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[Hitnews] The importance of TPP (Target Product Profile) in successful new drug development

“The starting point for successful new drug development lies in the TPP (Target Product Profile). Proper planning from the outset is crucial for new drug development.”

 

Jinhak Kim, Senior Director at C&R Research, stated this during his lecture on ‘Development of new drug modality’ at the ‘2024 The 9th C&R Research Symposium’ held on the 28th of last month.

 

The TPP is a summary format outlining how a drug will be developed, from the discovery of candidate substances through preclinical and clinical stages to launch and marketing. As the pharmaceutical market has significantly advanced and grown, the importance of TPP has increased accordingly.

 

He emphasized, “During the candidate substance discovery stage, the TPP should consider market potential, safety, efficacy, compliance differences compared to competing products, expected pricing, insurance coverage possibilities, patent issues, and clinical superiority.”

 

He further noted, “If the TPP is revised after the completion of Phase 1 clinical trials, it allows for an assessment of the market value when technology transfer (L/O) occurs,” indicating that the TPP serves as a guide for the direction of drug development.

 

Please check out further details by following the link below.

 

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