Module232025

Takeda R & D Examples

Pre-clinical

Clinical

Launch

I

II

III

Film-coated tablet (FCT) , immediate-release 15 mg, 30mg

TAK-279, psoriasis & others

immediate-release, chewable tablet, 5 mg, 15 mg, and 25 mg

pediatric formulation, 2- 17y

FCT, immediate release Mini-tablet

TAK-861, narcolepsy

pediatric formulation, 2 – 17y

immediate-release Mini-tablet

-> Pediatric compliance of dosage form was considered from the start in R & D; dose-finding study adults during pII reflected PBPK/PD modeling

TAK-227, celiac disease

pediatric formulation

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Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs