Pharmacy Manual (OBX319-301)

Document ID: TMF-010
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH E6(R3)

Pharmacy Manual — OBX319-301

Instructions for the site pharmacy in OBX319-301: receipt, storage (per the Module 3 conditions), accountability, preparation and subcutaneous administration of OBX-319, blinding handling, and return/destruction. ICH E6(R3); GMP Annex 13/IMP.