Drug metabolism and pharmacokinetic strategies for oligonucleotide- and mRNA-based drug development

Drug Discovery Today
Shalini AnderssonLars Weidolf

Abstract

Oligonucleotide and modified mRNA therapeutics have great potential to treat diseases that are currently challenging to cure and are expanding into global and chronic disease areas such as cancer and various cardiovascular diseases. Advanced drug delivery systems or ligand-drug conjugates are utilized to achieve 'the right dose to the right target' to benefit efficacy and safety in patients. Chemistry and ADME characteristics distinguish these therapeutics from small molecules. Understanding the scalability and translatability between species and compound properties is crucial for robust nonclinical PKPD predictions to support clinical study design. Although the field has been developing for three decades, there is still room for innovation but also a need for nonclinical regulatory guidance to address these new modalities.

Citations

May 12, 2020·The International Journal of Biological Markers·Shuli TangXiaoyi Huang
Aug 11, 2019·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Brooke M Rock, Robert S Foti
Apr 26, 2019·Analytical and Bioanalytical Chemistry·Martin EnmarkTorgny Fornstedt
Dec 10, 2019·Analytical and Bioanalytical Chemistry·Martin EnmarkTorgny Fornstedt
Oct 28, 2019·Bioanalysis·Neil Henderson, Amanda Wilson
May 16, 2019·Nucleic Acid Therapeutics·Elise Malek-AdamianMasad J Damha
Mar 2, 2021·Biochemical Pharmacology·Christopher L BarkauKeith T Gagnon
Apr 17, 2021·Drug Discovery Today·Lars WeidolfShalini Andersson
Jan 19, 2021·ACS Biomaterials Science & Engineering·Stephanie L McNamaraDavid J Mooney

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