CARBOXYLIC ACID;
DRUG METABOLITE;
ENZALUTAMIDE;
N DESMETHYL ENZALUTAMIDE;
PLACEBO;
UNCLASSIFIED DRUG;
ANTINEOPLASTIC AGENT;
PHENYLTHIOHYDANTOIN;
ARTICLE;
BODY MASS;
CANCER PROGNOSIS;
CASTRATION RESISTANT PROSTATE CANCER;
CLEARANCE AT STEADY-STATE;
CONTROLLED STUDY;
DOUBLE BLIND PROCEDURE;
DRUG DISTRIBUTION;
DRUG DOSE ESCALATION;
DRUG EFFICACY;
DRUG EXCRETION;
DRUG HALF LIFE;
DRUG SAFETY;
DRUG TOLERABILITY;
DRUG TRANSFORMATION;
EQUILIBRIUM DIALYSIS;
HEPATIC CLEARANCE;
HUMAN;
LIVER FUNCTION;
MAJOR CLINICAL STUDY;
MALE;
MAXIMUM PLASMA CONCENTRATION;
MILD HEPATIC IMPAIRMENT;
MULTICENTER STUDY;
OPEN STUDY;
ORAL CLEARANCE;
OVERALL SURVIVAL;
PARALLEL DESIGN;
PHASE 1 CLINICAL TRIAL;
PHASE 3 CLINICAL TRIAL;
PLASMA CONCENTRATION-TIME CURVE;
PLASMA PROTEIN BINDING;
PRIORITY JOURNAL;
RANDOMIZED CONTROLLED TRIAL;
SINGLE DRUG DOSE;
TIME TO MAXIMUM PLASMA CONCENTRATION;
UNBOUND FRACTION;
URINALYSIS;
URINARY EXCRETION;
VOLUME OF DISTRIBUTION;
ADULT;
AGED;
ANALOGS AND DERIVATIVES;
BIOTRANSFORMATION;
BLOOD;
CLINICAL TRIAL;
DOSE RESPONSE;
DRUG ADMINISTRATION;
FOOD DRUG INTERACTION;
METABOLISM;
MIDDLE AGED;
PROSTATIC NEOPLASMS, CASTRATION-RESISTANT;
VERY ELDERLY;
Tran C, Ouk S, Clegg NJ, Chen Y, Watson PA, Arora V, et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science. 2009;324(5928):787–90.
Increased survival with enzalutamide in prostate cancer after chemotherapy
COI: 1:CAS:528:DC%2BC38XhsVKhsLvK, PID: 22894553
Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, AFFIRM Investigators, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13):1187–97.
(2012)N Engl J Med., vol.367, Issue.13, pp. 1187-1197
Enzalutamide in metastatic prostate before chemotherapy
PID: 24881730
Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, et al. Enzalutamide in metastatic prostate before chemotherapy. N Engl J Med. 2014;371(5):424–33.
US Department of Health and Human Services. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. 2000. Accessed 13 Feb 2015
US Department of Health and Human Services. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. 2000. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070246. Accessed 13 Feb 2015.
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77952105685
Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, et al. Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium. Antitumour activity of enzalutamide in castration-resistant prostate cancer: a phase 1-2 study. Lancet. 2010;24;375(9724):1437–46
Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, et al. Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium. Antitumour activity of enzalutamide in castration-resistant prostate cancer: a phase 1-2 study. Lancet. 2010;24;375(9724):1437–46.
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84942502762
US Department of Health and Human Services. Bioanalytical method validation. 2001. Accessed 13 Feb 2015
US Department of Health and Human Services. Bioanalytical method validation. 2001. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107. Accessed 13 Feb 2015.
7
84898718727
Validation of a method for quantifying enzalutamide and its major metabolites in human plasma by LC–MS/MS
Bennett D, Gibbons JA, Mol R, Ohtsu Y, Williard C. Validation of a method for quantifying enzalutamide and its major metabolites in human plasma by LC–MS/MS. Bioanalysis. 2014;6(6):737–44.
US Department of Health and Human Services. Food-effect bioavailability and fed bioequivalence studies. 2003. Accessed 13 Feb 2015
US Department of Health and Human Services. Food-effect bioavailability and fed bioequivalence studies. 2003. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/UCM126833. Accessed 13 Feb 2015.
9
85018117786
Pharmacokinetics in patients with impaired hepatic function: study design, data analysis
US Department of Health and Human Services. Pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling. 2005. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072123. Accessed 13 Feb 2015.
