Dose selection for carcinogenicity studies of pharmaceuticals: Systemic exposure to phenacetin at carcinogenic dosage in the rat

Regulatory Toxicology and Pharmacology

Volumn 28, Issue 3, 1998, Pages 226-229

  Bergman, K ^a   Olofsson, I M ^a   Sjoberg P ^a  

^a MEDICAL PRODUCTS AGENCY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

CARCINOGEN; PHENACETIN;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DOSE CALCULATION; DRUG BLOOD LEVEL; DRUG CARCINOGENICITY; DRUG EXPOSURE; DRUG MEGADOSE; FOOD AND DRUG ADMINISTRATION; MALE; MAXIMUM ALLOWABLE CONCENTRATION; NONHUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RAT;

ANIMALIA;

EID: 0032449819     PISSN: 02732300     EISSN: None     Source Type: Journal    
DOI: 10.1006/rtph.1998.1260     Document Type: Article

References (9)

1. Chiou W. L. Dose- and dosage form-dependent pharmacokinetics of phenacetin and its metabolite in man. J. Clin. Pharmacol. 14:1974;418-425.
2. Contrera J. F., Jacobs A. C., Prasanna H. R., Mehta M., Schmidt W. J., De George J. A systemic exposure-based alternative to the maximum tolerated dose for carcinogenicity studies of human therapeutics. J. Am. Coll. Toxicol. 14:1995;1-10.
3. Proceedings of the Second International Conference on Harmonisation. 1994;Queen's University of Belfast Press, Belfast. p. 7-1-7-8.
4. Johansson S. Carcinogenicity of analgesics: Long-term treatment of Sprague-Dawley rats with phenacetin, phenazone, caffeine and paracetamol (acetamidophen). Int. J. Cancer. 27:1981;521-529.
5. Mineshita S., Eggers R., Kitteringham N. R., Ohnhaus E. E. Determination of phemacetin and its major metabolites in human plasma and urine by high-performance liquid chromatography. J. Chromatogr. 380:1986;407-413.
6. Murai T., Mori S., Machino S., Hosono M., Takeuchi Y., Ohara T., Makino S., Takeda R., Hayashi Y., Iwata H., Yamamoto S., Ito H., Fukushima S. Induction of renal pelvic carcinoma by phenacetin in hydronephrosis-bearing rats of the SD/cShi strain. Cancer Res. 53:1993;4218-4223.
7. Prescott L. F., Steel R. F., Ferrier W. R. The effects of particle size on the absorption of phenacetin in man. Clin. Pharmacol. Ther. 11:1970;496-504.
8. Raaflaub J., Dubach U. C. On the pharmacokinetics of phenacetin in man. Eur. J. Clin. Pharmacol. 8:1975;261-265.
9. Welch R. M., Hughes C. R., DeAngelis R. L. Effect of 3-methylcholanthrene pretreatment on the bioavailability of phenacetin in the rat. Drug Metab. Dispos. 4:1976;402-406.