Bioanalytical method development process
Excellent specificity, consistency, and robustness are key characteristics of ADMET assays in the drug development process.
Therefore, Polyphor follows the following standards and rules for optimal and reliable ADMET assay method development:
- State-of-the-art equipment and techniques
- Minimizing inter-assay and inter-laboratory variability
- Straightforward and standardized performance and evaluation
- Regulatory authority guideline demands
- Stringent quality control settings, preferably according to Good Laboratory Practice (GLP) guidelines
- Robust and consistent data processing, storage, and archiving
Polyphor’s method development progresses through three phases:
- Implementation and routine use
All workflows in this process are well documented and archived. They are completely aligned with the above listed standards and we fully operate according to GLP guidelines on a voluntary basis.
Assay raw data are processed, stored and archived using high end IT-tools. Based on these tools fast retrieval and comparative assessment of results from different compounds can easily be performed.