In this approach, live animals that are capable of expressing the desired biological effect in man are employed to ascertain that the biopharmaceutical sample of interest has statistically significant relative potency when compared with that of the reference standard. Whole animal bioassays are generally used only because an alternative in vitro or biochemical assay has not been demonstrated to be predictive of the activity of the drug of interest. Live animal assays are difficult to validate requiring large numbers of animals per dose/treatment group due to poor animal-to-animal reproducibility. Precision in the range of 30 - 100 % RSD are not uncommon. In addition, the validation efforts required are expensive and require extraordinary lengths of time as each bioassay requires several days or several weeks to detect a measurable biological effect after dosing with the drug. Although validation of such assays is achievable as evidenced by the whole animal bioassays that have been established for biotechnologically derived products such as human growth hormone , and human insulin , it is highly desirable to develop alternative systems for establishing the potency of a pharmaceutical protein.
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