Insulin lispro is a rapid-acting insulin analog that was first introduced in 1996 to treat people with diabetes. For an LBA (ligand binding assay) to qualify as a PK assay, several requirements for assay design, as well as analytical performance, are specified in industry guidelines. For insulin lispro, an easy-to-use, high quality PK assay that can meet the pharmaceutical industry requirements for multiple phases of drug development is needed. In addition, differentiating lispro not only from other rapid- and long-acting insulin analogs, but also from native insulin, is a need that demands careful method development.
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