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Pharmaceutical Regulatory science bpharmacy final year bp804 ET

Unit I 

New Drug Discovery and development

Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical

activities, clinical studies, Innovator and generics, Concept of generics, Generic drug

product develop



Drug discovery is a process aimed at identifying a compound therapeutically useful in

remedial and treating diseases. The process of drug discovery involves the identification of

candidates, synthesis, characterization, screening, and assays for therapeutic efficacy.

Researchers constantly put their efforts to discover new drugs through new insights into a

disease process that allow them to design a product to overcome the effects of the disease.

Several tests are conducted ona compound to find possible useful effects against number

of diseases. In addition, existing treatments that have unanticipated effects can also be

explored. Very sophisticated approaches are often envisaged such as; inhibiting complex

enzyme pathways, preventing invading microorganisms or invasive cancer cells from

multiplying, replacing natural hormones that are lacking in the body or a host are other

possible ways to treat medical conditions. New technologies that provide new ways to target

medical products to specific sites within the body or to manipulate genetic material could

also be attempted. Next to this stage in the process, thousands of candidate drugs are made

available for development as a medical treatment. Unfortunately, after early testing, only a

  • few numbers of compounds look promising and call for the further studies.