Journal: Journal of Pharmacy Research

Article Id: JPRS-PCS-00002040
Title: Phase zero clinical trials: A new era in regulatory approach
Category: Pharmaceutics
Section: Review Article
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    Microdosing or phase zero clinical trial is a breakthrough in drug development, where subtherapeutic dosage of various investigational products is administered under necessary safety condition to minimal number of volunteers to obtain an early pharmacokinetic profile of the product. It is an important bioanlaytical tool which benefits the patients as well as the pharmaceutical industry by bringing out new effective molecules faster and reducing the attrition rates at later clinical trial phase. Microdosing appears as a new concept in the toolbox of the drug development activity. It appears that microdosing strategy could complete standard animal to human scaling redefining the exiting concept of phase one clinical research. In future, when research methods and technology involved in phase zero studies become more sophisticated, human microdosing may be applied to a number of drugs developed subsequently. The drug and dose of the trial too small and reliable biomarkers are too thin on the ground despite great sum of money being spent to find and validate them. Phase zero clinical trials can decrease the cost and time and could improve the process of drug development in future. This review emphasis the development and impact of phase zero trial in clinical research.

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    Author(s) Name:

    Y. K.Divya, V. Balamuralidhara*, M. P. Venkatesh

    Affiliation(s) Name:

    Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru - 570 015, Karnataka, India

    *Corresponding author:V. Balamuralidhara,Department of Pharmaceutics, JSS College of Pharmacy, Jagadguru Sri Shivarathreeshwara University, Mysuru - 570 015, Karnataka, India

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    Y. K.Divya, V. Balamuralidhara*, M. P. Venkatesh

    Title:Phase zero clinical trials: A new era in regulatory approach
    Journal:Journal of Pharmacy Research
    Vol(issue):12 (March)
    Page No: (414-419)
  • Experimental Methods Keywords

    Methodology:Microdosing or phase one and zero clinical trial
    Research Materials:Investigational new drug


Clinical trials Investigational new drug Microdosing Phase 1 Phase zero

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