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ADME: Assessing Pharmacokinetic-Pharmacodynamic Parameters of Oligonucleotides
Rasmus Jansson-Löfmark1, Christine Ahlström2, Peter Gennemark2
1DMPK, Research and Early Development Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. Rasmus.Jansson.Lofmark@astrazeneca.com.
Abstract:
We describe tactics to assess pharmacokinetic (PK) and pharmacodynamic (PD) parameters of oligonucleotides. The chapter includes recommendations on the design of single-dose preclinical PK studies, preclinical PKPD studies, and toxicological studies, and on best practice for scaling PK and PD parameters from animal to human. We focus on single-stranded oligonucleotides, but relevant differences to double-stranded RNAs are also addressed.
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