Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products

European Journal of Pharmacology

Volumn 759, Issue , 2015, Pages 51-62

  Cavagnaro, Joy ^a   Silva Lima, Beatriz ^b  

^a Access BIO   (United States)

^b RESEARCH INSTITUTE FOR MEDICINES IMED ULISBOA   (Portugal)

Author keywords

3Rs; Animal model; Critical Path Initiative; Disease model; Guidelines; ICH; In vitro; In vivo; Induced pluripotent stem cells; Innovative Medicines Initiative; Preclinical safety assessment; Predictive value; Regulatory guidance; Species selection

Indexed keywords

ADVERSE DRUG REACTION; ANIMAL; ANIMAL TESTING ALTERNATIVE; CLINICAL TRIAL (TOPIC); DISEASE MODEL; EUROPE; GOVERNMENT REGULATION; HUMAN; LEGISLATION AND JURISPRUDENCE; PRACTICE GUIDELINE; PRECLINICAL STUDY; PROCEDURES; SPECIES DIFFERENCE; TOXICITY TESTING; TRANSLATIONAL RESEARCH; UNITED STATES;

ANIMAL USE ALTERNATIVES; ANIMALS; CLINICAL TRIALS AS TOPIC; DISEASE MODELS, ANIMAL; DRUG EVALUATION, PRECLINICAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; SPECIES SPECIFICITY; TOXICITY TESTS; TRANSLATIONAL MEDICAL RESEARCH; UNITED STATES;

EID: 84937759731     PISSN: 00142999     EISSN: 18790712     Source Type: Journal    
DOI: 10.1016/j.ejphar.2015.03.048     Document Type: Review

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