The Discovery Of New Drug Without Involving Human Subjects

1782 Words Mar 12th, 2016 8 Pages
Non clinical Studies
The discovery of new drug without involving human subjects is called as non clinical studies. Goals of non-clinical testing of Biologics are: characterization of potential adverse drug effects, identify end organ toxicities, identify reversibility of toxicity , characterization of pharmacokinetic profile, characterization of beneficial pharmacodynamic effects -proof of principle , guideline for safe use in human clinical studied determination of a safe and reasonable starting dose and provide monitoring guidelines for the clinical study, provide sufficient clinical data to conclude that there no unreasonable exposure of risks to the patients.
Non clinical research has been conducted in two phases in compliance with Good Laboratory Practice, 21 CFR 58 and ICH S6 guidance (Serabian et al,. 2009).1.invitro –test tube experiments and 2.invivo-animal models (Lynch et al,. 20019).
For in vitro testing, targets will be known or unknown. The non clinical studies normally performed in living cells, and in computational models with a lead compounds which go through a series of tests to provide a preliminary assessment of safety and ending with definitive clinical trials. Before starting non clinical studies, it is very important to recognize any relevant information like the clinical sign, route of administration, and dosing procedure.
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