Level: Intermediate
Job Function: Analyst / Scientist / Engineer
Industry: Life Sciences
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.
