Training

Training & Statistical Awareness

To build a common knowledge base for your teams and help your employees to exchange with each other. Hyphen is referenced Datadock.

Some example of courses

  • Statistical analysis of long-term stability data
  • How to identify Out-Of-Trend (OOT) results in stability and at release
  • Design of Experiment (DoE) in the Quality by Design (QbD) – ICH Q8 approach
  • Statistical analysis and interpretation of dissolution tests results
  • Statistical analysis and interpretation of analytical method validation
  • Design and analysis of results from analytical method transfer
  • Equivalence approach for bioassay analysis
  • Use of ROC curves to define diagnosis criteria
  • Statistical tools in production (Statistical Process Control/SPC)
  • Statistical tools for laboratory

Some example of courses

  • Statistical analysis of long-term stability data
  • How to identify Out-Of-Trend (OOT) results in stability and at release
  • Design of Experiment (DoE) in the Quality by Design (QbD) – ICH Q8 approach
  • Statistical analysis and interpretation of dissolution tests results
  • Statistical analysis and interpretation of analytical method validation
  • Design and analysis of results from analytical method transfer
  • Equivalence approach for bioassay analysis
  • Use of ROC curves to define diagnosis criteria
  • Statistical tools in production (Statistical Process Control/SPC)
  • Statistical tools for laboratory

Customized training

Depending on your needs, courses are organized within the company or outside of it.

Training sessions are designed to get a better undestanding and a better use of statistical tools.

Our experience in life science research and early stage drug development allows us to gain insights into specific issues faced by the pharmaceutical industry.

We encourage you to contact us to build a training session that best fits your needs.

Teaching approach

Hyphen designs training sessions tailored to your context. Our courses emphasize the principle of statistical approach and increase self-sufficiency in the use and interpretation of classical methods.

The Hyphen team draws on the experience gained in the training field to offer adapted teaching materials:

  • interactive modules
  • results oriented towards interpretation
  • application on real data

The statistical concepts raised during the training are presented through various practical exercises or operational case studies.