What Challenges are Associated with Method Development?
Several challenges can arise during method development:
- Matrix Effects: Biological matrices such as plasma or urine can interfere with the detection of the analyte. - Stability: Some analytes may degrade over time or under certain conditions, complicating analysis. - Sensitivity Requirements: Achieving the required sensitivity, especially for low-abundance analytes, can be difficult. - Regulatory Compliance: Ensuring the method meets stringent regulatory guidelines can be challenging and time-consuming.