Answer:
Method validation studies
Explanation:
Method Validation:
- Method validation is a process that evaluates an analytical method for its suitability to the intended purpose of the scientific study. This is an effective tool to assess the quality and reliability the results of a particular study.
- According to the FDA, method validation procedures must assess the results and conclusions of a scientific study for accuracy, sensitivity, specificity, and reproducibility.
- The USP also requires analytical method validation on the following measures:
- Accuracy
- Precision
- Specificity
- Limit of detection
- Limit of quantitation
- Linearity and range
- Ruggedness
- Robustness
The answer to this question is, "...signing a consent form."
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