Recommendations and best practices for reference standards and reagents used in bioanalytical method validation.
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.
Covance Laboratories Inc., 3635 Concorde Parkway, Suite 100, Chantilly, Virginia, 20151, USA, joseph.bower@covance.com.
Joseph F
JF
Bower
Jennifer B
JB
McClung
Carl
C
Watson
Takahiko
T
Osumi
Kátia
K
Pastre
D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards; D012015:Reference Standards; D012996:Solutions
D012996:Solutions