Review Articles

2018  |  Vol: 4(5)  |  Issue: 5 (September- October)  |  https://doi.org/10.31024/ajpp.2018.4.5.4
Role of preclinical pharmacokinetics in New Chemical Entity (NCE) development: A review

Sakshi Negi*, Ashutosh Badola*

Division of Pharmaceutical Sciences, Shri Guru Ram Rai Institute of Technology and Sciences, Patel Nagar, Dehradun-248001, India

*Address for Corresponding Author

Sakshi Negi

Division of Pharmaceutical Sciences, Shri Guru Ram Rai Institute Of Technology And Sciences, Patel Nagar, Dehradun-248001, India.

Abstract

The cost of bringing new chemical entity (NCE) is very expensive and long process and the chances of failure during clinical trials are very high. Inadequate pharmacokinetic data is the major problem and failure of new drug during clinical phase therefore in order to decrease drug failure rates preclinical studies such as in vitro and in vivo pharmacokinetic studies are being conducted. At present, most pharmaceutical companies perform in vitro and in vivo studies together with in silico prediction softwares. The data obtained during preclinical phase helps in eliminating weaker candidate and reduce attrition rate. The aim of this review is to focus on various methods employed during preclinical phase.

Keywords: preclinical, in vitro, in vivo research, pharmacokinetics, new chemical entity

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