Navigating the intricate pathways of clinical studies based on regulatory dossier guidance can be overwhelming. Striking a balance is crucial: underpreparing may lead to setbacks, while over preparing unnecessarily inflates costs. It's essential to lean on seasoned partners for judicious decision-making, ensuring optimal activities are performed in a timely way.
We'll guide you through prevalent pitfalls and critical factors during preclinical, early, and late clinical development phases, ensuring your program remains both accelerated and risk-averse. We will also review the specifics of required tests, target validation levels, and how various regulatory agencies might have differing expectations for reviewing your study.
We will also review strategies to mitigate risks in CMC studies, considering them in the early phases of development. This proactive approach helps in optimizing performance without indulging in soon-to-be obsolete tasks as you edge closer to your final formulation.
The domain of orally inhaled and nasal drug products, though specialized, is on an upward trajectory. Collaborating with experts who grasp the intricacies of device, drug, formulation, and analytical activities within combination product development is pivotal. Only a comprehensive perspective can appease regulators and streamline clinical development from start to finish.#
Key Learning Objectives
- Understand FDA expectations
- Differentiate between CMC requirements for commercial products vs. clinical trials
- Learn what testing is needed to support clinical trials
- Learn what should be considered during development pre IND
