It also describes what is important when transferring a method.
The most comprehensive document is the conference report of the 1990 Washington conference: Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies, which was sponsored by, among others, the American Association of Pharmaceutical Scientists (AAPS), the AOAC and the U. The report has also been used as a basis for the FDA industry guidance document (8).
The scope of the method and its validation criteria should be defined early in the process.
These include the following questions: The method’s performance characteristics should be based on the intended use of the method.
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