Methodologies for the transfer of analytical methods: a review.
The transfer of a method from a laboratory to a production site is an important step in the development cycle of new pharmaceutical products. Method transfers are increasingly implemented due to the economical pressure coming from the rationalization of production sites, analytical subcontracting and fusion of pharmaceutical groups. However, no official guidance regarding study design, data analysis, or decision procedures is present neither in FDA documents nor in ICH documents for method transfers. The experiments performed in such a transfer and the methodology used to accept or reject it should be fitted for purpose. In order to provide to analysts a global view of the problematic of analytical method transfer, this paper reviews the documentation available in the scientific literature about the design of transfer studies and the required sample size. Special focus is also made on the statistical methodologies available for decision making with particular emphasis on risk management. Examples of transfer of pharmaceutical, bio-pharmaceutical and biological methods published in the literature are reviewed in order to illustrate the various possibilities among the strategies for methods transfer.
Rozet
E
E
Laboratory of Analytical Chemistry, CIRM, Department of Pharmacy, University of Liège, B-4000 Liège, Belgium.
Dewé
W
W
Ziemons
E
E
Bouklouze
A
A
Boulanger
B
B
Hubert
Ph
P
D056246:Chemistry, Analytic / Q000331:legislation & jurisprudence / Q000592:standards; D017408:Guidelines as Topic; D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards; D018581:Technology Transfer; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States