8DECEMBER - JANUARYTECH OUTLOOKIN MY OPINIONIMPLEMENTING DOSE-EXPOSURE-RESPONSE INFORMATION AND MODERN TOOLS IN DRUG DISCOVERY?By Riikka Oksala, Director, Head of DMPK and Safety Sciences, R&D, OrionDrug Metabolism and Pharmacokinetics (DMPK) plays a critical role in the drug development by helping to ensure the safety and efficacy of new drugs. DMPK is a multidisciplinary branch of science that studies the behavior of drug candidates in the body, including their absorption, distribution, metabolism, and elimination. In the drug discovery process, DMPK information helps to identify the most promising drug candidates and to optimize their formulation and dosing regimen. This information is critical for the design and execution of preclinical and clinical trials, as well as for the eventual approval of new drugs by regulatory agencies. In drug discovery, the goal is to find a drug that is both safe and effective. Safety is assessed by determining the exposure levels of the drug causing adverse events, while efficacy is evaluated by determining the minimum effective exposure. To achieve this, scientists must understand the dose-exposure-response relationship for a particular drug. This information is used to guide the development of the drug from early discovery to clinical trials.Dose-exposure-response is a critical concept in drug discovery, as it describes the relationship between the amount of drug administered, the level of the drug in the body (exposure), and the resulting biological response (effect). In simple terms, it explains how a drug works in the body, and how the dose and exposure level impact the therapeutic effect. The dose-exposure-response relationship is influenced by several factors, including the pharmacokinetics (PK), the pharmacodynamics (PD) and the safety. PK describe how the drug is absorbed, distributed, metabolized, and eliminated from the body. The PD define how the drug works in its target. Therefore, target protein, the mechanism of action,
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