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Volumn 15, Issue 1, 2018, Pages 1-2
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The U.S. food and drug administration's experience with ivacaftor in cystic fibrosis: Establishing efficacy using in vitro data in lieu of a clinical trial
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Author keywords
CFTR; Chloride channels; Cystic fibrosis; Drug development
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Indexed keywords
CHLORIDE CHANNEL;
CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR;
IVACAFTOR;
AMINOPHENOL DERIVATIVE;
CFTR PROTEIN, HUMAN;
CHLORIDE CHANNEL STIMULATING AGENT;
QUINOLONE DERIVATIVE;
CHLORIDE TRANSPORT;
CLINICAL TRIAL (TOPIC);
CYSTIC FIBROSIS;
DRUG EFFICACY;
EXPERIENCE;
FOOD AND DRUG ADMINISTRATION;
GENE MUTATION;
HUMAN;
IN VITRO STUDY;
NONHUMAN;
REVIEW;
UNITED STATES;
CHEMISTRY;
DRUG APPROVAL;
DRUG DEVELOPMENT;
GENETICS;
MUTATION;
SWEAT;
AMINOPHENOLS;
CHLORIDE CHANNEL AGONISTS;
CLINICAL TRIALS AS TOPIC;
CYSTIC FIBROSIS;
CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR;
DRUG APPROVAL;
DRUG DEVELOPMENT;
HUMANS;
MUTATION;
QUINOLONES;
SWEAT;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
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EID: 85039797009
PISSN: 23256621
EISSN: None
Source Type: Journal
DOI: 10.1513/AnnalsATS.201708-668PS Document Type: Review |
Times cited : (102)
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References (6)
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