About this document
Statistics in Small Molecule Validation by Luis Cárdenas is a document available to read on EtoBox.
The document discusses using statistics in validation for a small molecule case study. It provides an example using potency testing of a drug substance, focusing on evaluating the precision and uncertainty of the test method. Precision is assessed using gage R&R studies and intermediate precision experiments. Acceptance criteria for precision are set using decision rules based on the probability of making incorrect conclusions about a sample
- Author
- Luis Cárdenas
- Language
- EN