A survey of new oncology drug approvals in the USA from 2010 to 2015: A focus on optimal dose and related postmarketing activities

Cancer Chemotherapy and Pharmacology

Volumn 77, Issue 3, 2016, Pages 459-476

  Lu, Dan ^a   Lu, Tong ^a   Stroh, Mark ^a   Graham, Richard A ^b   Agarwal, Priya ^a   Musib, Luna ^a   Li, Chi Chung ^a   Lum, Bert L ^a   Joshi, Amita ^a  

^a GENENTECH INC   (United States)

^b THERAVANCE INC   (United States)

Author keywords

Dose selection; Food and Drug Administration; Maximum tolerated dose; Modeling; Oncology; Pharmacodynamics; Pharmacokinetics

Indexed keywords

AFATINIB; AFLIBERCEPT; ANTINEOPLASTIC AGENT; ASPARAGINASE; AXITINIB; BOSUTINIB; BRENTUXIMAB VEDOTIN; CABOZANTINIB; CERITINIB; CRIZOTINIB; DABRAFENIB; DINUTUXIMAB; IBRUTINIB; IDELALISIB; IPILIMUMAB; LENVATINIB; NIVOLUMAB; OBINUTUZUMAB; PALBOCICLIB; PEMBROLIZUMAB; PERTUZUMAB; PONATINIB; RAMUCIRUMAB; REGORAFENIB; SILTUXIMAB; TRAMETINIB; TRASTUZUMAB EMTANSINE; UNINDEXED DRUG; VANDETANIB; VEMURAFENIB;

ARTICLE; DRUG APPROVAL; DRUG DOSE TITRATION; DRUG INDICATION; DRUG LABELING; HUMAN; OPTIMAL DRUG DOSE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; UNITED STATES; DOSE RESPONSE; FOOD AND DRUG ADMINISTRATION; MAXIMUM TOLERATED DOSE; MOLECULARLY TARGETED THERAPY; NEOPLASMS; PATHOLOGY;

ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG APPROVAL; HUMANS; MAXIMUM TOLERATED DOSE; MOLECULAR TARGETED THERAPY; NEOPLASMS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84959536249     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-015-2931-4     Document Type: Article

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