To accomplish this, I have teamed up with two of the industry’s leading experts on statistical analysis and the validation of rapid microbiological methods: Edwin R. van den Heuvel, PhD (Eindhoven University of Technology) and David Roesti, PhD (Novartis Pharmaceuticals).
Our paper, The Role of Statistical Analysis in Validating Rapid Microbiological Methods, has recently been published in this month’s European Pharmaceutical Review. Clicking on the publication title (above) will give you online access to the paper (this is free to view but you may need to sign up for access). Alternatively, please copy and past the following address into your web browser:
This comprehensive article discusses the concepts of statistics and hypothesis testing, including:
- How to formulate a null and alternate hypotheses as it relates to rapid method validation
- Identifing the appropriate statistical test
- How to calculate a p-value
- Comparing the p-value with a chosen alpha level