Amongst others, the USP published the received comments and responses to General Chapter/Section: <1032> Design and Development of Biological Assays in the Commentary – First Supplement to USP 35-NF 30.
The USP received 13 comments to different parts of this chapter. Comments to the following topics are included:
The complete comments can be found at Commentary – First Supplement to USP 35-NF 30.
In this respect you may also want to pay attention to ECA's New Education Course on "Bioassays, and Bioanalytics" from 27-28 March 2012 in Copenhagen, Denmark.
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)