WHITE PAPER: Bring Quality OINDPs to Market Faster Than Ever Before | Proveris Scientific
The Proveris by Design™ process offers a formalized approach to product development, all the while automating in vitro testing, and streamlining troubleshooting. It is an indispensable tool for successfully developing nasal spray and inhalation drug products as well as critical to creating effective manufacturing processes for released products.
When employed early on during the R&D phase, this approach saves time and money for product development and streamlines preparation of regulatory submission packages. It often results in shorter approval timelines and minimized queries from regulatory agencies.
Click here to download the whitepaper.
CONTENTS
- Quality by Design, an approach endorsed by the US FDA
- Best practices for evaluating formulation, device, and human-usage factors
- Generic product development: how to benchmark a reference product to achieve performance targets
- Innovator product development: in vitro testing approaches to demonstrate in vivo correlation
- Solutions and tools for achieving repeatable, reproducible, and robust methods
- In-depth look at spray pattern and plume geometry as sensitive analytical techniques
- Novel characterization techniques for demonstrating correlation to clinical performance
- How Proveris can help
Total Page Views: 3181
