• Corpus ID: 15031559

IMPACT OF PHASE ZERO TRIALS (MICRO-DOSING) IN CLINICAL TRIAL RESEARCH

@inproceedings{Vijayaraghavan2010IMPACTOP,
  title={IMPACT OF PHASE ZERO TRIALS (MICRO-DOSING) IN CLINICAL TRIAL RESEARCH},
  author={Ravikumar Vijayaraghavan and G. Ramesh Kumar},
  year={2010}
}
Currently, pre-clinical trials using animal models, cell culture methods and bio-informatics takes up to 18 months and the typical development for investigational new drugs takes between ten to fifteen years and associated with high cost and low rate of approval. Phase 0 trials are attractive approach and in future would require only few pre- clinical studies, phase I trial and a reduced amount of the investigational new experimental drug on human. FDA supports the conduct of phase 0 trials in… 
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8 Citations
Background Citations
1
Methods Citations
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8 Citations

HUMAN MICRO DOSING STUDIES (PHASE 0): A NOVEL APPROACH IN CLINICAL RESEARCH

The concept of micro dosing has evolved over the last decade from merely pharmacokinetic assessment to wider perspectives like drug - drug, drug - food interactions, bioavailability, oncology, metabolic profiling and use in vulnerable populations etc.

A Review on: Phase ‘0’ Clinical Trials or Exploratory Investigational New Drug

This guidance is intended to clarify what preclinical and clinical approaches, as well as chemistry, manufacturing, and controls information, should be considered when planning exploratory studies in humans under an IND application.

Microdosing: An Emerging Tool for Drug Development

A microdose study is one of a suit of exploratory studies intended to be conducted in early phase-I that involve limited human exposure, have no therapeutic intent and are not intended to examine clinical tolerability.

A Review on Microdosing: Reduction in Cost & Time

In microdosing, extremely low, nonpharmacologically active doses of a drug are used to give the agent’s pharmacokinetic profile in humans to explore clinical characteristics of a candidate agent in a short duration of time.

CLINICAL DATA MANAGEMENT IMPORTANCE IN CLINICAL RESEARCH

The study concluded that data management tools play a key role in the clinical trial and well-designed CRFs reduces the errors and save the time of the clinical trials and facilitates the drug discovery and development.

Phase 0 clinical trials: towards a more complete ethics critique

An ethics critique is proposed, based not on the usual concept of benefit, but on the means–end relation, and placed within an ethic of science derived from the practice of science.

Phase zero trials: a novel approach in drug development process

Although studies are yet to be done for phase 0 trial, it can be recognized that phase 0 trials would provide an opportunity to generate essential human PK and PD data much earlier in a drug development process, which could be a major advantage in design and decision making for further clinical development of an agent.

Practice Association of Pharmaceutical Teachers of India Phase-0 : A General Overview

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