The development, validation and transfer of analytical methods are key elements of a drug development plan. This white paper focuses on development and verification activities applicable to pharmaceuticals. The problem that is generally considered every day is that the benefits of a robust analysis method that can contribute to the overall development time and profitability of the program are underestimated. Legal activity is interconnected. They also recur, especially in the early stages of taking the drug. Parts of each process can occur at the same time or at different stages of drug development. References to another existing analytical method may be required for drug changes during drug development.
- Analytical Method Development compliance with ICH, USP, IP, BP
- API characterization and analysis
- Identification of Drug
- Optimization Of The Method
- Development Method Evaluation.
The development and validation of analytical methods are continuous and related activities that are carried out during the drug development process. Verify to verify that a method measures parameters as expected and sets performance limits of measurement. Clearly, the inconsistency is that the validated method will produce results within the range of known uncertainty. These results are very important for the continued development of medicine as they define the new knowledge base supporting the product.
The time and effort to develop developmentally rational, robust and transferable scientific analysis methods should be commensurate with the stage of drug development. The resources allocated for method validation should always be balanced with the regulatory requirements and market potential of the product.