Are acute toxicity studies required to support overdose for new medicines?

Regulatory Toxicology and Pharmacology

Volumn 55, Issue 1, 2009, Pages 110-

  Robinson, Sally ^a   Chapman, Kathryn ^b  

^a ASTRAZENECA   (United Kingdom)

^b National Centre for the Replacement   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ACUTE TOXICITY; BELGIUM; DRUG OVERDOSE; EUROPE; EVIDENCE BASED PRACTICE; FINLAND; GEORGIA (REPUBLIC); GERMANY; HUMAN; HUNGARY; LETTER; NETHERLANDS; NONHUMAN; POISON CENTER; PRIORITY JOURNAL; QUESTIONNAIRE; RISK ASSESSMENT; SLOVAKIA; SWITZERLAND; UNITED KINGDOM;

ACUTE TOXICITY TESTS; DRUG DESIGN; DRUGS, INVESTIGATIONAL; EVIDENCE-BASED MEDICINE; GUIDELINES AS TOPIC; HUMANS; MAXIMUM ALLOWABLE CONCENTRATION; OVERDOSE;

EID: 69249231966     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2009.06.012     Document Type: Letter

References (2)

1. Robinson S., et al. Regulatory Toxicology and Pharmacology 50 (2008) 345-352
2. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and marketing authorization for Pharmaceuticals M3(R2). Recommended for adoption at step 4 of the ICH process on June 11, 2009.