{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["8(3)"],"submitter":["Xin L"],"funding":["WuXi Biologics USA"],"pubmed_abstract":["<h4>Background</h4>In drug development, placebo-controlled trials are vital for assessing treatment efficacy. Developing a suitable placebo for injectable biologics presents unique challenges, particularly in matching the physical characteristics of the active drug without containing its active pharmaceutical ingredient.<h4>Methods</h4>Our study developed a methodology for biologic placebo formulations, focusing on color and viscosity matching, in relevant chemical matrixes. A custom color deconvolution algorithm was used for precise color-matching, and sodium carboxymethyl cellulose (Na-CMC) was employed to adjust viscosity in different buffer systems. The interactions between buffers, color agents, and excipients were investigated to ensure consistency in physical properties. Stability t"],"journal":["Antibody therapeutics"],"pagination":["177-188"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12202036"],"repository":["biostudies-literature"],"pubmed_title":["Matching placebo development for injectable biologics-a practical tutorial."],"pmcid":["PMC12202036"],"pubmed_authors":["Xin L","Hashemi V","Li X","Li Y","Zhang Z","Chen W","Qin G","Ren S","Shah K"],"additional_accession":[]},"is_claimable":false,"name":"Matching placebo development for injectable biologics-a practical tutorial.","description":"<h4>Background</h4>In drug development, placebo-controlled trials are vital for assessing treatment efficacy. Developing a suitable placebo for injectable biologics presents unique challenges, particularly in matching the physical characteristics of the active drug without containing its active pharmaceutical ingredient.<h4>Methods</h4>Our study developed a methodology for biologic placebo formulations, focusing on color and viscosity matching, in relevant chemical matrixes. A custom color deconvolution algorithm was used for precise color-matching, and sodium carboxymethyl cellulose (Na-CMC) was employed to adjust viscosity in different buffer systems. The interactions between buffers, color agents, and excipients were investigated to ensure consistency in physical properties. Stability t","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Jul","modification":"2026-06-03T12:12:36.878Z","creation":"2026-04-27T03:11:41.997Z"},"accession":"S-EPMC12202036","cross_references":{"pubmed":["40583907"],"doi":["10.1093/abt/tbaf009"]}}