Multivariate data analysis easily retrieves insight from a wealth of data - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Multivariate data analysis easily retrieves insight from a wealth of data


Pharmaceutical Technology Europe
Volume 22, Issue 2

Traditionally, studies are performed and analysed following a univariate (one variable at a time) approach. The big advantage of this is that simple 2D plots can be used to assess cause and effect relationships, and the corresponding statistics are straightforward too. The production environment, however, is never univariate, and interactions between parameters should be expected. In the pharmaceutical arena, this situation has been well recognised — guidelines such as ICH Q8 on Pharmaceutical Development and ICH Q10 on Pharmaceutical Quality System explicatively mention the multidimensional design space in which product performance should be tested to assure quality.1,2 In this context, trend analyses of the manufacturing process performance and its products have been mentioned as an important tool for innovation and continuous improvements.3 A potential complicating factor with multidimensional data, however, is that it is not possible to visually inspect such data and so other ways are needed to represent the results.


Matthias Tunger/Getty Images
This is where multivariate statistics can help; it facilitates the powerful analysis of multidimensional data and, simultaneously, amasses knowledge at a single glance.

From dull tables to essential information

For a process running for several years, a wealth of data is usually stored in databases containing continuously measured data and routine-based quality control (QC) data, but it is extremely difficult to obtain useful information from such an intimidating amount of numbers and other data. Multivariate data analysis (MVA) is an approach that converts data into knowledge by using data exploration techniques, without narrowing down solely on allegedly unknown aspects. Representing this knowledge for human interpretation can be done visually.

Historical data can be analysed using MVA to learn from the past, which can be useful to solve current problems, avoid future ones or to make a validation study of a similar production process or compound quicker and cheaper. Analysing historical data can also avoid, or shorten, new studies, which are often expensive. When visualised properly, extended sets of data, such as dull and perhaps confusing tables, can be changed into spatial representations that clearly depict essential information that is not visible a-priori. The methods are widely applicable and can be used, for instance, for measuring the quality and authenticity of samples, or for monitoring a production process.

MVA for a pharmaceutical quality system




MVA helps to transfer data into knowledge, which is very useful in a pharmaceutical quality system, as mentioned in ICH Q10. In this scenario, the analysis of historical data can play an important role: these data are already available and very often contain useful information that can be used for innovation and quality improvement. As this has not yet been commonly recognised, the following case study will demonstrate its advantage.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
28%
Oversee medical treatment of patients in the US.
9%
Provide treatment for patients globally.
9%
All of the above.
41%
No government involvement in patient treatment or drug development.
13%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology Europe,
Click here