New IVRT/IVPT eBook
This updated edition builds upon our previous publication by incorporating the latest industry guidelines from the US FDA and USP, along with our own practical experiences and direct communications with the FDA. It serves as a valuable resource designed to guide industry professionals through the complexities of IVRT and IVPT methodologies with contemporary insights and regulatory standards.
Unlike the previous eBook, which was based on existing industry practices and literature, this edition integrates the newly published guidelines from the US FDA and USP (General Chapter 1724). It provides readers with a comprehensive and current perspective on the development, validation, and application of these essential methodologies for topical drug products submitted in ANDAs.
The eBook offers an in-depth exploration of the scientific principles and practical challenges associated with IVRT and IVPT studies, enriched by new content drawn from direct communications and experiences with the FDA. It highlights standardized protocols developed to meet regulatory expectations, offering practical solutions to common obstacles, insights into study design and method validation, and essential information on interpreting results within the context of regulatory considerations for bioequivalence approaches.
Why Should you read this new edition?
If you’re engaged in the development and submission of topical drug products, this eBook is your indispensable guide to navigating the regulatory landscape efficiently and effectively. It not only demonstrates Diteba’s expertise in conducting IVRT and IVPT studies but also illustrates the evolution of these methodologies. By leveraging the insights and practical experiences shared, companies can streamline their development processes, ensure regulatory compliance, and bring their products to market promptly and cost-effectively.
Download the latest version of the eBook using the form at the bottom of the IVRT/IVPT page.
