Clinical Pharmacology & Biopharmaceutics
Open Access

Microdosing in Early-Phase Clinical Trials: Enhancing Drug Development with Minimal Risk and Optimized Safety Profiling

N. Malhotra Singh^*

ART Centre, Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, India

Received Date: Nov 01, 2024 / Published Date: Nov 29, 2024

Citation: Malhotra Singh N (2024) Microdosing in Early-Phase Clinical Trials: Enhancing Drug Development with Minimal Risk and Optimized Safety Profiling Clin Pharmacol Biopharm, 13: 513.

Copyright: © 2024 Malhotra Singh N. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Microdosing in early-phase clinical trials offers a promising approach to drug development by administering subtherapeutic doses of a drug to human participants. This technique aims to gather critical pharmacokinetic and pharmacodynamic data while minimizing the risks associated with conventional dosing strategies. Microdosing allows for the exploration of a drug's absorption, distribution, metabolism, and excretion (ADME) properties in humans early in the development process, significantly enhancing safety profiling. By using non-toxic, minimal doses, microdosing aids in identifying the most appropriate therapeutic dose, accelerating drug development, and ensuring patient safety. This paper reviews the potential of microdosing as a tool in early-phase trials, its benefits, limitations, and the regulatory considerations that support its use. The adoption of microdosing strategies in drug development could potentially reduce costs, improve efficiency, and streamline the clinical trial process.