title: Capsule review on bioanalytical method transfer: opportunities and challenges for chromatographic methods.
abstract: With the globalization of drug development activities, transferring a validated bioanalytical procedure to a different site within a pharmaceutical company, or to one or multiple contract research organizations has been dramatically increased in recent years. Undeniably, bioanalytical method transfer is the needed step prior to routine sample analysis at the receiving laboratory. It is clearly stated in the 2001 US FDA Guidance on Bioanalytical Method Validation that a partial validation is needed for method transfer between laboratories. In the current EMA draft guidelines on method validation, the necessity of a method transfer is also emphasized. However, the above guidelines do not give many details on how and when a method transfer validation should be conducted. There is a need for a step-by-step deliberation on the overall strategies, procedures and even technical details for a successful bioanalytical method transfer. In this article, we review the contemporary information available in the scientific literature on method transfer and illustrate various bioanalytical method transfer scenarios using case studies. A 'flexible and fit-for-purpose' bioanalytical method transfer strategy is proposed.
authors.affiliation: Frontage Laboratories, Inc., 105 Great Valley Parkway, Malvern, PA 19355, USA. Johnlin@frontagelab.com
authors.forename: Zhongping John
authors.initials: ZJ
authors.lastname: Lin
authors.forename: Wenkui
authors.initials: W
authors.lastname: Li
authors.forename: Naidong
authors.initials: N
authors.lastname: Weng
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods / Q000592:standards*; D005069:Evaluation Studies as Topic; D017408:Guidelines as Topic; D007753:Laboratories; D013058:Mass Spectrometry / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000592:standards; D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards; D018581:Technology Transfer; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations