Journal
AAPS JOURNAL
Volume 16, Issue 2, Pages 352-356Publisher
SPRINGER
DOI: 10.1208/s12248-014-9566-y
Keywords
bioanalytical method validation; internal standards; metabolites; reference standards; stock solutions
Categories
Ask authors/readers for more resources
The continued globalization of pharmaceutics has increased the demand for companies to know and understand the regulations that exist across the globe. One hurdle facing pharmaceutical and biotechnology companies developing new drug candidates is interpreting the current regulatory guidance documents and industry publications associated with bioanalytical method validation (BMV) from each of the different agencies throughout the world. The objective of this commentary is to provide our opinions on the best practices for reference standards and key reagents, such as metabolites and internal standards used in the support of regulated bioanalysis based on a review of current regulatory guidance documents and industry white papers for BMV.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available