Document Detail


Considerations for Assessment of Reproductive and Developmental Toxicity of Oligonucleotide-Based Therapeutics.
MedLine Citation:
PMID:  25137397     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
This white paper summarizes the current consensus of the Reproductive Subcommittee of the Oligonucleotide Safety Working Group on strategies to assess potential reproductive and/or developmental toxicities of therapeutic oligonucleotides (ONs). The unique product characteristics of ONs require considerations when planning developmental and reproductive toxicology studies, including (a) chemical characteristics, (b) assessment of intended and unintended mechanism of action, and (c) the optimal exposure, including dosing regimen. Because experience across the various classes of ONs as defined by their chemical backbone is relatively limited, best practices cannot be defined. Rather, points to consider are provided to help in the design of science-based reproductive safety evaluation programs based upon product attributes.
Authors:
Joy Cavagnaro; Cindy Berman; Doug Kornbrust; Tacey White; Sarah Campion; Scott Henry
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-8-19
Journal Detail:
Title:  Nucleic acid therapeutics     Volume:  -     ISSN:  2159-3345     ISO Abbreviation:  Nucleic Acid Ther     Publication Date:  2014 Aug 
Date Detail:
Created Date:  2014-8-19     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101562758     Medline TA:  Nucleic Acid Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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