Staff Fellow US Food and Drug Administration Silver Spring, Maryland
Asymmetrical flow field-flow fractionation (AF4) is an emerging analytical technology that has been increasingly utilized by the pharmaceutical industry to characterize their products, and the data are routinely included in the Sponsor’s package to support the regulatory application. However, there is insufficient information available in either literature or guidance documents on the key elements of the AF4 technique, such as method development strategy, acceptance criteria and reporting category. Compared to conventional liquid chromatography techniques where harmonized regulatory standards are well established, AF4, as a relatively new technique, has a lack of standardization procedures. This presentation will discuss several considerations in method development such as optimization of separation efficiency, and establishment of acceptance criteria for AF4 when characterizing complex pharmaceutical products.
Learning Objectives:
Upon completion, participants will be able to know what information can be obtained with an AF4 technique for complex drug product.
Upon completion participants will be able to understand the current challenges associated with method development of AF4.
Upon completion participants will be able to know what analytical elements should be considered when developing an AF4 method.
Upon completion participants will be able to know the potential source of bias that may be generated by an AF4 characterization
