Appropriate Use of Recovery Groups in Nonclinical Toxicity Studies: Value in a Science-Driven Case-by-Case Approach

Veterinary Pathology

Volumn 49, Issue 2, 2012, Pages 357-361

  Pandher, K ^a   Leach, M W ^a   Burns Naas, L A ^a  

^a PFIZER INC   (United States)

Author keywords

nonclinical drug evaluation; nonclinical toxicology; preclinical toxicity study; recovery group; toxicity tests methods

Indexed keywords

BIOLOGICAL FACTOR;

ANIMAL; ARTICLE; DRUG SCREENING; HUMAN; METHODOLOGY; TOXICITY TESTING;

ANIMALS; BIOLOGICAL FACTORS; DRUG EVALUATION, PRECLINICAL; HUMANS; RESEARCH DESIGN; TOXICITY TESTS;

ANIMALIA;

EID: 84857672651     PISSN: 03009858     EISSN: 15442217     Source Type: Journal    
DOI: 10.1177/0300985811415701     Document Type: Article

References (4)

1. International Conference on Harmonisation. Topic M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. June 2009.
2. International Conference on Harmonisation. Topic S6 (R1): Preclinical Safety Evaluation of Biotechnology-Derived pharmaceuticals. Step 4. June, 2011
3. International Conference on Harmonisation. Topic S9: Nonclinical Evaluation for Anticancer Pharmaceuticals. March 2010
4. Olson H,Betton G,Robinson D, et al.Concordance of the toxicity of pharmaceuticals in humans and in animals.Regul Toxicol Pharmacol. 2000;32 (1): 56-67.