Method development and validation of chemicals are not only essential but commonly used in drug development and manufacture and chemical analyses for other applications such as in ecotoxicology. Once a chemical analysis method has been developed, it is imperative to prove that the method is robust and suitable for its intended use. A validation process is performed to verify the method’s suitability and, if this is successful, the method is deemed valid to use for the intended purpose.
The development of methods and validation can be very complex and needs to be performed by highly educated, trained, and experienced chemists. The validation includes but is not limited to testing parameters such as specificity, limits of detection and quantification, linearity, accuracy, precision, and robustness.
Method development and validation are used in: