Abstract

Bioassays are methods employed to estimate the effect of a given substance in living matter, and therefore they are frequently used in the pharmaceutical industry. Bioassays are a vital part of the overall assessment of a product’s efficacy, safety, lotto lot consistency and stability. These more complex entities can challenge the developer of the bioassay to generate potency assay that truly mimic the mechanisms of activity. Strategies and challenges for bioassays for insulin will be discussed during this review. The European Pharmacopeia Commission now supports a program of research to replace animal-based testing, and to delete the requirement for animal testing to assess the efficiencies of insulin. Although insulin (51 amino acids, molecular mass of 5800) are now regarded as chemical drugs, dose in milligrams, and approved for use in human without the need for any form of bioassay. The European Pharmacopeia does not require such an in vivo bioidentity test. However, the animal testing is still required in United States Pharmacopeia to assay the efficiency of insulin. The United States Pharmacopeia mandates an animal based assay in rabbits in its chapter "Insulin Assays" for the potency evaluation of insulin and insulin analogs to be imported to the US. There are argent needs to review and discuss this issue