What is the purpose of regulatory inspection for GCP compliance?

The Disease Activity Score is not suitab

The Disease Activity Score is not suitable as the sole criterion for initiation and evaluation of anti–tumor necrosis factor therapy in the clinic: Discordance between assessment measures and limitations in questionnaire use for regulatory purposes

✍ Frederick Wolfe; Kaleb Michaud; Theodore Pincus; Daniel Furst; Edward Keystone 📂 Article 📅 2005 🏛 John Wiley and Sons 🌐 English ⚖ 218 KB 👁 2 views

## Abstract ## Objective The Disease Activity Score (DAS) is widely used in clinical trials. A DAS of 5.1 defines the level of severe rheumatoid arthritis (RA) and is the criterion for the initiation of anti–tumor necrosis factor therapy in the UK and The Netherlands. In North America, similar rul