Linked Life Data

2131019

Source:http://linkedlifedata.com/resource/pubmed/id/2131019

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
1991-12-17
pubmed:abstractText
Monoclonal antibody-based therapeutic products are subject to the same regulatory review procedures and submissions requirements as more traditional pharmaceutical agents. In addition, the FDA often asks for specific information on the unique aspects of the manufacture, characterization, and testing of these products. Agency concern begins with the origin of the hybridoma cell line and continues through preclinical safety testing and clinical trials. Specific regulatory issues are often decided on a case-by-case basis with the FDA reviewers. Implementing an effective strategy for identifying and addressing these issues and concerns is a critical part of the development process.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
1046-1906
pubmed:author
pubmed:issnType
Print
pubmed:volume
3
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
75-98
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
1990
pubmed:articleTitle
Regulatory agency concerns in the manufacturing and testing of monoclonal antibodies for therapeutic use.
pubmed:affiliation
Bio Response, Inc., Hayward, California.
pubmed:publicationType
Journal Article, Review