Accurate prediction of human drug toxicity: A major challenge in drug development

Chemico-Biological Interactions

Volumn 150, Issue 1, 2004, Pages 3-7

  Li, Albert P ^a  

^a Advanced Pharmaceutical Sciences   (United States)

Author keywords

Box warnings; Drug development; Drug safety; Drug safety evaluation; Drug withdrawal; FDA regulations; Human drug toxicity; Toxic mechanisms

Indexed keywords

ALOSETRON; ANTINEOPLASTIC AGENT; BIZELESIN; BROMFENAC; CERIVASTATIN; CISAPRIDE; DEXFENFLURAMINE; GREPAFLOXACIN; ISOTRETINOIN; LEFLUNOMIDE; LEVACETYLMETHADOL; MIBEFRADIL; NEVIRAPINE; RACHELMYCIN; RAPACURONIUM BROMIDE; REPAGLINIDE; RISPERIDONE; TROGLITAZONE;

BRONCHOSPASM; CARDIOTOXICITY; DEFORMITY; DRUG SAFETY; DRUG WITHDRAWAL; HEART ARRHYTHMIA; HUMAN; ISCHEMIC COLITIS; LIVER TOXICITY; REVIEW; RHABDOMYOLYSIS; RISK FACTOR; SIDE EFFECT; SPECIES DIFFERENCE; STROKE; TOXICITY TESTING; VALVULAR HEART DISEASE;

EID: 7444222283     PISSN: 00092797     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cbi.2004.09.008     Document Type: Article

References (7)

1. K.E. Lasser, P.D. Allen, S.J. Woolhandler, D.U. Himmelstein, S.M. Wolfe, and D. Bor Timing of new black box warnings and withdrawals for prescription medications J. Am. Med. Assoc. 287 2002 2215 2220
2. J.A. Dimasi, R.W. Hansen, and H.G. Grabowski The price of innovation: new estimates of drug development costs J. Health Econ. 22 2003 151 185
3. J.A. DiMasi The value of improving the productivity of the drug development process: faster times and better decisions Pharmacoeconomics 20 Suppl. 3 2002 1 10
4. J. Easterbrook, D. Fackett, and A.P. Li A comparison of aroclor 1254-induced and uninduced rat liver microsomes to human liver microsomes in phenytoin O-deethylation, coumarin 7-hydroxylation, tolbutamide 4-hydroxylation, S-mephenytoin 4′-hydroxylation, chloroxazone 6-hydroxylation and testosterone 6-beta-hydroxylation Chem. Biol. Interact. 134 2001 243 249
5. D.A. Volpe, J.E. Tomaszewski, R.E. Parchment, A. Garg, K.P. Flora, M.J. Murphy, and C.K. Grieshaber Myelotoxic effects of the bifunctional alkylating agent bizelesin on human, canine and murine myeloid progenitor cells Cancer Chemother. Pharmacol. 39 1996 143 149
6. A.P. Li A review of the common properties of drugs with idiosyncratic hepatotoxicity and the "multiple determinant hypothesis" for the manifestation of idiosyncratic drug toxicity Chem. Biol. Interact. 142 2002 7 23
7. J.F. Borzelleca Paracelsus: herald of modern toxicology Toxicol. Sci. 53 2000 2 4