Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration
Li, Bing V., Davit, Barbara M., Lee, Christina H., Pabba, Santhosh K., Mahadevan, Chitra, Caramenico, Hoainhon T., Haidar, Sam H, Sanchez, Aida L., Sigler, Aaron W., Stier, Ethan M., Conner, Dale P.Volume:
15
Language:
english
Journal:
The AAPS Journal
DOI:
10.1208/s12248-012-9415-9
Date:
January, 2013
File:
PDF, 194 KB
english, 2013