| Popis: |
This chapter deals with the validation of assay and impurities methods for “small molecules.” The general principles described here are also generally applicable to “large molecules”; however, more than one test is usually necessary to characterize the potency of macromolecules because their potency is dependent not only on concentration but also on other factors such as three-dimensional structure and posttranslational modifications. The validation of methods to assess the potency and purity of macromolecules is discussed in detail in the later chapters. |
