Animal-to-Human Dose Translation of Obiltoxaximab for Treatment of Inhalational Anthrax Under the US FDA Animal Rule

Clinical and Translational Science

Volumn 10, Issue 1, 2017, Pages 12-19

  Nagy, C F ^a   Mondick, J ^b   Serbina, N ^a   Casey, L S ^a   Carpenter, S E ^a   French, J ^b   Guttendorf, R ^c  

^a Elusys Therapeutics Inc   (United States)

^b Metrum Research Group LLC   (United States)

^c Aclairo Pharmaceutical Development Group Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIAL ANTIGEN; OBILTOXAXIMAB; PLACEBO; PROTECTIVE ANTIGEN; UNCLASSIFIED DRUG; ANTITOXIN; MONOCLONAL ANTIBODY;

ADAPTIVE IMMUNITY; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTHRAX; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN EXPERIMENT; MACACA FASCICULARIS; NEW ZEALAND WHITE (RABBIT); NONHUMAN; NORMAL HUMAN; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SIMULATION; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; UNITED STATES; ANIMAL; DOSE RESPONSE; LEPORIDAE; RESPIRATORY TRACT INFECTION; TIME FACTOR; TRANSLATIONAL RESEARCH;

ANIMALS; ANTHRAX; ANTIBODIES, MONOCLONAL; ANTITOXINS; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MACACA FASCICULARIS; RABBITS; RESPIRATORY TRACT INFECTIONS; TIME FACTORS; TRANSLATIONAL MEDICAL RESEARCH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85008263693     PISSN: 17528054     EISSN: 17528062     Source Type: Journal    
DOI: 10.1111/cts.12433     Document Type: Article

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