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Impact of daylight saving time shifts on data quality of a pharmacokinetic study 夏时制对药代动力学研究数据质量的影响
Pharmaceutical Programming Pub Date : 2011-12-01 DOI: 10.1179/175709311X13147964247017
S. Ahrweiler
{"title":"Impact of daylight saving time shifts on data quality of a pharmacokinetic study","authors":"S. Ahrweiler","doi":"10.1179/175709311X13147964247017","DOIUrl":"https://doi.org/10.1179/175709311X13147964247017","url":null,"abstract":"AbstractTwice a year, most areas of North America and Europe observe a time shift. In spring, a positive shift occurs when clocks are reset from 02:00 to 03:00 hours, generally on a Sunday morning. In late autumn, a negative shift occurs when clocks are reset from 03:00 to 02:00 hours, generally on a Sunday morning. These time shifts can have an impact on the data quality if they are not considered appropriately. Especially for pharmacokinetic studies, this can lead to issues and wrong results in the calculation of time-dependent variables like area under the curve (AUC) or terminal half-life (t 1/2). It also affects recording of safety data like adverse events or serial ECGs. This paper describes possible pitfalls in the study set-up and possible impact on data quality and analysis. It also shows traceable data handling options in case a solution in the data collection cannot be achieved.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"546 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116710800","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
Use of ODS tagsets.excelxp to create Excel type files 使用ODS标记集。excelxp创建Excel类型文件
Pharmaceutical Programming Pub Date : 2011-12-01 DOI: 10.1179/175709311X13166801334190
Douglas Staddon
{"title":"Use of ODS tagsets.excelxp to create Excel type files","authors":"Douglas Staddon","doi":"10.1179/175709311X13166801334190","DOIUrl":"https://doi.org/10.1179/175709311X13166801334190","url":null,"abstract":"AbstractExcel files are widely understood in many departments within an organization so if you can create them easily this should aid communication and data quality. This paper will show how to use ODS tagsets.excelxp to create XML files that can be opened in Excel just like a normal spreadsheet. Case study data from the CDISC pilot study1 has been used to demonstrate the benefits and problems encountered. An XML file was created for each patient in the study with separate tabs per raw dataset and also a file of the whole database.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121714741","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
PROC MIXED and early phase trials 混合过程和早期试验
Pharmaceutical Programming Pub Date : 2011-12-01 DOI: 10.1179/175709311X13166801334073
Shelley Fordred
{"title":"PROC MIXED and early phase trials","authors":"Shelley Fordred","doi":"10.1179/175709311X13166801334073","DOIUrl":"https://doi.org/10.1179/175709311X13166801334073","url":null,"abstract":"AbstractPROC MIXED is commonly being used to compare treatment or other differences in phase 1 crossover trials. In such trials there is variation between subjects and also variation within subjects — these two sources of variation can be described by random effects. PROC MIXED is used because it can accommodate for random effects and as opposed to other SAS regression procedures, subjects with missing observations can be handled without removing all of their data from the analysis. A fixed effect is a parameter which is modelled in the same way as in PROC GLM — there are pre-specified levels of that effect, e.g. treatment group which is pre-defined in a trial because the aim is to compare responses among the fixed groups. In contrast a random effect is a parameter whose values cause a random variability within a trial and whose values are not known pre-trial, e.g. the subjects' responses in a trial. So commonly, subject is declared as a 'random' parameter in PROC MIXED to account for this random variatio...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132368228","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
Application of component-wise rank method to bivariate bioequivalence case 成分秩法在二元生物等效性研究中的应用
Pharmaceutical Programming Pub Date : 2011-12-01 DOI: 10.1179/175709311X13147863610808
S. Nandakumar, J. McKean
{"title":"Application of component-wise rank method to bivariate bioequivalence case","authors":"S. Nandakumar, J. McKean","doi":"10.1179/175709311X13147863610808","DOIUrl":"https://doi.org/10.1179/175709311X13147863610808","url":null,"abstract":"AbstractOne of the most common analyses in pharmaceutical research is bioequivalence test of two drugs. The FDA has endorsed the usage of Schuirmann's two one-sided hypotheses for the analyses in such studies. Generally, however, several measures on the drugs are taken simultaneously such that the data are multivariate. Nandakumar and McKean generalized Schuirmann's procedure to this multivariate setting. For bivariate data, the results can be summarized in a graphical display. These procedures are least-squares-type procedures and hence, are quite sensitive to mild outliers. To counter this sensitivity, Nandakumar and McKean also developed a simple highly efficient and robust analogue to their multivariate least-squares procedure. The robust results can also be displayed graphically, overlaid with the least-squares graphical results. In this paper, a SAS algorithm is presented, which implements these least-squares and robust multivariate tests for bioequivalence, including their graphical summaries.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123323608","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
How do we ensure the programmers we have today will meet the business needs of tomorrow 我们如何确保今天的程序员能够满足明天的业务需求
Pharmaceutical Programming Pub Date : 2011-12-01 DOI: 10.1179/175709311X13152981934794
C. Leigh, Karen Rowe
{"title":"How do we ensure the programmers we have today will meet the business needs of tomorrow","authors":"C. Leigh, Karen Rowe","doi":"10.1179/175709311X13152981934794","DOIUrl":"https://doi.org/10.1179/175709311X13152981934794","url":null,"abstract":"AbstractThe company expectations of our programmers are evolving, driven by changing business, economic, technological, and regulatory environments. The drive to increase efficiency, work globally, be innovative, and still deliver quality has meant that both the roles of the programmer and the manager are changing. Programmers are now expected to have an extended range of skills both technical and soft to enable them to be an active participant in the drug development process. The manager plays a key role in setting the expectations and facilitating change needed to maximize efficiency. If we equip our programmers with the skill set to take on change and managers with a tool kit to support change, we create an environment in which innovation can flourish, the company benefits, and individuals feel valued. The benefit to you is a motivated, multi-skilled programmer who is equipped to meet the ever changing environment that we face.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121553670","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
