28-day repeated oral toxicity study of a hypolipidemic agent, NK-104 in rats

Journal of Toxicological Sciences

Volumn 23, Issue SUPPL. 5, 1998, Pages 701-711

  Akiba, Tomohide ^a   Shibuta, Tetsuo ^a   Amano, Yukinori ^a   Okubo, Masato ^a   Asanuma, Akimune ^a   Koga, Teruji ^a   Tanaka, Masahiro ^a   Takimoto, Masayoshi ^a  

^a KOWA COMPANY LTD   (Japan)

Author keywords

HMG CoA reductase inhibitor; Hypolipidemic agent; NK 104; Rat; Subacute toxicity

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CHOLESTEROL; CHOLINESTERASE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PITAVASTATIN; TRIACYLGLYCEROL;

ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BODY WEIGHT; DIARRHEA; FEMALE; FOOD INTAKE; HYPERKERATOSIS; HYPERTROPHY; MALE; MICROSCOPY; MUSCLE ATROPHY; MUSCLE NECROSIS; NONHUMAN; ORAL DRUG ADMINISTRATION; RAT; STOMACH MUCOSA; TOXICITY;

ANIMALIA; RATTUS NORVEGICUS;

EID: 0032414471     PISSN: 03881350     EISSN: 18803989     Source Type: Journal    
DOI: 10.2131/jts.23.supplementv_701     Document Type: Article

References (10)

1. Aoki, T., Nishimura, H., Nakagawa, S., Kojima, J., Suzuki, H., Tamaki, T., Wada, Y., Yokoo, N., Sato, F., Kimata, H., Kitahara, M., Toyoda, K., Sakashita, M. and Saito Y. (1997): Pharmacological Profile of a Novel Synthetic Inhibitor of 3-Hydroxy-3-methylglutaryl-coenzyme A Reductase. Arzneim.-Forsch./Drug Res., 47, 904-909.
2. FDA (1993): Summary basis of approval of NDA.
3. Gad, S. C. and Weil, C. S.(1984): Statistics for toxicologist, In Principles and methods of toxicology (Haye, A. W. ed.), Student ed., 273-320 Raven Press, New York.
4. Gerson, R. J., MacDonald, J. S., Lankas, G. R., Jensen, R. G., Bokelman, D. L., Usi, T., Ochiai, K. and Kemi, M.(1990): Toxicity study of Simvastatin(2):A 53-Week Oral Toxicity Study in Rats with A 27-Week Interim Necropsy, Oyo Yakuri/Pharmacometrics, 39, 103-126.
5. Kruskal, W. H. and Wallis, W. A.(1952): Use of ranks in one-criterion variance analysis. J. Am. Statist. Assoc., 47, 583-621.
6. Liscum, L., Luskey, K. L., Chin, D. J., Ho, Y. K., Goldstein, J. L. and Brown,M. S. (1983): Regulation of 3-hydroxy-3-methylglutaryl coenzyme A reductase and its mRNA in rat liver as studied with a monoclonal antibody and a cDNA probe. J. Biol. Chem., 258 , 8450-8455.
7. Nakahara, K. and Kuriyam, M.(1991): Safety of HMG-CoA reductase inhibitor-Basic study (in Japanese), Prog.Med., 11, 2499-2508.
8. Okubo, M., Akiba, T., Yagishita, K. and Masujima, Y.(1991): One-month consecutive oral toxicity study of a therapeutic for hyperlipemia(NK-104) in rats. Unpublished.
9. Shibuta, T., Okubo, M., Akiba, T., Yagishita, K. and Koga, T.(1992): Single oral toxicity study of NK-104 in rats, Unpublished.
10. Singer, I. I., Kawka, D. W., Scott, S., Bailey, P., Kloss, M. W., Majka, J. and MacDonald, J. S.(1991): Inhibition of 3-hydroxy-3-methylglutaryl coenzyme A reductase accumulation and altered lamellar bodies in rat forestomach keratinocytes. Arteriosclerosis and Thrombosis, II, 1156-1165.