A global pharmaceutical company initiative: An evidence-based approach to define the upper limit of body weight loss in short term toxicity studies

Regulatory Toxicology and Pharmacology

Volumn 67, Issue 1, 2013, Pages 27-38

  Chapman, Kathryn ^a   Sewell, Fiona ^a   Allais, Linda ^b   Delongeas, Jean Luc ^c   Donald, Elizabeth ^d   Festag, Matthias ^e   Kervyn, Sophie ^f   Ockert, Deborah ^g   Nogues, Vicente ^h   Palmer, Helen ⁱ   Popovic, Marija ^j   Roosen, Wendy ^k   Schoenmakers, Ankie ^l   Somers, Kevin ^m   Stark, Claudia ⁿ   Stei, Peter ^o   Robinson, Sally ^p  

^a National Centre for the Replacement   (United Kingdom)

^b Ricerca Biosciences   (France)

^c INSTITUT DE RECHERCHES INTERNATIONALES SERVIER   (France)

^d Charles River   (United Kingdom)

^e Pharma Research and Early Development   (Switzerland)

^f UCB PHARMA   (Belgium)

^g Nycomed GmbH   (Germany)

^h NOVARTIS PHARMA AG   (Switzerland)

ⁱ HUNTINGDON LIFE SCIENCES   (United Kingdom)

^j ELI LILLY AND COMPANY   (United States)

^k JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^l WIL Research Europe BV   (Netherlands)

^m GLAXOSMITHKLINE   (United Kingdom)

ⁿ BAYER PHARMA AG   (Germany)

^o BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^p ASTRAZENECA   (United Kingdom)

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Author keywords

3Rs; Body weight loss (BWL); Dogs; Maximum tolerated dose (MTD); Non human primates (NHPs); Preclinical; Rats; Refinement; Regulatory toxicology; Short term toxicity study

Indexed keywords

ANTIINFLAMMATORY AGENT; ANTIMETABOLITE; HORMONE;

ANIMAL EXPERIMENT; ANIMAL WELFARE; ARTICLE; BODY WEIGHT; CARCINOGENICITY; CLINICAL ASSESSMENT; CLINICAL DECISION MAKING; CLINICAL FEATURE; CONTROLLED STUDY; DOG; DOSE RESPONSE; DRUG INDUSTRY; EVIDENCE BASED PRACTICE; FOLLOW UP; FOOD INTAKE; MAXIMUM TOLERATED DOSE; MEDICAL INFORMATION; NEPHROTOXICITY; NONHUMAN; OUTCOME ASSESSMENT; PRIMATE; PRIORITY JOURNAL; RAT; SAFETY; TOXICITY TESTING; TREATMENT DURATION; WEIGHT GAIN; WEIGHT REDUCTION;

ANIMALIA; CANIS FAMILIARIS; PRIMATES; RATTUS;

3RS; BODY WEIGHT LOSS; BODY WEIGHT LOSS (BWL); BWL; DOGS; MAXIMUM TOLERATED DOSE; MAXIMUM TOLERATED DOSE (MTD); MTD; NATIONAL CENTRE FOR THE REPLACEMENT, REFINEMENT AND REDUCTION OF ANIMALS IN RESEARCH; NC3RS; NHPS; NON-HUMAN PRIMATES; NON-HUMAN PRIMATES (NHPS); PRECLINICAL; RATS; REFINEMENT; REGULATORY TOXICOLOGY; REPLACEMENT, REDUCTION, REFINEMENT; SHORT TERM TOXICITY STUDY;

ANIMALS; BODY WEIGHT; DOGS; DRUG INDUSTRY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; MAXIMUM TOLERATED DOSE; PRIMATES; RATS; TOXICITY TESTS, ACUTE; WEIGHT LOSS;

EID: 84883457045     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2013.04.003     Document Type: Article

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