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The Relevance of Clinical Pharmacology Studies of Basal Insulins to Primary Care
Pharmacokinetic (PK) and pharmacodynamic (PD) properties of drugs form the basis for the development of drugs used in everyday clinical practice, such as commonly used insulin products. PK measures the concentration of a drug in the body, and reflects the rates and amounts absorbed and processed. PD is the biologic effect of a drug in the body, including the time-course of when the biologic effect starts, peaks, and ends. While the determination of PK/PD parameters is important and foundational for the development of different insulin products, studies are often complex and can be difficult to translate into real-world clinical practice. In this round-table the speakers discuss PK/PD concepts, focusing on differentiation of basal insulin analogs and their use in individualized diabetes therapy.
This peer-reviewed publication was developed in adherence with Good Publication Practice (GPP3) guidelines. All authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship and have disclosed all potential conflicts of interest.
Video 1 of 3: Overview of PK/PD: Definitions and Methods for Establishing Pharmacologic Parameters
Video 2 of 3: How PK/PD Impacts Drug Development
Video 3 of 3: How PK/PD Data Translate into Clinical Practice
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Video 1 of 3: Overview of PK/PD: Definitions and Methods for Establishing Pharmacologic Parameters
About the Panel
DISCLOSURES
- Dr. Meneghini is on the advisory panels for Intarcia and Novo Nordisk; a consultant for Novo Nordisk and Sanofi.
- Dr. Reid has been a speaker/consultant for Boehringer Ingelheim, Janssen, Novo Nordisk, and Sanofi-Aventis.
- Dr. White is an advisory board member for Novo Nordisk and Sanofi US, Inc.
ACKNOWLEDGEMENTS
- This research was funded by Sanofi US, Inc.
- The authors received writing/editorial support in the preparation of this manuscript provided by Rasilaben Vaghjiani, PhD, of Excerpta Medica, funded by Sanofi US, Inc.
- The speakers would like to thank Marcus Hompesch, MD, for his contribution to this roundtable.