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.

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
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