Guidance for Industry: Stability Testing: Photostability Testing of New211 Veterinary Drug Substances and Medicinal Products, VICH GL5. Final Guidance

摘要

This guidance is an annex to the VICH parent guidance entitled 'Stability Testing211u001eof New Veterinary Drug Substances and Medicinal Products' (VICH GL3). It 211u001eprimarily addresses the generation of photostability information for submission 211u001ein new animal drug applications (referred to as Registration Applications in the 211u001eVICH parent guidance) for new molecular entities and associated drug products.