Preclinical development strategies for novel gene therapeutic products

Toxicologic Pathology

Volumn 27, Issue 1, 1999, Pages 4-7

  Pilaro, Anne M ^a   Serabian, Mercedes A ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Adenovirus; Animal studies; Genetic disease; Plasmid DNA; Vector

Indexed keywords

PLASMID DNA;

CLONING VECTOR; CONFERENCE PAPER; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; LICENSING; MEDICAL RESEARCH; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT;

ADENOVIRIDAE; ANIMALIA;

EID: 0033012742     PISSN: 01926233     EISSN: None     Source Type: Journal    
DOI: 10.1177/019262339902700102     Document Type: Conference Paper

References (4)

1. Food and Drug Administration, Center for Biologies Evaluation and Research (1991). Points to consider in human somatic cell therapy and gene therapy. Available at: http://www.fda.gov/cber.
2. Food and Drug Administration, Center for Biologies Evaluation and Research (December 1996). Points to consider on plasmid DNA vaccines for preventive infectious disease indications. Fed. Register 61: 68269. Available at: http://www.fda.gov/cber.
3. Food and Drug Administration, Center for Biologies Evaluation and Research (March 1998). Guidance for industry: Guidance for human somatic cell therapy and gene therapy. Available at: http://www.fda.gov/cber.
4. National Institutes of Health, Office of Recombinant DNA Activities (May 1998). Quarterly report on human gene transfer protocols. Available at: http://www.nih.gov/od/orda/protocol.htm.