Hardware Podcasts

165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New

Let's Combinate · 4 Dec 2024 · 1h 10m

What this episode covers

Marta New, CEO of Radyus Research, explains the anatomy of a Target Product Profile (TPP), a strategic document that aligns clinical, regulatory, and commercial goals early in drug development. She details the 10 critical sections of a TPP, including target indication, efficacy benchmarks, safety/toxicology thresholds, and go/no-go criteria, emphasizing that it serves as a roadmap from discovery to development. New highlights how integrating these elements early prevents costly failures and ensures that manufacturing, quality, and regulatory strategies are aligned with the final product's label.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Radyus Research
Also
FDA, EMA, 505(b)(2), IND, Phase 2

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