or added to allow for integrated analyses. Whether these datasets can or should be created on a project level and just stacked together for ISS/ISE analysis or if there is a need for the creation of integrated datasets depends on the nature of the variable updates and requirements. ADSL can present a unique set of challenges. Whether there should be one record per subject or one record per subject per study, treatment start and stop dates and groupings for ana...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123087973","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
A peak at PK — an introduction to pharmacokinetics 在PK的高峰-药物动力学的介绍
Pharmaceutical Programming Pub Date : 2012-12-01 DOI: 10.1179/1757092112Z.0000000007
H. Twitchett, P. Grimsey
{"title":"A peak at PK — an introduction to pharmacokinetics","authors":"H. Twitchett, P. Grimsey","doi":"10.1179/1757092112Z.0000000007","DOIUrl":"https://doi.org/10.1179/1757092112Z.0000000007","url":null,"abstract":"The aim of this paper is to give a high level introduction into pharmacokinetic (PK) data and analysis for programmers new to PK, or who require a refresher. Key theoretical concepts will be covered, such as: absorption, distribution, metabolism, and elimination (ADME), derived PK parameters, including area under the curve (AUC), Cmax (maximum concentration observed), tmax (time of maximum concentration observed), and t1/2 (half-life), and steady state. The data flow from CRF to tables, figures and listings (TFLs) will also be covered. We shall also briefly discuss the use of PK in the drug development process including types of clinical studies, e.g. single ascending dose (SAD), multiple ascending dose (MAD), bioavailability, mass balance, food effect, and drug–drug interaction (DDI) studies, and how this relates to the PK of the drug.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134071885","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
MACUMBA — a modern SAS GUI — debugging made easy MACUMBA -一个现代SAS GUI -调试变得容易
Pharmaceutical Programming Pub Date : 2012-12-01 DOI: 10.1179/1757092112Z.00000000012
Michael Weiss
{"title":"MACUMBA — a modern SAS GUI — debugging made easy","authors":"Michael Weiss","doi":"10.1179/1757092112Z.00000000012","DOIUrl":"https://doi.org/10.1179/1757092112Z.00000000012","url":null,"abstract":"MACUMBA is an application for SAS® programming developed in house at Bayer. It combines the interactive development features of SAS for Windows, the possibility of a client — server environment and unique ‘state of the art’ features that are missing in other SAS development environments. This paper covers some of the unique features that are related to SAS code debugging. This paper will begin by comparing the systems special code execution modes with the way this would be performed in interactive SAS. This paper will continue by presenting an overview of the graphical implementation of the single step debugger for SAS macros and DATA Steps. Finally, this paper will highlight the main issues faced during the development of MACUMBA.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"53 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123796036","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: 0
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