Regulatory evaluation of antiviral drug resistance in the era of next-generation sequencing

Biomark Med. 2015;9(11):1047-51. doi: 10.2217/bmm.15.63. Epub 2015 Oct 28.

Authors

Eric F Donaldson¹, Damon J Deming¹, Julian J O'Rear¹, Lisa K Naeger¹

Affiliation

¹ FDA/OMPT/CDER/OND/OAP/Division of Antiviral Products, Food & Drug Administration, Division of Antiviral Products, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

PMID: 26508693
DOI: 10.2217/bmm.15.63

No abstract available

Keywords: antiviral drug resistance; next-generation sequencing; resistance-associated substitutions; treatment-emergent substitutions.

MeSH terms

Artifacts
Drug Approval / legislation & jurisprudence*
Drug Resistance, Viral*
High-Throughput Nucleotide Sequencing*
Social Control, Formal*
United States
United States Food and Drug Administration