Are hepatic impairment studies necessary for therapeutic proteins?

Clinical Therapeutics

Volumn 35, Issue 9, 2013, Pages 1444-1451

  Yang, Jun ^a   Shord, Stacy ^a   Zhao, Hong ^a   Men, Yuxin ^a   Rahman, Atiqur ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Hepatic impairment; Pharmacokinetics; Therapeutic proteins

Indexed keywords

ABATACEPT; AFLIBERCEPT; ALEFACEPT; ALPHA2B INTERFERON; ALPHAN3 INTERFERON; ALTEPLASE; ASPARAGINASE; BASILIXIMAB; BELIMUMAB; BETA1A INTERFERON; BEVACIZUMAB; BRENTUXIMAB VEDOTIN; CETUXIMAB; COLLAGENASE; DENOSUMAB; DORNASE ALFA; DROTRECOGIN; ETANERCEPT; GALSULFASE; GAMMA1B INTERFERON; IDURONATE 2 SULFATASE; INTERFERON BETA SERINE; IPILIMUMAB; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PANITUMUMAB; RASBURICASE; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GLUCAN 1,4 ALPHA GLUCOSIDASE; TRASTUZUMAB EMTANSINE; UNINDEXED DRUG;

ARTICLE; FOOD AND DRUG ADMINISTRATION; HUMAN; LIVER DYSFUNCTION; LIVER FUNCTION; LIVER FUNCTION TEST; MEDLINE; PACKAGING; PHARMACOKINETICS; PHASE 3 CLINICAL TRIAL;

HEPATIC IMPAIRMENT; PHARMACOKINETICS; THERAPEUTIC PROTEINS;

ANTIBODIES, MONOCLONAL; CLINICAL TRIALS AS TOPIC; CYTOKINES; ENZYMES; HUMANS; IMMUNOTOXINS; LIVER DISEASES; MOLECULAR TARGETED THERAPY; PROTEINS; SINGLE-CHAIN ANTIBODIES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84884352348     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2013.06.010     Document Type: Article

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