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Springer Nature2
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The AAPS Journal2
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20221
20141
Claudio Calonder results 2 · Newest (Page 1/1, per page 25)
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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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Automation Practices in Large Molecule Bioanalysis: Recommendations from Group L5 of the Global Bioanalytical ConsortiumNARA Subscribed
The AAPS Journal · 2014 · Vol. 16 · Issue 1 · Springer
Ago Ahene; Claudio Calonder; Scott Davis; Joseph Kowalchick; Takahiro Nakamura; Parya Nouri; Igor Vostiar; Yang Wang; Jin Wang
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