Level: Intermediate

Job Function: Analyst / Scientist / Engineer

**Donald McCormack, JMP Technical Enablement Engineer, SAS**

Statistical analysis of biological assays and tests is commonly carried out in the pharmaceutical and biotechnology industries. It is an important component to regulatory submissions, development of standard operating procedures and maintenance of good manufacturing practices. Standards are frequently employed for carrying out these procedures and in Europe, Section 5.3 of the European Pharmacopoeia (Statistical Analysis of Results of Biological Assays and Tests) – EP 5.3 – is possibly the most often used standard. While EP 5.3 and similar documents are invaluable in providing guidance for performing complex and detailed procedures, there are often drawbacks. EP 5.3 relies on hand calculated values for all statistical estimates which are, unless operationalized via computer algorithm, prone to error. In addition, the formulas provided are not necessarily generalizable to other situations, such as when the design for data collection is unbalanced. The simplifications used in formula development may also lead to inconsistencies in the statistical estimates.

In this presentation JMP will be used to demonstrate how the analyses in EP 5.3 can be carried out quickly, consistently, and accurately. Examples from the document will be used to illustrate this process. Inconsistencies in EP 5.3 will be discussed and alternative methods for analysis will be presented. A JSL script for the calculating of relative potency and its confidence interval will also be demonstrated.