FDA comments on phase I clinical trials without vector biodistribution data [4]

Nature Genetics

Volumn 22, Issue 4, 1999, Pages 326-

  Epstein, S ^a   Bauer, S ^a   Miller, A ^a   Pilaro, A ^a   Noguchi, P ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

VIRUS VECTOR;

DISTRIBUTION VOLUME; FOOD AND DRUG ADMINISTRATION; GENE EXPRESSION; GENE INSERTION SEQUENCE; GENE MUTATION; GENE THERAPY; GONAD; LETTER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL;

CLINICAL TRIALS, PHASE I; GENE THERAPY; GENETIC VECTORS; GERM-LINE MUTATION; HUMANS; MUTAGENESIS, INSERTIONAL; TISSUE DISTRIBUTION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032769370     PISSN: 10614036     EISSN: None     Source Type: Journal    
DOI: 10.1038/11895     Document Type: Letter

References (3)