New White Paper
Phase I Strategies Tailored for Success
Learn about advanced Phase I trial designs that help accelerate your pathway to approval.
With the FDA’s launch of Project Optimus, which emphasizes the need to determine the optimal safe and efficacious doses earlier, designing the right Phase I study protocol for your therapy has become more important for success.
Download this white paper to learn more about:
- Strategies for more accurate dose escalation to find the maximum effective dose
- Benefits and Limitations of Rule-base, Model-based, and Model-assisted study designs
- Accelerating your pathway to approval by gathering more information earlier
Download White Paper
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Have questions about how TD2 can assist with your regulatory needs? Reach out to our expert staff today to get started.