Linked Life Data

8155981

Source:http://linkedlifedata.com/resource/pubmed/id/8155981

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
1994-5-16
pubmed:abstractText
This article focuses on pharmacology and toxicology data that should be included in an Investigational New Drug Application (IND), a request to use an investigational drug in clinical trials. In general, pharmacology and toxicology testing programs for antisense compounds are held to the same regulatory standards applied to other new therapeutic classes. Biological properties of oligonucleotide therapeutics are mentioned where they may pertain to clinical safety issues. Nonclinical data submitted to the IND should characterize the pharmacology, disposition, and toxicology of a new drug; these data form the basis for clinical risk assessment. Concomitant evaluation of pharmacokinetics allows for better interpretation of in vivo studies and increased accuracy of dose extrapolation to humans. Recommendations for nonclinical drug development will be modified as new information regarding the biological properties of oligonucleotides becomes available.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
1050-5261
pubmed:author
pubmed:issnType
Print
pubmed:volume
3
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
399-404
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
1993
pubmed:articleTitle
Regulatory considerations for evaluating the pharmacology and toxicology of antisense drugs.
pubmed:affiliation
Food and Drug Administration, Committee on Antisense Pharmacology and Toxicology, Rockville, Maryland 20852.
pubmed:publicationType
Journal Article