Katherine Dunnington

Celerion (United States) United States of America

Dr. Katherine 'Shelly” Dunnington resides and works in the Midwest United States in the state of Kansas. She is a pharmacokineticist with training in pharmaceutical science and cellular or molecular biology and originally was a practicing pharmacist both in hospital and retail settings. She is currently a senior principal scientist in the Data Management and Biometrics department at Celerion, a pharmaceutical contract research organization. With 21 years in contract research, Dr. Dunnington has many roles in her current position, including training or mentoring scientists; consulting on clinical study design and conduct; analysis, interpretation, and reporting of clinical PK/PD and cardiac safety data; and software validation. Dr. Dunnington holds both a bachelor\'s degree in pharmacy and an interdisciplinary Ph.D. from the University of Missouri-Kansas City.

1books edited

1chapters authored

Latest work with IntechOpen by Katherine Dunnington

Drug metabolism comprises the identification, characterization, and quantification of the chemicals or compounds produced in an animal or human upon administration of a drug. Research practices not only require the chemical structure but also aim to determine the pharmacological activities and/or toxicity of these compounds. This is first performed in animals, as studies attempt to identify and quantify metabolites, and later in humans, with care to further characterize metabolites that are either unique to or produced disproportionately in humans compared to animals. Characterization includes the determination of enzyme systems or other biological mechanisms that produce each identified metabolite; this information is used to predict potential drug-drug interactions with other compounds that increase or decrease metabolite formation and sources of biological variability in response or toxicity with varying patient genetics, which affect CYP isoform expression. This book’s purpose is to provide some understanding of the biology and current technology applied in the field of drug metabolism.

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Drug Metabolism

Edited by Katherine Dunnington

Chapters authored

Application of Pharmacokinetics in Early Drug Development

By Katherine Dunnington, Natacha Benrimoh, Christine Brandquist, Nadia Cardillo-Marricco, Mike Di Spirito and Julie Grenier

The intention of this chapter is to provide an overview of how pharmacokinetics, also termed PK, is applied in early drug development. While there are many readily available printed and web accessible sources on pharmacokinetics, its technical terms, model definitions, and calculation methods; how the science of pharmacokinetics is used in specific situations, namely early drug development are not as readily covered. In fact, the reader will see that the continual theme in this chapter is that a small amount of pharmacokinetic data and its interpretation in the first nonclinical or clinical study is important in obtaining additional pharmacokinetic, safety, and efficacy information for the next study. The role of PK in the three phases of clinical drug development is described as well as the types of early Phase 1 studies where PK determinations are important. The PK measurements in the first in humans study (FIH) provide a tentative confirmation of safety at the measured exposures from the tested dose levels. Even if exposures from a given dose change due to food-effects, drug–drug interaction, drug-disease interactions, or use in a special population, safety can be assessed by bridging these results to the initial safety or efficacy exposures.

Part of the book: Pharmacokinetics and Adverse Effects of Drugs

Katherine Dunnington

Latest work with IntechOpen by Katherine Dunnington

Drug Metabolism

Chapters authored

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