SAS dataset utility with excel output SAS数据集实用程序与excel输出
Pharmaceutical Programming Pub Date : 2011-12-01 DOI: 10.1179/175709311X13166801334154
Robert Horton
{"title":"SAS dataset utility with excel output","authors":"Robert Horton","doi":"10.1179/175709311X13166801334154","DOIUrl":"https://doi.org/10.1179/175709311X13166801334154","url":null,"abstract":"AbstractThere may be a requirement to check that dataset creation dates are later than a certain point in time. A quick utility that allows for checking of file creation dates or to check that previously empty datasets are now populated may be of use in many situations. One such utility can be run by the programmer: an XML file is generated and a non-programmer can then check output without having to use SAS®. There are options to run over multiple study areas, to exclude a particular list of files, and to change cell background based on size or date. This presentation will go through the set-up of the macro to produce output files which can be tailored to study specifications.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"231 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115500758","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 — 1 year later 简化PK/PD数据传输过程- 1年后
Pharmaceutical Programming Pub Date : 2011-12-01 DOI: 10.1179/175709311X13166801333993
A. Collins, G. Silva
{"title":"Streamlining the PK/PD data transfer process — 1 year later","authors":"A. Collins, G. Silva","doi":"10.1179/175709311X13166801333993","DOIUrl":"https://doi.org/10.1179/175709311X13166801333993","url":null,"abstract":"AbstractThis paper is a follow-up to a paper in issue 3.1 of the Pharmaceutical Programming Journal where we provided an overview of the pharmacokinetics and pharmacodynamics (PK/PD) component of clinical trials as well as an initiative taken by the Biostatistics and Drug Metabolism and Pharmacokinetics (DMPK) departments at Biogen IDEC to develop more efficient processes for the handling and flow of PK/PD data in clinical trials. In this paper we describe the implementation of procedures developed in the initiative and the impact they have had on several clinical programs at Biogen. We have concluded that having a formal PK/PD data flow process has given the DMPK Scientists a place at the table when designing and conducting clinical trials as well as creating efficiencies for all involved functions.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115987663","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
Tracing Data Elements through a Standard Data Flow 通过标准数据流跟踪数据元素
Pharmaceutical Programming Pub Date : 2011-12-01 DOI: 10.1179/175709311X13166801334352
Alistair Dootson
{"title":"Tracing Data Elements through a Standard Data Flow","authors":"Alistair Dootson","doi":"10.1179/175709311X13166801334352","DOIUrl":"https://doi.org/10.1179/175709311X13166801334352","url":null,"abstract":"AbstractEver wondered where a data point came from? Ever been looking through some Tables, Figures and Listings (TFLs) and thought 'I wonder how this number came to be here?'. Chances are you are wondering about the traceability through your data collection, management, and reporting process. Where do you start tracing the data? Where do you finish? How am I going to trace this data effectively? This paper looks into the 'breadcrumb trail' through the data management and reporting cycle of clinical trials. Is there a simple solution out there to manage the traceability of the data in your trial? What will you do when the FDA come knocking and want to see the links through the steps in your process? These questions will soon be answered.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126986140","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
Preparing an eSubmission based on multiple trials, some of which are ongoing — challenges for statistical programming 准备一个基于多个试验的电子提交，其中一些是正在进行的统计程序的挑战
Pharmaceutical Programming Pub Date : 2011-12-01 DOI: 10.1179/175709311X13141790413200
Åsa Carlsheimer
{"title":"Preparing an eSubmission based on multiple trials, some of which are ongoing — challenges for statistical programming","authors":"Åsa Carlsheimer","doi":"10.1179/175709311X13141790413200","DOIUrl":"https://doi.org/10.1179/175709311X13141790413200","url":null,"abstract":"AbstractPreparing for an eSubmission based on multiple trials, some of which are ongoing, is a challenging task for statistical programmers. Having Analysis Data Model (ADaM) standards in place and maintaining a pooled data repository will facilitate the submission work on the data side. However, generating more than 1100 tables and figures for the Integrated Summary of Safety and Efficacy, involving a large team of biostatisticians and statistical programmers (in-house and off-shore), requires careful planning that includes preliminary discussions on consistency across programs. The purpose of this paper is to share experiences and provide some advice for statistical programmers to consider in future submission work.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"49 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123746802","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
Different methods of calculating body sway area 计算身体摇摆面积的不同方法
Pharmaceutical Programming Pub Date : 2011-12-01 DOI: 10.1179/175709311X13166801334271
Thomas Wollseifen
{"title":"Different methods of calculating body sway area","authors":"Thomas Wollseifen","doi":"10.1179/175709311X13166801334271","DOIUrl":"https://doi.org/10.1179/175709311X13166801334271","url":null,"abstract":"Abstract Posturography is used to assess the steadiness of the human body by measuring the movement of the centre of pressure of a standing subject on a force platform (stabilometry). This paper presents three different methods of calculating the centre of pressure trajectory. The first method ('Convex hull') is characterized by the area enclosed by the path of movement (body sway area), approximated by the area of a convex hull. PROC G3GRID is applied for the triangulation of the data points necessary for calculating the convex hull. This approach is compared with the second and most common procedure ('principal component analysis, PCA) which calculates an ellipse enclosing the sample points. PROC PRINCOMP is used to calculate the eigenvectors that represent the derived ellipse of the PCA. A third approach used in clinical studies ('Mean of Circle Areas') calculates the body sway area by summarizing the mean of the circle areas defined by the sample points and their distance to the point of origin. Simul...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131113635","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: 25
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