The duration of non-rodent toxicity studies for pharmaceuticals

Toxicological Sciences

Volumn 49, Issue 2, 1999, Pages 143-155

  DeGeorge, Joseph J ^a   Meyers, Laraine L ^a   Takahashi, Michihito ^c   Contrera, Joseph F ^a,b  

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

^b Office of Testing and Research   (United States)

^c NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

Author keywords

Harmonization of international standards; Non rodent toxicity studies

Indexed keywords

ANTIANDROGEN; ANTIFUNGAL AGENT; BENZODIAZEPINE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; CHOLINESTERASE INHIBITOR; DIHYDROPYRIDINE DERIVATIVE; DOPAMINE RECEPTOR BLOCKING AGENT; HYPNOTIC AGENT; LOW MOLECULAR WEIGHT HEPARIN; NEUROPROTECTIVE AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; RECOMBINANT ERYTHROPOIETIN; SEROTONIN UPTAKE INHIBITOR;

ANIMAL EXPERIMENT; DOG; DOSE RESPONSE; DRUG SAFETY; EUROPEAN UNION; EXPERT SYSTEM; FEMALE; JAPAN; MALE; MONKEY; MORTALITY; NONHUMAN; ORAL DRUG ADMINISTRATION; REVIEW; TOXICITY TESTING; UNITED STATES;

ANIMALS; DRUG EVALUATION; DRUG TOXICITY; EUROPE; INTERNATIONAL AGENCIES; INTERNATIONAL COOPERATION; JAPAN; TIME FACTORS; TOXICITY TESTS; UNITED STATES;

ANIMALIA; CANIS FAMILIARIS; RODENTIA;

EID: 0033037422     PISSN: 10966080     EISSN: None     Source Type: Journal    
DOI: 10.1093/toxsci/49.2.143     Document Type: Review

References (6)

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2. Igarashi, T. (1993). A review of the Japanese Pharmaceutical Manufacturers Association database currently established to examine retrospectively the value of long-term animal toxicity studies. Adverse Drug React. Toxicol. Rev. 12, 35-52.
3. Lumley, C. E., Parkinson, C., and Walker, S. R. (1993). The value of the dog in long-term toxicity studies: The CMR international toxicology database. Adverse Drug React. Toxicol. Rev. 12, 53-62.
4. Parkinson, C., Lumley, C. E., and Walker, S. R. (1995). The value of information generated by long-term toxicity studies in the dog for nonclinical safety assessment of pharmaceutical compounds. Fundam. Appl. Toxicol. 25, 115-123.
5. Safholm, C., and Havu, N. (1993). General toxicity of the new calcium antagonist felodipine in dogs. Arzneimittelforschung 43, 729-733.
6. Waner, T., Nyska, A., Nyska, M., Pirak, M., Sela, M., and Galiano, A. (1988). Gingival hyperplasia in dogs induced by oxodipine, a calcium channel blocking agent. Toxicol. Pathol. 16, 327-332.