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Pharmacokinetic and Pharmacodynamic Assessment of Novel and Biosimilar Insulins

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Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease

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Abstract

Technological advances in insulin therapy have resulted in a wide and ever-expanding range of rapid-acting and long-duration insulins. Development of novel insulins is founded on considerations of pharmacokinetics and pharmacodynamics. Demonstration of clinical safety and efficacy is required as a novel insulin progresses from preclinical to clinical development. The euglycemic clamp technique is the method of choice for determining time-action profiles of new insulins. Data from glucose clamp studies are required by regulatory authorities. Regulatory requirements for approval of biosimilar insulins include rigorous evaluation of the pharmacodynamic and immunogenic properties of these insulins; the euglycemic clamp is central to pharmacodynamic evaluation of biosimilar insulins.

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    Andrew J. Krentz, Christian Weyer & Marcus Hompesch

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    Christian Weyer

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    Marcus Hompesch

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Krentz, A.J., Weyer, C., Hompesch, M. (2019). Pharmacokinetic and Pharmacodynamic Assessment of Novel and Biosimilar Insulins. In: Krentz, A., Weyer, C., Hompesch, M. (eds) Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease. Springer, Cham. https://doi.org/10.1007/978-3-030-11748-1_3

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