Navigating the complex pathways of clinical studies guided by regulatory dossier requirements can be daunting. Achieving the right balance is critical; underpreparing can lead to delays, and overpreparing can inflate costs. Therefore, collaborating with seasoned partners who can offer informed decision-making is essential to ensure that necessary tasks are completed efficiently and on time.
In this webinar, we will provide guidance through common pitfalls and key factors during preclinical, early, and late clinical development phases of OINDP (Orally Inhaled and Nasal Drug Products ) product development to help keep your program both accelerated and risk-averse. Our review will cover the specifics of required tests, the levels of target validation needed, and the differing expectations of various regulatory agencies. Understanding these differences is vital to ensuring your study meets the necessary standards and progresses smoothly.
Additionally, we will explore strategies for mitigating risks in Chemistry, Manufacturing, and Controls (CMC) studies. Addressing these risks early in the development process is a proactive approach that optimizes performance and avoids redundant tasks as you move towards final formulation. This strategy helps to ensure that your development process remains efficient and forward-looking.
The field of orally inhaled and nasal drug products is advancing rapidly. Collaborating with experts who understand the complexities of the device, the drug, the formulation, and analytical activities in combination product development is crucial. Such a comprehensive perspective is necessary to meet regulatory requirements and streamline clinical development from start to finish. By leveraging expert knowledge, you can navigate the intricate details of the development process, ensuring that all aspects of your project are aligned with regulatory expectations and industry best practices.
In summary, successful navigation of clinical studies for OINDPs requires a balanced approach to preparation, early risk mitigation in CMC studies, and collaboration with knowledgeable partners. This holistic strategy will help optimize your development process, satisfy regulatory demands, and ensure timely progress towards your final formulation.
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