Microdosing – An unprecedented move
Journal Title: International Journal of Research in Pharmacology & Pharmacotherapeutics (IJRPP) - Year 2015, Vol 4, Issue 4
Abstract
MICRODOSING OR PHASE 0 An early phase of a trial has a vital role in the unprecedented expansion of the clinical trial sector and the drug development process in the emerging era. Micro dosing as the name reflects its definition, in this phase, healthy volunteers are administered a drug at doses of 100 micrograms or 1/100th of a normal dose, whichever is lesser. At such low doses volunteers are not exposed to drug toxicity but still drug effect can be determined because the drug is bound to a radiolig and which makes it easier for the detection of even minute amount of dosage .By possible powerful detection techniques like accelerator mass spectroscopy and positron emission tomography samples are drawn and pharmacokinetics as well as pharmacodynamics can be studied .Thus it is helpful for both the patients and the pharmaceutical organisations as this stands as an attractive approach that requires only few preclinical studies , phase 1 trial and a reduced amount of candidate drug on human beings . Microdosing has a promising role in the study of drug- drug interaction besides pharmacokinetic aspects.
Authors and Affiliations
Agnesh. Valluri
Keywords
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