P2, N=17, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial primary completion date: Nov 2025 --> Nov 2026 | Trial completion date: Nov 2025 --> Nov 2026
28 days ago
Trial completion date • Trial primary completion date
After performing a validation exercise, the method proved to be accurate, specific, and linear within an affinity interval of 75 to 130%; precise with a confidence interval of 93.6 to 114.2% and a coefficient of variation of 12.6%. The validation exercise proved that the proposed cell-based method is a viable alternative to evaluate the biological activity of filgrastim via the affinity for its receptor and it is suitable to be included as part of its biological characterization exercises as well as in comparability exercises for products coming from distinct manufacturing processes.
Larger studies are warranted to evaluate its long-term safety and efficacy. This trial is registered at https://irct.behdasht.gov.ir/ in Iranian Registry of Clinical Trials (IRCT) # IRCT20150125020786N3.