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Database/Biostatistics Audits - from the Auditor's Perspective 数据库/生物统计审计-从审核员的角度
Pharmaceutical Programming Pub Date : 2010-06-01 DOI: 10.1179/174591910X12694280628997
B. Ryan
{"title":"Database/Biostatistics Audits - from the Auditor's Perspective","authors":"B. Ryan","doi":"10.1179/174591910X12694280628997","DOIUrl":"https://doi.org/10.1179/174591910X12694280628997","url":null,"abstract":"Abstract This paper discusses areas of data management and biostatistics audits that are of particular relevance to database and statistical programmers. The paper outlines the regulatory framework for data management and biostatistics audits and the techniques that may be employed by the auditor when reviewing some key topics: staff records, standard operating procedures (SOPs) and project-specific plans, records management, security, and validation.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"76 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114229160","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
Streamlining the PK/PD data transfer process 简化PK/PD数据传输流程
Pharmaceutical Programming Pub Date : 2010-06-01 DOI: 10.1179/175709310X12765210193226
A. Collins, M. Peterson, G. Silva
{"title":"Streamlining the PK/PD data transfer process","authors":"A. Collins, M. Peterson, G. Silva","doi":"10.1179/175709310X12765210193226","DOIUrl":"https://doi.org/10.1179/175709310X12765210193226","url":null,"abstract":"AbstractMost clinical trials involve collection and analysis of samples for use in pharmacokinetic (PK) and pharmacodynamic (PD) analysis. The routing of these samples and resultant data is often different from data from case reporting forms (CRFs) and clinical chemistry results. While most Biostatistics and Clinical Data Management (CDM) departments have well established standard processes for the handling data to populate and lock a clinical database at the conclusion of the trial, PK/PD data and dosing information that may be needed for construction of quantitative/predictive models during the conduct of the trial often are not covered by this organizational planning. Adding to the difficulties, for blinded studies, access to PK/PD data would compromise blinding. Thus, these data are routinely stored separate from the CRF and clinical chemistry results with access restricted. The results of separate storage and 'ad hoc' processing are inefficient processes and need for reinvention of data flow plans fo...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"133 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115460000","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
SAS/GRAPH®: should we use classic procedures or ODS templates? SAS/GRAPH®:我们应该使用经典程序还是ODS模板?
Pharmaceutical Programming Pub Date : 2010-06-01 DOI: 10.1179/175709310X12687464504479
Philip R. Holland
{"title":"SAS/GRAPH®: should we use classic procedures or ODS templates?","authors":"Philip R. Holland","doi":"10.1179/175709310X12687464504479","DOIUrl":"https://doi.org/10.1179/175709310X12687464504479","url":null,"abstract":"AbstractThere have been choices when producing graphic output for a long time, although Data Step Graphics Interface has never been that popular. However, now Graph Template Language has production status in SAS® 9.2, and there is a viable alternative to coding graphs using PROC GPLOT, or PROC GCHART, and ANNOTATE. This paper compares the different methods for creating graphical images for publication, looking at the ease of programming, program maintenance, platform independence, and image quality of each method.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"2013 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127303883","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
Access your data in an open manner 以开放的方式访问您的数据
Pharmaceutical Programming Pub Date : 2010-06-01 DOI: 10.1179/175709310x12765125101493
Steve Prust
{"title":"Access your data in an open manner","authors":"Steve Prust","doi":"10.1179/175709310x12765125101493","DOIUrl":"https://doi.org/10.1179/175709310x12765125101493","url":null,"abstract":"AbstractData processing does not necessarily fit iterative techniques and this paper examines the difficulties inherent in the processing implied using SET and MERGE processing in SAS. When we need to access disparate data either across observations or across datasets, it can result in complex, unwieldy code. In these situations, we can use the functionality of the OPEN and associated functions to flexibly access data, producing well-structured and concise code. The paper gives an overview of the functions associated with OPEN and demonstrates their use with the identification of subjects who satisfy algorithmic SMQs.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"123 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124282642","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
Global analysis and reporting standards: common data structures need common interpretation 全球分析和报告标准:通用数据结构需要通用解释
Pharmaceutical Programming Pub Date : 2010-06-01 DOI: 10.1179/175709310X12707176294425
S. Bamford, Benjamin Szilagyi
{"title":"Global analysis and reporting standards: common data structures need common interpretation","authors":"S. Bamford, Benjamin Szilagyi","doi":"10.1179/175709310X12707176294425","DOIUrl":"https://doi.org/10.1179/175709310X12707176294425","url":null,"abstract":"At this year’s FDA-DIA Conference for Computational Science, PhUSE had the opportunity to meet with representatives from the FDA and CDISC to discuss the status quo of industry standards and what opportunities lay ahead for further alignment and simplification across the dataflow from capture down to reporting results. Discussions were held in a collaborative and highly engaged spirit where it soon became evident that further standardization of efforts in the area of statistical reporting provides benefits for all parties involved, agencies as well as sponsor organizations. Of the over 200 delegates at the conference, more than 80 were from the FDA. The majority of the other delegates were companies and societies involved in standards rather than drug development companies. Almost all the delegates were from America although FDA Drug Submissions is a topic that affects drug development companies from around the world who want to submit their drug in America.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"89 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123105235","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
Medical device and diagnostic industry 101 for SAS® professionals SAS®专业人员医疗设备和诊断行业101
Pharmaceutical Programming Pub Date : 2010-06-01 DOI: 10.1179/175709310X12765117447327
Carey G. Smoak
