Successful drug development despite adverse preclinical findings

Journal of Toxicologic Pathology

Volumn 23, Issue 4, 2010, Pages 213-234

  Ettlin, Robert A ^a   Kuroda, Junji ^b   Plassmann, Stephanie ^c   Hayashi, Makoto ^d   Prentice, David E ^c  

^a Ettlin Consulting Ltd   (Switzerland)

^b KISSEI PHARMACEUTICAL CO LTD   (Japan)

^c PreClinical Safety (PCS) Consultants Ltd   (Japan)

^d Biosafety Research Center   (Japan)

Author keywords

Adverse preclinical finding; Carcinogenicity; Genotoxicity; Morphologic toxicity; Reproductive toxicity; Weight of evidence approach

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; 6,7 DIMETHOXY 3 METHYL 1 3',5' BIS(METHOXYETHOXY)PHENYL ISOQUINOLINE; ADENOSINE RECEPTOR STIMULATING AGENT; ARIPIPRAZOLE; BROMOCRIPTINE; CALCITONIN; DOPAMINE RECEPTOR STIMULATING AGENT; ENDOTHELIN RECEPTOR ANTAGONIST; ENTACAPONE; ISOPRENALINE; ISOQUINOLINE DERIVATIVE; LISURIDE; MESULERGINE; MINOXIDIL; MITOGEN ACTIVATED PROTEIN KINASE INHIBITOR; MURAGLITAZAR; NALIDIXIC ACID; PARACETAMOL; PERGOLIDE; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR AGONIST; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR ALPHA; POTASSIUM CHANNEL STIMULATING AGENT; PRAMIPEXOLE; PREGABALIN; RIBAVIRIN; SALCATONIN; TEGASEROD; TRANEXAMIC ACID; UNCLASSIFIED DRUG; VASCULOTROPIN INHIBITOR;

ANGIONEUROTIC EDEMA; BONE DISEASE; BONE MINERALIZATION; CARDIOTOXICITY; DIABETES MELLITUS; DRUG MEGADOSE; DRUG RESEARCH; DRUG SAFETY; DYSLIPIDEMIA; ENDOCRINE TUMOR; GASTROINTESTINAL DISEASE; GENOTOXICITY; HEPATITIS C; HUMAN; HYPERCALCEMIA; HYPERPROLACTINEMIA; HYPERTHYROIDISM; HYPERTROPHIC OSTEOPATHY; HYPOPHYSIS TUMOR; INSULIN RESISTANCE; IRRITABLE COLON; LEYDIG CELL TUMOR; LIPIDOSIS; LIVER TOXICITY; LOW DRUG DOSE; NEPHROTOXICITY; NEUROPATHIC PAIN; NEUROTOXICITY; NONHUMAN; PARKINSON DISEASE; PSYCHOSIS; REVIEW; RHABDOMYOLYSIS; SINGLE DRUG DOSE; TOXICITY TESTING; TREATMENT DURATION; TREATMENT INDICATION; URINARY TRACT INFECTION; UTERUS TUMOR; VASCULITIS;

EID: 78650994552     PISSN: 09149198     EISSN: None     Source Type: Journal    
DOI: 10.1293/tox.23.213     Document Type: Review

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