Quanticate_blog

Subscribe by Email

Your email:

Posts by category

Follow Us

Quanticate CRO Blog

Current Articles | RSS Feed RSS Feed

PK data analysis and reporting: SAS or Phoenix WinNonlin?

  
  
  

 

 pk data analysis 

SAS [1] is regarded as the industry standard for clinical data analysis and reporting; however, Phoenix WinNonlin[2], which is a powerful tool tailored to the specific demands of PK data, is widely accepted as the industry standard for PK data analyses. This widespread separation of responsibilities, and the resultant transfer of data between software applications (and in many cases departments), has the potential to not only cause significant reporting delays, but can also lead to incohesive clinical study reports (CSRs) containing tables, listings and figures (TLFs) derived from various different sources.


Figure 1: Aesthetic differences between SAS and Phoenix WinNonlin outputs

SAS

PK data analysis

WinNonlin

Pharmacokinetic data

SAS

PK Analysis

WinNonlin

PK PD Data

 

Phoenix WinNonlin’s advanced reporting capabilities are very useful when compiling stand-alone PK reports, facilitating rapid illustration of PK data through workflows and templates; however, when results are integrated into a large CSR, it is often preferable to generate TLFs in SAS for consistency with the remainder of the clinical report (e.g. safety and efficacy data).  Devising robust procedures using SAS transport files and CDISC nomenclature enables a readily switch between Phoenix WinNonlin and SAS (not to mention other software packages such as NONMEM[3]) to produce TLFs in a format which is suitable for each individual study’s reporting requirements. Although the main aspect of any PK analysis should be ensuring that the correct approach has been used (e.g. model selection, etc), the presentation of results should not be underestimated; the visual appearance of data plays a key role in facilitating a clear understanding of whether or not key study objectives have been attained. 

Figure 2: Typical PK workflow using SAS and Phoenix WinNonlinPK PD Analysis


So, is it best to use SAS or Phoenix WinNonlin for PK data analysis and reporting?  With some careful forward planning, why not use both? This seamless approach, coupled with a robust catalogue of pre‑defined SAS programs and macros not only removes potential data‑exchange delays, but improves consistency between outputs, augments quality control (QC) procedures and improves reporting timelines. 

References

[1]               SAS Institute Inc.,Cary,NC,USA.

[2]               Pharsight Corporation Inc.,Mountain View,CA,USA.

[3]               ICON Development Solutions,Ellicott City,MD,USA.

 

pkpd2


Comments

Whether SAS and WinNonLin packages mandatory for BA/BE analysis? My understanding is 'no' but usually used for 'regulatory approvals'. Request experts to share experiences with other packages.
Posted @ Wednesday, June 27, 2012 1:53 AM by Anil Arekar
To our knowledge, neither SAS nor WinNonlin are ‘mandatory’ for BA/BE analyses: any software package could be used (or even a calculator), as long as the correct PK methods and statistical tests are applied; SAS and WinNonlin are specifically designed for the task, and therefore make these calculations a little easier. There are a significant number of alternative PK packages available too; a relatively comprehensive list can be found here: http://www.boomer.org/pkin/soft.html. Our understanding is that SAS and WinNonlin and commonly used packages used for BA/BE across the pharmaceutical industry. NONMEM and NLME are options for population PK but not necessary for BA/BE. R is less easy to use but has the advantage of being free. Kinetica has similar functionality to WinNonlin. We have limited experience of other packages and therefore cannot comment on their merits. 
 
 
 
It is important to bear in mind that for regulatory submissions, all software packages should be fully validated (in compliance with CFR 21, Part 11); as the validation of each separate system tends to be quite time consuming, this largely explains why we have no experience using packages other than SAS and WinNonlin. 
 
 
 
Finally, from a BA/BE perspective, to ensure that appropriate analysis methods are used I would strongly recommend consulting the following guidance notes:  
 
 
 
EMEA “Guideline on the Investigation of Bioequivalence” (http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf)  
US FDA “Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations” (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf)  
US FDA “Guidance for Industry: Statistical Approaches to Establishing Bioequivalence” (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf)  
US FDA “Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies” (http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126833.pdf)  
Posted @ Wednesday, June 27, 2012 9:46 AM by Statistical Consultancy Team
Thanks for detailed comments. 
Anil Arekar
Posted @ Thursday, June 28, 2012 3:15 AM by Anil Arekar
Post Comment
Name
 *
Email
 *
Website (optional)
Comment
 *

Allowed tags: <a> link, <b> bold, <i> italics