Testing for parallelism is a fundamental requirement for assessing the validity of bioassay data used to calculate relative potency. When a test sample and the reference material are diluted and assayed, the assumption is that their dose response curves have an identical shape. The standard statistical approach to demonstrate that two curves are parallel involves testing the null hypothesis for equality. This article explains why that approach is not appropriate and presents an argument for testing the null hypothesis for a specified difference to statistically ascertain parallelism…
Tag: <span>testing</span>
As advanced analytical techniques become more widely used for product testing, and as more biological products become better characterized, the expectations increase that all biological products will become well characterized. Certainly, the trend is for all regulated products to become better characterized, and for a growing set of analytical methods to attain common usage. As more data is presented in regulatory submissions and reviews, similar data is expected, or desired, in most future product submissions. Furthermore, the techniques being used are opening additional avenues of product testing that regulators may want to see, or that the larger companies could establish as commonly accepted practice…
The use of animal products, such as bovine serum, in the manufacture of biologics is a common practice. The United States’ Code of Federal Regulations, part nine (9CFR), dictates mandatory testing for viruses. In the last few years, we have learned that certain viruses undetected in industry standard tests, like the 9CFR assay, can cause significant contamination of bovine products. Last year in Europe, new guidelines from the Committee for Veterinary Medicinal Products (CVMP), and draft guidelines from the Committee for Proprietary Medicinal Products (CPMP), were published to address testing requirements for bovine serum. The use of these European Guidelines for bovine serum testing broadens the ability to detect viral contamination…