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Antibody Drug Conjugate Analysis: How Partnering with a Bioanalytical CRO Can Ease Preclinical ADC Programs

The potential of antibody drug conjugates (ADCs) to provide targeted therapies for cancers and other devastating diseases have made them popular candidates for drug development programs. However, as we discussed recently in Drug Discovery and Development, the failure of several ADCs during phase II and III trials due to limited efficacy proves more complete bioanalysis … read the full article » »

Other Categories: Biomarkers, LC-MS/MS Methods, Ligand Binding Assays (LBA)



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What Level of Bioanalytical Method Validation is Right for My Early Stage Drug Development Study?

During late phase drug discovery, everyone follows well established FDA bioanalytical method validation guidelines. However, opinions vary widely about what validation is necessary for early- to mid-phase studies. We are often asked by our clients: “How robust do I need this assay to be?” “At what point can I use this data to present to … read the full article » »

Other Categories: LC-MS/MS Methods, Ligand Binding Assays (LBA)



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