Document Detail


Considerations in the development of live biotherapeutic products for clinical use.
MedLine Citation:
PMID:  18525102     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Food products in the United States (U.S.), including dietary supplements, may contain live microorganisms and can be promoted for general health, nutritional, or structure/function claims. In contrast, such preparations used with the intention of having a preventive or therapeutic effect in humans are regulated by the Food and Drug Administration (FDA) in the U.S. as biological products, specifically as live biotherapeutic products (LBPs). Discussion of considerations in the early development of LBPs may aid in preparation of an Investigational New Drug Application (IND) that is designed to collect clinical data to support marketing approval of a LBP in the U.S. for a specific clinical use. Product information is an important component of an IND to support a proposed clinical study.
Authors:
Jennifer J Ross; Philip E Boucher; Siba P Bhattacharyya; Dennis J Kopecko; Elizabeth M Sutkowski; Patricia J Rohan; Donna K F Chandler; Julienne Vaillancourt
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Current issues in molecular biology     Volume:  10     ISSN:  1467-3037     ISO Abbreviation:  Curr Issues Mol Biol     Publication Date:  2008  
Date Detail:
Created Date:  2008-06-05     Completed Date:  2008-09-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100931761     Medline TA:  Curr Issues Mol Biol     Country:  England    
Other Details:
Languages:  eng     Pagination:  13-6     Citation Subset:  IM    
Affiliation:
Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration/PHS, Rockville, MD, USA. jennifer.ross@fda.hhs.gov
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MeSH Terms
Descriptor/Qualifier:
Biological Products / biosynthesis*,  chemistry,  therapeutic use*
Drug Approval* / legislation & jurisprudence
Drug Design
Humans
Probiotics / standards*
United States
United States Food and Drug Administration / legislation & jurisprudence
Chemical
Reg. No./Substance:
0/Biological Products

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