Key Analytical Attributes for IND Filing: Ensuring Your Biologic Is Ready for First-in-Human Trials Introduction Some believe that the Chemistry, Manufacturing, and Controls (CMC) section of an IND is Read More November 7, 2025
Drug Product In-Use Studies: An Overlooked Critical Supporting Stability Study Introduction Drug product in-use studies represent critical yet underestimated components of drug product quality, particularly Read More October 5, 2025