Laboratory Manual (OBX319-301)

Document ID: TMF-011
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH E6(R3)

Laboratory Manual — OBX319-301

Central/local laboratory procedures for OBX319-301: sample collection, handling, and shipment for the safety and SLEDAI-2K-supporting analyses (including PK and anti-drug antibody samples), with reference ranges and flagging. ICH E6(R3).