Regulatory considerations for novel gene therapy products: A review of the process leading to the first clinical lentiviral vector

Human Gene Therapy

Volumn 16, Issue 1, 2005, Pages 17-25

  Manilla, Peter ^a,d   Rebello, Tessio ^a   Afable, Cathleen ^a   Lu, Xiaobin ^a   Slepushkin, Vladimir ^a   Humeau, Laurent M ^a   Schonely, Kathy ^a   Ni, Yajin ^a   Binder, Gwendolyn K ^a   Levine, Bruce L ^b   Macgregor, Rob Roy ^b   June, Carl H ^b   Dropulic, Boro ^c  

^a VIRxSYS Corporation   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c Lentigen Corporation   (United States)

^d NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LENTIVIRUS VECTOR;

CARCINOGENESIS; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; HEALTH CARE ORGANIZATION; LENTIVIRINAE; MEDICAL RESEARCH; NONHUMAN; PATIENT MONITORING; PRACTICE GUIDELINE; REVIEW; VIRUS REPLICATION;

BIOMEDICAL AND BEHAVIORAL RESEARCH; GENETICS AND REPRODUCTION; LEGAL APPROACH;

BIOMEDICAL RESEARCH; CLINICAL TRIALS; GENE THERAPY; GENETIC VECTORS; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; HUMANS; LENTIVIRUS; NEOPLASMS;

EID: 20844455902     PISSN: 10430342     EISSN: None     Source Type: Journal    
DOI: 10.1089/hum.2005.16.17     Document Type: Review

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