Comparison of two guidelines on immunotoxicity testing of medicinal products

Arhiv za Higijenu Rada i Toksikologiju

Volumn 56, Issue 3, 2005, Pages 265-268

  Hanzl Dujmović, Ivana ^a,b  

^a Belupo dd   (Croatia)

^b Belupo Pharmaceuticals and Cosmetics   (Croatia)

Author keywords

Drugs; Immunotoxicology; Regulatory guidance; Tiered testing approach

Indexed keywords

COMPARATIVE STUDY; CONFERENCE PAPER; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; IMMUNOTOXICITY; PRACTICE GUIDELINE;

ANIMALS; GUIDELINES; IMMUNE SYSTEM; PHARMACEUTICAL PREPARATIONS; TOXICITY TESTS;

EID: 23944483688     PISSN: 00041254     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (7)

1. Dean JH, Hincks JR, Remandet B. Immunotoxicology assessment in the pharmaceutical industry. Toxicology Letters 1998;102-103:247-55.
2. Koller LD. A perspective on the progression of immunotoxicology. Toxicology 2001;160:105-10.
3. Hastings KL. Implications of the new FDA/CDER immunotoxicology guidance for drugs. International immunopharmacology 2002;2:1613-8.
4. Descotes J. From clinical to human toxicology: linking animal research and risk assessment in man. Toxicology Letters 2003;140-141:3-10.
5. Hastings KL. What are the prospects for regulation in immunotoxicology? Toxicology Letters 1998;102-103:267-70.
6. Committee For Proprietary Medicinal Product (Cpmp): Note For Guidance On Repeated Dose Toxicity, October 2000. Available from: http://www.emea.eu.int/ pdfs/human
7. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation Research (CDER): Guidance for Industry: Immunotoxicology Evaluation of Investigational New Drugs. Available from: http://www.fda.gov/CDER/ guidance