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Performing full validation during early phases of drug development may give you more information, but with early formulation development and frequent process changes, full validation of a method too soon can lead to unnecessary delays and cost increases. It is almost certain that changes will occur during product development, some of which include:
- API development process
- Formulation development
- Dosing levels
- API and product specifications
- Packaging
Developing a sound, phase-appropriate approach to method validation provides scientifically supportable data to help progress development to the next phase in a more timely and cost-efficient manner while still meeting regulatory requirements.
The smart choice for phase-appropriate method development and validation
At ABC Laboratories, our scientific experts have the analytical knowledge, tools and experience to help you determine the level of method development and validation needed at each phase and assist you with developing your product in a logical and justifiable manner. We will take the time to understand where you are in your program, where you want to be and what you need to get there. The combination of our scientific acumen and development experience will help guide you through each phase of your drug's development, so you can optimize value according to your development strategy and ensure short-term objectives are in line with long-term goals.
To learn more about how to optimize your program plan based on its phase of development, contact our expert, Dr. Wayland Rushing. |
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