ABF offers development of accurate and reliable analytical methods and validation according to ISO 17025 and FDA guidelines.
The Client benefits from our scientists’ experiences in sample preparation and analysis as well as from the state-of-the-art instrumentation available at ABF. Our philosophy is to develop methods that are accurate, precise, reliable, robust and suitable for application in larger sample series (hundred to thousands samples).
Method development and validation services include the following steps:
- Evaluation of published literature related to the method, if available
- Development of an accurate sample extraction, purification and enrichment (if necessary) procedure for the analyte(s) of interest
- Evaluation of adequate sample analysis techniques (e.g., LC-MS or GC-MS)
- Development of an accurate and robust analytical method for sample analysis
- Stability studies of the analyte in the biological matrix of interest (in particular, blood, plasma, serum, urine, saliva)
- Validation according to the FDA guidelines
- Generation of a standard operating procedure (SOP)
- Publication of the developed method, if agreed upon by the Client
Costs for method development and validation strongly depend on the complexity of the developed method for sample extraction and analysis.
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