Abstract

A REVIEW ON MICRODOSING (PHASE ZERO) - NEEDS, DEVELOPMENT AND ITS APPLICATION

Sharath H. D.*, Prakash Goudanvar, Vedamurthy Joshi, Thejas K. S., Venugopal N.

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Abstract

The lengthy, expensive, and complex drug development process necessitates years of testing before a new treatment can be introduced to the market. In the 'toolbox' of drug development, the microdosing methodology is described as a new and valuable 'tool' that bridges lead optimisation and early clinical development. In order to define the pharmacokinetic profile of medication in people and examine drugdrug interactions, the idea of microdosing has been expanded. Phase 0 is restricted to the fundamental components—therapeutic efficacy, safety, dose escalation, and tolerance—that make up phase I. Phase 0 investigations eliminate drugs that don't meet the fundamental criteria, making the medication development process quick and fruitful. Phase 0 in clinical trials can be a helpful metric to assess the safety of a medicine at a subtherapeutic dose, the fundamental standards of clinical studies carried out under an exploratory IND, and to address some typical mistakes with phase 0 trials. This review article provides information on microdosing from its inception to its current practical use.

Keywords: Phase0, Microdosing. Drug development, Pharmacokinetics.