PT  - JOURNAL ARTICLE
AU  - Dennis Jenke
TI  - Moving Forward towards Standardized Analytical Methods for Extractables and Leachables Profiling Studies
AID  - 10.5731/pdajpst.2015.01089
DP  - 2015 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 471--476
VI  - 69
IP  - 4
4099  - http://journal.pda.org/content/69/4/471.short
4100  - http://journal.pda.org/content/69/4/471.full
SO  - PDA J Pharm Sci Technol2015 Jul 01; 69
AB  - This commentary considers the standardization of analytical methods used in extractables and leachables screening and proposes that method standardization is not the end goal but rather the necessary first step for enabling efficient, effective, robust, and consistent extractables and leachables profiling. Standardized methods are the platform upon which a knowledge set and a knowledge management process can be built, and it is the combination of the methods, the set, and the process that facilitates extractables and leachables profiling.