Sponsor conducting Xenograft studies on a tumor growth antagonist drug candidate needs to estimate the IC50 on a nonclinical study with multiple trial arms and treatment compounds.
Challenge: The study design is an involved lattice with multiple trial arms and with multiple CROs involved. Standard trial designs such as those in SEND are not sufficient. Tumor growth values are provided very frequently by multiple CROs. Sponsor-provided plasma concentration values are provided in Excel sheets. A method for estimating the inhibitory concentration...