Stability Analysis With Alteryx Designer

A Major Use Case in the Pharmaceutical Industry 

In phar­maceu­ti­cal qua­li­ty assu­rance, sta­bi­li­ty ana­ly­sis is a cri­ti­cal pro­cess for esti­mat­ing the shelf life of pro­ducts. While Alte­ryx Desi­gner offers a com­pre­hen­si­ve suite of basic sta­tis­ti­cal tools, its seam­less inte­gra­ti­on capa­bi­li­ties with open-source lan­guages like Python and R enable inte­gra­ti­on of advan­ced ana­ly­ses like ANOVA (Ana­ly­sis of Vari­ance) or ANCOVA (Ana­ly­sis of Cova­ri­ance), which are essen­ti­al for sta­bi­li­ty stu­dies. This way Alte­ryx beco­mes a robust plat­form for per­forming the­se com­plex cal­cu­la­ti­ons.

Leveraging Alteryx for Stability Analysis

Sta­bi­li­ty stu­dies rely hea­vi­ly on sta­tis­ti­cal methods such as ANOVA or ANCOVA, which allow for the ana­ly­sis of pro­duct degra­da­ti­on over time across mul­ti­ple bat­ches. The­se methods are com­pu­ta­tio­nal­ly inten­si­ve, as they requi­re matrix mul­ti­pli­ca­ti­ons, but lan­guages like Python can hand­le the­se ope­ra­ti­ons effi­ci­ent­ly in just a few lines of code.

For shelf life esti­ma­ti­on, an ANCOVA model is often appli­ed to assess the influence of both time (as a cova­ria­te) and batch (as a cate­go­ri­cal varia­ble) on the mea­su­red con­cen­tra­ti­ons of the acti­ve ingre­di­ent. The basic work­flow in Alte­ryx Desi­gner for this use case can be bro­ken down as fol­lows:

1 - Connect to Your Data Sources

Start by inte­gra­ting your sta­bi­li­ty data, which typi­cal­ly includes batch infor­ma­ti­on, time points, and mea­su­red con­cen­tra­ti­ons, into an Alte­ryx work­flow. Alte­ryx Desi­gner offers con­nec­tors to a wide varie­ty of data­ba­ses and file for­mats, making it easy to import this data.

2 - Prepare the Data  

Use Alteryx’s powerful data pre­pa­ra­ti­on tools to cle­an­se and res­truc­tu­re the data­set as requi­red for ana­ly­sis. This step may invol­ve fil­te­ring, impu­ting miss­ing values, and refor­mat­ting the data to ensu­re it is in the cor­rect struc­tu­re for sta­tis­ti­cal ana­ly­sis.

3 - Apply Python for Advanced Statistical Analysis

Once the data is rea­dy, the Python tool in Alte­ryx Desi­gner can be employ­ed to run the ANCOVA model. By uti­li­zing Python libra­ri­es like Pan­das for data mani­pu­la­ti­on, Stats­mo­dels or Sci­Py for sta­tis­ti­cal ana­ly­sis, and Mat­plot­lib for visua­liza­ti­ons, you can easi­ly exe­cu­te com­plex cal­cu­la­ti­ons and visua­li­ze the results. A typi­cal Python code block for ANCOVA might look some­thing like this:

				
					import pandas as pd
import statsmodels.api as sm
from statsmodels.formula.api import ols 
model = ols('Concentration ~ Time + C(Batch)', data=df).fit()
anova_table = sm.stats.anova_lm(model, typ=2)
print(anova_table)

				
			
 4 - Report and Visualize the Results

After run­ning the sta­tis­ti­cal ana­ly­sis, Alte­ryx Designer’s report­ing tools can be used to crea­te dash­boards or export the results to other plat­forms. Whe­ther it’s visua­li­zing trends in pro­duct degra­da­ti­on or gene­ra­ting reports for regu­la­to­ry sub­mis­si­ons, Alte­ryx can hand­le it all.

Conclusion

This use case demons­tra­tes how Alte­ryx Desi­gner can be trans­for­med into a powerful tool for phar­maceu­ti­cal sta­bi­li­ty ana­ly­sis through its inte­gra­ti­on with Python. Alteryx’s fle­xi­bi­li­ty allows users to per­form deep sta­tis­ti­cal ana­ly­ses by lever­aging exter­nal libra­ri­es.

The abili­ty to hand­le com­plex data pre­pa­ra­ti­on, inte­gra­te with open-source tools, and auto­ma­te report­ing makes Alte­ryx a high­ly valuable plat­form in the phar­maceu­ti­cal indus­try. Addi­tio­nal­ly, Alteryx’s vibrant user com­mu­ni­ty pro­vi­des excel­lent sup­port and inno­va­ti­ve ide­as, making it easier to sol­ve com­plex pro­blems.

In sum­ma­ry, Alte­ryx is not just a tool for basic analytics—it’s a plat­form that can be cus­to­mi­zed to meet the spe­cia­li­zed needs of indus­tries like phar­maceu­ti­cals, whe­re pre­cis­i­on and relia­bi­li­ty are para­mount.

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Sasha Shiran­gi (Head of Sales)