Regulatory perspectives of Type II prodrug development and time-dependent toxicity management: Nonclinical Pharm/Tox analysis and the role of comparative toxicology

Toxicology

Volumn 236, Issue 1-2, 2007, Pages 1-6

  Wu, Kuei Meng ^a   Farrelly, James G ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

AMPRENAVIR PHOSPHATE; BAMBUTEROL; CAPTOPRIL; CYCLOPHOSPHAMIDE; ETOPOFOS; FEXOFENADINE; FLUOROURACIL; FOSPHENYTOIN SODIUM; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; KETOCONAZOLE; LOPERAMIDE 1 OXIDE; PRODRUG; SALAZOSULFAPYRIDINE; TERFENADINE; TYPE 1 PRODRUG; TYPE 2 PRODRUG; UNCLASSIFIED DRUG; VALGANCICLOVIR; ZIDOVUDINE;

ANEMIA; AREA UNDER THE CURVE; ARTICLE; BLOOD CLOTTING DISORDER; BLOOD TOXICITY; BONE MARROW SUPPRESSION; DIARRHEA; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG DESIGN; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG INFORMATION; DRUG METABOLISM; DRUG SAFETY; DRUG TRANSFORMATION; ERYTHROPENIA; GASTROINTESTINAL TOXICITY; HUMAN; HYPERTROPHY; LIVER INJURY; NEPHROTOXICITY; NONHUMAN; PRIORITY JOURNAL; QT PROLONGATION; SIDE EFFECT; SUDDEN DEATH; TORSADE DES POINTES; TOXICITY; VOMITING;

ANIMALS; DRUGS, INVESTIGATIONAL; PRODRUGS; TIME FACTORS; TOXICOLOGY;

ANIMALIA;

EID: 34248669587     PISSN: 0300483X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tox.2007.04.005     Document Type: Article

References (7)

1. AHFS Drug Information. 2007. ASHP (corporate author): American Society of Health-System Pharmacists. Bethesda, Maryland.
2. Brunton L., Lazo J., and Parker K. Goodman & Gilman's the Pharmacological Basis of Therapeutics. 11th edition (2005), McGraw-Hill, New York
3. Goldstein A., Aronow L., and Kalman S. Principles of Drug Action. 2nd edition (1974), John Wiley & Sons, New Jersey
4. Wu K.M., Farrelly J., Birncrant D., Chen S., Dou J., Aisar Atrakchi A., Bigger A., Chen C., Chen Z., Freed L., Ghantous H., Goheer A., Hausner E., Osterberg R., Rhee H., and Zhang K. Regulatory Toxicology Perspectives on the Development of Botanical Drug Products in the United States. Am. J. Ther. 11 (2004) 213-217
5. Wu, K.M., Farrelly, J. 2005. Monitoring Time-Dependent Emergence of Drug Toxicity: Use of a Spreadsheet Presentation in Toxicity Management FDA Science Forum 1:41.(B-10).
6. Wu K.M., and Farrelly J. Preclinical Development of New Drugs that Enhance Thyroid Hormone Metabolism and Clearance: Inadequacy of Using Rats as an Animal Model for Predicting Human Risks in an IND and NDA. Amer. J. Therap. 13 (2006) 141-144
7. Wu, K.M., Farrelly, J. 2006b. Regulatory Perspectives of Type II Prodrug Development: Preclinical Pharm/Tox Analysis and the Role of Comparative Toxicology. FDA Science Forum 1:134.(K-44).