CDER photosafety guidance for industry

Toxicologic Pathology

Volumn 32, Issue SUPPL. 2, 2004, Pages 17-18

  Jacobs, Abigail C ^a   Brown, Paul C ^a   Chen, Conrad ^a   Ellis, Amy ^a   Farrelly, James ^a   Osterberg, Robert ^a  

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

Author keywords

CDER guidance; Photoirritation; Photosensitivity

Indexed keywords

APOPTOSIS; CONFERENCE PAPER; ERYTHEMA; FOOD AND DRUG ADMINISTRATION; GENOTOXICITY; KERATINOCYTE; OCCUPATIONAL SAFETY; PHOTOALLERGY; PHOTODYNAMIC THERAPY; PHOTOSENSITIVITY; PRIORITY JOURNAL; SKIN TEST; SUNBURN; TOPICAL TREATMENT; ULTRAVIOLET RADIATION;

3T3 CELLS; ACUTE TOXICITY TESTS; ANIMALS; DRUG EVALUATION; GUIDELINES; INDUSTRY; MICE; PHOTOSENSITIZING AGENTS; SAFETY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 3342901762     PISSN: 01926233     EISSN: None     Source Type: Journal    
DOI: 10.1080/01926230490463821     Document Type: Conference Paper

References (5)

1. Anderson, R. R., and Parrish, J. A. (1981). The optics of human skin. J Invest Dermatol 77, 13-19.
2. CDER/FDA. (2003). 2003 Guidance for Industry Photosafety Testing. (http://www.fda.gov/cder/guidance/index.htm).
3. de Gruijl, F. R., and Forbes, P. D. (1995). UV-induced skin cancer in a hairless mouse model. Bioassays 17(7), 651-60.
4. Jacobs, A., Avalos, J., Brown, P., and Wilkin, J. (1999). Does photosensitivity predict photococarcinogenicity? Inter J Toxicol 187(4), 191-8.
5. Spielmann, H., Balls, M., Dupuis, J., Pape, W. J., Pechovitch, G., de Silva, O., Holzhütter, H. G., Clothier, R., Desolle, P., Gerberick, F., Liebsch, M., Lovell, W. W., Maurer, T., Pfannenbecker, U., Potthast, J. M., Csato, M., Sladowski, D., Steiling, W., and Brantom, P. (1998). The International EU/COLIPA in Vitro Phototoxicity Validation Study: Results of Phase II (Blind Trial): Part 1: The 3T3 NRU Phototoxicity Test. Toxicology in Vitro 12(3), 305-27.