Abstract

REVIEW ON PRECLINICAL AND CLINICAL STUDIES

Nemane Pratiksha Suresh*, Khandagale Sandip Suresh, Kshirsagar Priyanka Vitthal, Khose Arati and Nalwade Omkar Bappasaheb

ABSTRACT

The drug development process is usually divided into three main phases, the first phase of discovery is preclinical development clinical research. The boundary between preclinical development and clinical trials is sharply defined by the investigational new drug (IND). The adage initiated at the end is particularly suitable for preclinical development, as (IND) supports the design of plant clinical trials moving from Discovery to the preclinical development continuum, and pharmacological and toxicological test results often drive the selection of lead drug candidates (IND) applications are in this revision in the centre. With the goal of drug development being FDA approval of a New Drug Application (NDA) and intended for use in the clinical, many project development teams find it useful to develop a target product profile (TPP)\ to target non-clinical concerns. Development Analytical methods may need to be developed for different materials and conditions. Quality control in that is responsible for monitoring GMP analytical work, good clinical practices given in ICH guidelines.

Keywords: Clinical Trials, Preclinical Studies, Clinical studies, NDA.