Model-Informed Development and Registration of a Once-Daily Regimen of Extended-Release Tofacitinib

Clinical Pharmacology and Therapeutics

Volumn 101, Issue 6, 2017, Pages 745-753

  Lamba, M ^a   Hutmacher, M M ^b   Furst, D E ^c   Dikranian, A ^d   Dowty, M E ^a   Conrado, D ^a   Stock, T ^a   Nduaka, C ^a   Cook, J ^a   Krishnaswami, S ^a  

^a PFIZER INC   (United States)

^b ANN ARBOR PHARMACOMETRICS GROUP   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d San Diego Arthritis Medical Clinic   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TOFACITINIB; ANTINEOPLASTIC AGENT; DELAYED RELEASE FORMULATION; JANUS KINASE; PIPERIDINE DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRIMIDINE DERIVATIVE; PYRROLE DERIVATIVE;

AREA UNDER THE CURVE; ARTICLE; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG EFFICACY; DRUG EXPOSURE; DRUG FORMULATION; EXTENDED RELEASE FORMULATION; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMEDIATE RELEASE FORMULATION; MINIMUM PLASMA CONCENTRATION; PHARMACEUTICAL EQUIVALENCE; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL (TOPIC); PREDICTIVE VALUE; PRIORITY JOURNAL; REGISTRATION; RHEUMATOID ARTHRITIS; ANIMAL; ANIMAL MODEL; ANTAGONISTS AND INHIBITORS; BIOLOGICAL MODEL; CHEMISTRY; COMPARATIVE STUDY; DELAYED RELEASE FORMULATION; DRUG ADMINISTRATION; DRUG APPROVAL; ENZYMOLOGY; MALE; METABOLIC CLEARANCE RATE; METABOLISM; NEOPLASMS; ORAL DRUG ADMINISTRATION; PATHOLOGY; SPRAGUE DAWLEY RAT; THERAPEUTIC EQUIVALENCE; TREATMENT OUTCOME; UNITED STATES;

ADMINISTRATION, ORAL; ANIMALS; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; DELAYED-ACTION PREPARATIONS; DRUG ADMINISTRATION SCHEDULE; DRUG APPROVAL; HUMANS; JANUS KINASES; MALE; METABOLIC CLEARANCE RATE; MODELS, ANIMAL; MODELS, BIOLOGICAL; NEOPLASMS; PIPERIDINES; PROTEIN KINASE INHIBITORS; PYRIMIDINES; PYRROLES; RATS, SPRAGUE-DAWLEY; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85012936863     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.576     Document Type: Article

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