A proposed "fixed" range decision criteria for transfer of bioanalytical methods.
Many approaches have been proposed for decision criteria to judge whether or not transfer of bioanalytical methods has been successful. Many of these approaches involve mathematical and statistical complexities that limit their use routinely. The FDA accuracy criterion (+/-15%) without an allowance for imprecision may be used for method transfer and may result in a large numbers of method transfers being judged unacceptable when the method is valid under both conditions. An acceptance criterion should be based on the existing guidance, be convenient and be based on statistical principles that provide consistent and reasonable rejection rates. In the current paper, we propose a "fixed" range acceptance criteria based on the FDA bioanalytical guidance limits on precision and accuracy. While the proposed "fixed" range criteria shares the shortcomings of any other fixed criterion, there are advantages when compared to use of accuracy criterion alone. The proposed criterion is also more user-friendly. Data simulations were performed to assess the probabilities of successful transfer using the proposed criteria. With an experimental design consisting of 3 independent runs with 3 replicates per run, a fixed criterion of +/-20% of the reference method mean is proposed.
Shah
Kumar A
KA
Department of Pharmaceutics, Virginia Commonwealth University, Richmond, VA 23298, USA.
Karnes
H Thomas
HT
D005069:Evaluation Studies as Topic; D018581:Technology Transfer; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration