Biological Potency Assays are Key to Assessing Product Consistency
The determination of biological potency plays a key role in the development, registration, and control of biological and biotechnology-derived products. Advances in science have affected both the way these assays are carried out experimentally and how they are analyzed statistically. During the past several years, the United States Pharmacopeial Convention has focused on public standards to modernize and expand the bioassay requirements in the United States Pharmacopeia. This work has been carried out in several expert committees of the Council of Experts, USP's standards-setting body composed of volunteer scientists from many countries of the world. [more...]
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