TO: Members, Advisory Committee
for Pharmaceutical Science
FROM: Helen Winkle
Acting Director, Office of Pharmaceutical Science, CDER, FDA
Date:
Re:
Errata to Memo dated
In the section
"Bioavailability / Bioequivalence of Endogenous Drugs", the last
sentence should read as follows
"Abbott
Laboratories will present an overview of research it conducted on baseline
correction methods for leveothyroxine sodium. Some of Abbott's research finding were recently adopted by FDA for bioequivalence
testing on levothyroxine products. Abbott will also discuss other
approaches for baseline correction."