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Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity.

Publication ,  Journal Article
Wang, J; Lon, H-K; Lee, S-L; Burckart, GJ; Pisetsky, DS
Published in: Ther Innov Regul Sci
November 2015

The field of oligonucleotide (OGN)-based therapeutics has been growing dramatically in the past decade, providing innovative platforms to develop agents for the treatment of a wide variety of clinical conditions. OGN agents have unique physicochemical properties and pharmacokinetic/pharmacodynamic characteristics. This review considers findings from the literature and information on new molecular entities submitted to the US Food and Drug Administration as OGN-based therapeutics. In addition, the article discusses several challenging issues from the perspective of clinical pharmacology, emphasizing the potential of immunogenicity, the effect of renal impairment on OGN exposure, drug-drug interactions, and the utility of pharmacokinetic/pharmacodynamic modeling. The field of OGN-based therapeutics is in evolution and will benefit from further studies as well as clinical experience to formulate guidelines and promote the development of this class of agents.

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Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

November 2015

Volume

49

Issue

6

Start / End Page

861 / 868

Location

Switzerland

Related Subject Headings

  • Statistics & Probability
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics
 

Citation

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Wang, J., Lon, H.-K., Lee, S.-L., Burckart, G. J., & Pisetsky, D. S. (2015). Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity. Ther Innov Regul Sci, 49(6), 861–868. https://doi.org/10.1177/2168479015592195
Wang, Jian, Hoi-Kei Lon, Shwu-Luan Lee, Gilbert J. Burckart, and David S. Pisetsky. “Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity.Ther Innov Regul Sci 49, no. 6 (November 2015): 861–68. https://doi.org/10.1177/2168479015592195.
Wang J, Lon H-K, Lee S-L, Burckart GJ, Pisetsky DS. Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity. Ther Innov Regul Sci. 2015 Nov;49(6):861–8.
Wang, Jian, et al. “Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity.Ther Innov Regul Sci, vol. 49, no. 6, Nov. 2015, pp. 861–68. Pubmed, doi:10.1177/2168479015592195.
Wang J, Lon H-K, Lee S-L, Burckart GJ, Pisetsky DS. Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity. Ther Innov Regul Sci. 2015 Nov;49(6):861–868.
Journal cover image

Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

November 2015

Volume

49

Issue

6

Start / End Page

861 / 868

Location

Switzerland

Related Subject Headings

  • Statistics & Probability
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics