A NOVEL APPROACH to Transdermal System Evaluation

 
logo
eBulletin   |  March 2015  
A Novel Approach to Transdermal System Evaluation
 

 

Sponsors now have an alternative solution to assess transdermal patch adhesion. Algorithme Pharma's proprietary tools, combined with ImageJ software, a public domain image processing program, have further improved the adhesion analysis process. It's a novel technological approach. With an increase in patch adherence percentages driven by method accuracy and precision, as well as a streamlined calculation process, and potential grid pattern variations equalization,
Sponsors benefit from:

 

The ability to precisely measure patch detachment areas for potentially difficult patch sizes or shapes, i.e. square, round, small or large patches and normalizing the accuracy between patches of different sizes being compared, in a cross-over trial.

 

Automated features of scaling, area labelling, percent adherence calculation and assessment file saving, added to the native Open-Source software for increased efficiency, accuracy and integrity of results.

 

Reduced variability with on-the-floor assessment of the patch and subsequent precise evaluation of actual adhesion by a central reader.

 

 

The ImageJ software, distributed by the National Institutes of Health (NIH), has undergone a complete validation cycle, including testing for measurement accuracy and calculations, as well as intra and inter operator accuracy and precision, ensuring consistent and reliable results throughout the study.

Comparative analysis of manual versus imaging assessment, demonstrates that the electronic process is comparable to the paper process. Statistical analysis of the results support the reliability of the methodology based on the relative correlation between manual and image-generated adhesion percentages.

Algorithme Pharma is positioned to accommodate client needs for methodology assessment, and is proactively engaged for potential regulatory shifts for study design and data submission expectations. With the similarities in the two techniques, manual assessment can be supplemented with the imaging capabilities, for additional analyses in the study data.

 
Contact us for information >>
 
 
 
For more information, please contact us:
 
450 973-6077 | 888 267-7449 | contact@algopharm.com
 
 
 
 
©2015 All Rights Reserved, Algorithme Pharma inc., 2015