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Springer Nature2
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The AAPS Journal2
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20261
20221
Lydia Michaut results 2 · Newest (Page 1/1, per page 25)
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Industry Practices in Oligonucleotide Tissue Biodistribution Assessment: An IQ consortium Cross-Industry Survey of Current Approaches and Emerging TrendsNARA Subscribed
The AAPS Journal · 2026 · Vol. 28 · Issue 2 · Springer
Michael McCoy; Huaping Tang; Lydia Michaut; Irina Laczkovich; Girish Chopda; Linzhi Chen; Isha Taneja; C. Andrew Boswell; Guangnong Zhang
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...
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When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity PlatformNARA Subscribed
The AAPS Journal · 2022 · Vol. 24 · Issue 3 · Springer
Gregor P. Lotz; Karin Benstein; Karien Bloem; Harm Buddiger; Claudio Calonder; Stefanie Elm; Elena Fernandez; Joanne Goodman; Boris Gorovits; Joanna Grudzinska-Goebel; Melody Janssen; Vibha Jawa; Daniel Kramer; Linlin Luo; Mantas Malisauskas; Lydia Michaut; Martin Schäfer; Sebastian Spindeldreher; Martin Ullmann; Karin Nana Weldingh; Arno Kromminga; Veerle Snoeck
The determination of a tailored anti-drug antibody (ADA) testing strategy is based on the immunogenicity risk assessment to allow a correlation of ADAs with changes to pharmacokinetics, efficacy, and safety. The clinical impact of ADA formation refines the immunogenicity risk assessment and defines appropriate risk mitigation strategies. Health agencies request for high-risk biotherapeutics to extend ADA monitoring for patient...
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