{"title":"Medical device and diagnostic industry 101 for SAS® professionals","authors":"Carey G. Smoak","doi":"10.1179/175709310X12765117447327","DOIUrl":"https://doi.org/10.1179/175709310X12765117447327","url":null,"abstract":"Abstract Medical devices and diagnostics are increasingly important to the healthcare industry. The number of devices approved by the FDA has increased by 52% in the past decade. While devices are important in and of themselves, they are also increasingly more and more important in pharmaceutical research including diagnostic imaging used to monitor therapies, devices used to deliver drugs and diagnostic tests to determine if a patient will respond to a particular therapy. Devices are different from pharmaceutical products in terms of the FDA approval process, the use of CDISC standards and types of studies.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"18 2S1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133042264","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
Safety analysis using Bayesian simulation methods in SAS® 9.2 使用SAS®9.2的贝叶斯模拟方法进行安全性分析
Pharmaceutical Programming Pub Date : 2010-06-01 DOI: 10.1179/175709309X12560292099095
A. Gemperli
{"title":"Safety analysis using Bayesian simulation methods in SAS® 9.2","authors":"A. Gemperli","doi":"10.1179/175709309X12560292099095","DOIUrl":"https://doi.org/10.1179/175709309X12560292099095","url":null,"abstract":"AbstractBerry and Berry proposed a hierarchical model for the analysis of frequency counts of adverse events with one active treatment and one control group. For parameter estimation, a simulation-based Bayesian approach has been suggested. SAS® offers in version 9.2 for the first time a procedure that is able to fit models of any complexity using Bayesian simulation. This procedure – called Proc MCMC – is shipped as experimental version and offers all features to implement the Berry–Berry model in SAS. Proc MCMC allows various ways to code the problem. A successful implementation requires some understanding of the functioning of Proc MCMC as will be demonstrated.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"2014 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129867531","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
Creation of define.xml at Kendle using Definedoc™: implementation, obstacles and enhancements 在Kendle使用Definedoc™创建define.xml:实现、障碍和增强
Pharmaceutical Programming Pub Date : 2009-12-01 DOI: 10.1179/175709209X12535439079327
Emo¨ke Merli, E. Heimsch, E. Sennewald
{"title":"Creation of define.xml at Kendle using Definedoc™: implementation, obstacles and enhancements","authors":"Emo¨ke Merli, E. Heimsch, E. Sennewald","doi":"10.1179/175709209X12535439079327","DOIUrl":"https://doi.org/10.1179/175709209X12535439079327","url":null,"abstract":"AbstractIn their critical path initiative, the FDA underlines the urgent need for a standardized approach to capture, receive and analyse clinical study data. Providing the data definition document in a machine readable format such as XML increases the level of automation and improves the efficiency of the regulatory review process. Case report tabulation data definition specification (CRT DDS) is the CDISC standard for providing metadata in XML format for an electronic submission to regulatory authorities such as the FDA. This paper will describe how Kendle has implemented CRT DDS (commonly known as define.xml) Standards Version 1.0.0 at Kendle. Furthermore, it demonstrates how Kendle uses the SAS® based tool Definedoc™ from Meta-Xceed, Ind. (MXI) in the define.xml generation process. Also quality control processes developed by Kendle will be discussed and some interesting features of define.xml and issues encountered with the CDISC standards will be highlighted. This paper will describe the process and ...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"38 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115863592","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
Analysis of a three-period two-treatment pharmacokinetic study to assess scaled average bioequivalence 三期两疗程药代动力学研究的分析，以评估标度平均生物等效性
Pharmaceutical Programming Pub Date : 2009-12-01 DOI: 10.1179/175709309X12555196998522
J. Mueller-Cohrs
{"title":"Analysis of a three-period two-treatment pharmacokinetic study to assess scaled average bioequivalence","authors":"J. Mueller-Cohrs","doi":"10.1179/175709309X12555196998522","DOIUrl":"https://doi.org/10.1179/175709309X12555196998522","url":null,"abstract":"Abstract In the past years, various approaches for assessing bioequivalence of so-called 'highly variable drugs' have been debated. These are drugs whose pharmacokinetic profiles vary considerably when given to the same subject. As a consequence of the high variability, average bioequivalence between two such drugs can only be shown with an unfeasibly high number of subjects. Therefore, regulatory agencies generally agree that the criterion of average bioequivalence warrants adjustment for highly variable drugs. The mainstream of the most recent discussion favours an approach that is called scaled average bioequivalence. With this approach, the usual criterion of average bioequivalence is scaled by the within-subject standard deviation of the pharmacokinetic parameter in question. A parsimonious design for evaluating scaled average bioequivalence is a three-period two-treatment crossover trial where the reference drug is given twice and the investigational drug is given once to each subject. In this paper...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"286 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122977760","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
Pharmaceutical expectations and CRO expectations – how can we best get them to agree? 制药期望和CRO期望——我们如何才能最好地让它们达成一致?
Pharmaceutical Programming Pub Date : 2009-12-01 DOI: 10.1179/175709309X12560287687818
Karen F. Turner, Esther Bayon
{"title":"Pharmaceutical expectations and CRO expectations – how can we best get them to agree?","authors":"Karen F. Turner, Esther Bayon","doi":"10.1179/175709309X12560287687818","DOIUrl":"https://doi.org/10.1179/175709309X12560287687818","url":null,"abstract":"AbstractA large number of pharmaceutical companies now use contract resource organisations (CROs) for the reporting of their clinical trials, use in data monitoring committees (DMCs) or for consultancy work. High expectations are placed on the CRO to create the best possible results, in the fastest possible time for the least possible cost. This paper intends to explore the expectations from both interested parties, resulting in some possible solutions/suggestions to make the working relationship easier, more efficient and with less stress on either side.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"67 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123477686","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
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