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The AAPS Journal · 2026 · Vol. 28 · Issue 3 · Springer
Tissue biodistribution characterization represents a critical component of monoclonal antibody (mAb) development, yet industry practices remain fragmented despite regulatory emphasis on comprehensive exposure assessment. The IQ Consortium Tissue Concentration Working Group surveyed eleven pharmaceutical companies to evaluate current methodologies in mAb tissue concentration analysis and establish consensus recommendations. Org...
The AAPS Journal · 2026 · Vol. 28 · Issue 2 · Springer
Accurate assessment of tissue distribution for oligonucleotide therapeutic (ONT) drug candidates is essential for understanding pharmacokinetic behavior and predicting therapeutic efficacy. ONTs present a unique challenge with their rapid systemic clearance coupled with prolonged tissue retention, making comprehensive tissue concentration evaluation critical for successful drug development. The IQ Consortium Tissue Concentrati...