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Role of formulation science in different
stage of drug development process
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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Role of formulation science in different stage of drug development process

  • 1. Role of formulation science in different stage of drug development process
  • 2. 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