USP Upgrading Bioassay Coverage; FDA Weighs In on Bioassays at AAPS’ National Biotech Meeting

The US Pharmacopeia (USP) is upgrading its coverage related to bioassays to keep pace with the evolving science and technology.  In its July/August Pharmacopeial Forum, USP is proposing revisions for public comment to General Chapters <1032>, <1033>, and <1034>, which address the design, validation, and analysis of bioassays respectively.

In its announcement of the proposed changes, USP explained that three ad hoc advisory panels have created “a comprehensive suite of bioassay guidance chapters that have emanated from USP’s core compendia bioassay standards.”

In March 2008, USP had proposed a comprehensive revision to its General Chapter <111>, which covers the analysis of biological assays.  The proposed revision elicited three primary concerns:  1) the evaluation of curve similarity, 2) the utility of equivalence testing as an effective statistical method in several areas of bioassay data analysis, and 3) the best means for combining data from multiple assays.

Based on the comments received, USP shifted its focus to creating a new General Chapter <1034> to focus specifically on the analysis of biological assays and address the concerns raised about Chapter <111>.  A new General Chapter <1032> to address the design of biological assays is also being proposed.

The revision to USP’s existing Chapter <1033> on the validation of biological assays reflects the comments received on an original proposal to revise the chapter released in March 2009.

Subscribers can read more about the proposed chapter revisions and download the new proposed chapters here.  Also provided are comments from an FDA regulator on key bioassay concerns.