Role of formulation science in different stage of drug development process
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Formulation science plays a key role throughout the various stages of drug development. It begins with supporting preclinical tests by developing formulations for screening and testing candidate compounds. As clinical trials are prepared, formulation scientists work to develop stable, scalable formulations and manufacturing processes to produce materials for Phase 1, 2 and 3 trials. Later in development, formulation science can help expand a drug's approved uses or switch it from prescription to over-the-counter status through reformulation efforts.
Role of formulation science in different stage of drug development process
- 1. Development stage Drug discovery Clinical development Lifecycle management Preformulation Formulation support for preclinical tests Evaluating the develop ability of clinical candidates Formulation and process development On time support of clinical trial material Reformulation Indication expansion RX to OTC switch Role of formulation science in different stage of drug development process Assay/ Development screening Hit-to-lead/ Lead optimization commercializationpreclinical Phase I Phase II Phase III s.gurubalaji@gmail.com Ø Ø Ø Ø Ø Ø Ø