Preclinical Animal and Nonclinical Study

Preclinical are the studies occurring prior to clinical testing. Nonclinical are the studies not related to, concerned or not involving, with the treatment of living patients as well as direct observation. Preclinical Animal Non clinical Study are the laboratory test of new drug substance or medical devices usually done animals, to see whether the treatment really works and if it is safe to use on humans. Preclinical Animal Non clinical Study studies terminology is interchangeable. Nonclinical studies are typically considered as the group of in vitro and animal studies that are conducted from when the preclinical drug candidate is selected for development until the product is approved for marketing. The term preclinical is generally used to describe the same studies but identifying those conducted before the first clinical trial. Nonclinical studies include ADME (absorption, distribution, metabolism, and excretion), pharmacology, safety pharmacology, genotoxicity, toxicity, carcinogenicity, and/or developmental toxicity of the drug. Preclinical and Non-Clinical studies are generally performed on rodents like mouse, rat, guinea pig, hamster and rabbit. After the results are successful, experiments are performed on larger animals like cat, dog, monkey etc. Preclinical and Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. Preclinical and Non-clinical studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. During the Preclinical and Non-clinical studies phase, the candidate compound should meet non-medical objectives, including defining the intellectual property rights and making enough medicinal product available for clinical trials. The Preclinical and Non-clinical studies of a medicine is complex and regulatory-driven.