FDA guidelines for bioanalytical methods

FDA guidelines for bioanalytical methods ensure accurate, reliable, and consistent measurement of drugs and their effects in biological samples like blood or urine. They specify how to develop, validate, and maintain these analytical techniques to produce valid data for clinical studies. The guidelines cover aspects such as method accuracy, precision, sensitivity, and stability, aiming to protect patient safety and support drug approval processes. Essentially, they set standards so that tests are trustworthy and reproducible across laboratories, ensuring that decisions about a drug's safety and effectiveness are based on solid scientific evidence.