Statistical Data Analysis

STABILITY SYSTEM has the best and most-extensive analysis tools in the market.

There is no need to learn another statistics program. All the tools are built into STABILITY SYSTEM. No exporting of data is required! (although you can export to Excel or FDA SAS input files)

Feature  Description 
Expiry dating calculation Calculate the expiry dating period using the zero-, first-, or second-order kinetics. The least-squares regression analysis method is used.

Statistical method used conforms with FDA and ICH stability guidelines. Click here for a sample expiry graph and report.
Graphing For viewing on the screen or hardcopies for report writing. Click here for examples.
Arrhenius treatment Process accelerated stability data using the Arrhenius equation. Click here for a sample Arrhenius graph and report.
Incorporate QC release data in expiry dating calculation The absolute time zero data refers to those stability data that are generated when the product is manufactured. The absolute time zero data may be generated before the actual start date of the stability study. You can save these absolute time zero data in the database and they can be used in the data analysis.  
Poolability test - ANCOVA Statistically compare multiple regression lines. The results can be used to determine if the data sets from different lots can be pooled together. ANCOVA analysis according to ICH Q1E is available.
Pool data electronically Pool stability data from different files. No data reentry is required. Pooled data file can be processed by most Data Analysis functions. 
Perform regression-on-the-fly while viewing stability file If the regression-on-the-fly facility for the selected test is activated, a least-squares regression based on zero kinetics is performed when feasible. A separate window is used to display the graph from this regression. Click here for an example.
Use existing data for expiry dating simulation for projection Calculate the expiry dating periods under a variety of simulation conditions using existing stability data in the database. Allows the users to determine:
  1. the amount of overage required to achieve a predetermined expiry dating period
  2. the lowest release specification that still supports the approved expiry dating period
  3. a shorter expiry dating period when the QC release data is lower than the acceptable release specification.
Kinetic theory and statistical methods The User Manual contains a section called A Crash Course on Chemical Kinetics and Statistical Data Treatment that discloses all statistical methods used in STABILITY SYSTEM. It also discusses chemical kinetic theory. A great way to learn what you always wanted to learn in these subjects.

Excerpts from this material are available on this web site. These are great learning materials to enhance your stability skill.
  1. Simple Reactions
  2. Arrhenius Equation
  3. Regression Analysis
No need to export data to another statistics program If you do need to export the data, the data can be exported as CSV file which you can load into a spreadsheet program (such as Excel) that typically provides some simple statistical methods, including regression. 
Interface with FDA SAS program Create ASCII data files which can be processed by the FDA SAS Drug Formulation Stability Program. This program was developed by the Division of Biometrics at the Center for Drug Evaluation and Research, a section of Food and Drug Administration. 
Data reduced to a format that is easily understood by pharmaceutical scientists STABILITY SYSTEM does all the hard work for you and delivers the answers in formats that are easy to understand without statistics training. 
Data analysis supports the zero, first and second kinetic orders Curious about the kinetic orders? Click here to learn more.