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The drug development process is typically divided into three major steps first Discovery phase pre clinical development clinical trial the boundary between preclinical development and clinical trial is sharply Defined by the feeling of an Investigational New Drug (IND). the adage begin with the end in mind is particularly appropriate for pre clinical development the resulting (IND) must support the plant clinical trial design the transition from Discovery to preclinical development is a Continuum and result of preliminary Pharmacology and toxicology testing often contribute to lead drug candidate selection the activities supporting on ( IND) applications are the subject of this overview the goal in drug development is FDA approval of a New Drug Application (NDA) and prescribed used in the clinic many project development team find it helpful to develop Target Product Profile (TPP) to guide pre clinical development. Analytical methods may need to be developed for a variety of materials and circumstances the quality control in it is responsible for the oversight of GMP analytical work, good clinical practices given by ICH guidelines.