المؤلفون: Chang E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. elaine.chang@fda.hhs.gov., Weinstock C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhang L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhao M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zahalka E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fourie Zirkelbach J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Qiu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chen XH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Bhatnagar V; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Ibrahim A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

المصدر: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Feb 01; Vol. 28 (3), pp. 441-445. Date of Electronic Publication: 2021 Aug 20.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval*, Carcinoma, Renal Cell/*drug therapy , Kidney Neoplasms/*drug therapy , Phenylurea Compounds/*therapeutic use , Quinolines/*therapeutic use, Administration, Oral ; Adult ; Aged ; Aged, 80 and over ; Carcinoma, Renal Cell/mortality ; Female ; Humans ; Kidney Neoplasms/mortality ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Phenylurea Compounds/administration & dosage ; Phenylurea Compounds/adverse effects ; Quinolines/administration & dosage ; Quinolines/adverse effects ; Randomized Controlled Trials as Topic ; Sorafenib/administration & dosage ; Sorafenib/therapeutic use ; Survival Rate ; Treatment Outcome

المؤلفون: Narayan P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. preeti.narayan@fda.hhs.gov., Osgood CL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Singh H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chiu HJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chiu Yuen Chow E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Qiu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Song P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Namuswe F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Guiterrez-Lugo M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Hou S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pierce WF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Goldberg KB; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

المصدر: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Aug 15; Vol. 27 (16), pp. 4478-4485. Date of Electronic Publication: 2021 Mar 22.

نوع المنشور: Journal Article; Randomized Controlled Trial

بيانات الدورية: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval*, Breast Neoplasms/*drug therapy , Camptothecin/*analogs & derivatives , Immunoconjugates/*therapeutic use , Trastuzumab/*therapeutic use, Adult ; Aged ; Aged, 80 and over ; Breast Neoplasms/chemistry ; Camptothecin/therapeutic use ; Female ; Humans ; Middle Aged ; Receptor, ErbB-2/analysis ; United States

المؤلفون: Shah M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. mirat.shah@fda.hhs.gov., Wedam S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Cheng J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Xia H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fan J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Song P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chen W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chen XH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Gong Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pierce WF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

المصدر: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Mar 01; Vol. 27 (5), pp. 1220-1226. Date of Electronic Publication: 2020 Oct 14.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval*, Breast Neoplasms/*drug therapy , Oxazoles/*therapeutic use , Pyridines/*therapeutic use , Quinazolines/*therapeutic use , Receptor, ErbB-2/*metabolism, Antineoplastic Agents/therapeutic use ; Breast Neoplasms/metabolism ; Breast Neoplasms/secondary ; Female ; Humans ; United States ; United States Food and Drug Administration

المؤلفون: Chang E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. elaine.chang@fda.hhs.gov., Weinstock C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhang L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Charlab R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Dorff SE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gong Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Hsu V; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Song P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Waldron PE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zahalka E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Ibrahim A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

المصدر: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Feb 15; Vol. 27 (4), pp. 922-927. Date of Electronic Publication: 2020 Sep 22.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval*, Antibodies, Monoclonal/*administration & dosage , Carcinoma, Transitional Cell/*drug therapy , Urinary Bladder Neoplasms/*drug therapy, Antibodies, Monoclonal/adverse effects ; Carcinoma, Transitional Cell/diagnosis ; Carcinoma, Transitional Cell/secondary ; Drug Administration Schedule ; Humans ; Infusions, Intravenous ; Multicenter Studies as Topic ; Neoplasm Staging ; United States ; United States Food and Drug Administration/legislation & jurisprudence ; Urinary Bladder Neoplasms/diagnosis ; Urinary Bladder Neoplasms/pathology

المؤلفون: Shah A; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland. anand.shah@fda.hhs.gov., Bloomquist E; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Fu W; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Bi Y; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Liu Q; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Zhao P; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Palmby TR; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Goldberg KB; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Chang CJG; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Patel P; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Alebachew E; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Tilley A; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Pierce WF; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Ibrahim A; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Blumenthal GM; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Sridhara R; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, Silver Spring, Maryland.

المصدر: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2018 Jul 01; Vol. 24 (13), pp. 2999-3004. Date of Electronic Publication: 2018 Feb 07.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , Postmenopause*, Aminopyridines/*therapeutic use , Antineoplastic Agents/*therapeutic use , Breast Neoplasms/*drug therapy , Breast Neoplasms/*metabolism , Purines/*therapeutic use , Receptor, ErbB-2/*metabolism , Receptors, Estrogen/*metabolism , Receptors, Progesterone/*metabolism, Aminopyridines/administration & dosage ; Aminopyridines/adverse effects ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Breast Neoplasms/diagnosis ; Breast Neoplasms/mortality ; Clinical Trials as Topic ; Female ; Humans ; Neoplasm Metastasis ; Neoplasm Staging ; Protein Kinase Inhibitors/administration & dosage ; Protein Kinase Inhibitors/adverse effects ; Protein Kinase Inhibitors/therapeutic use ; Purines/administration & dosage ; Purines/adverse effects ; Research Design ; Treatment Outcome

المؤلفون: Balasubramaniam S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. sanjeeve.balasubramaniam@fda.hhs.gov., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Horton S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fernandes LL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Horne HN; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Liu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Liu C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Schrieber SJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Song P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pierce W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Robertson KJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Palmby TR; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chiu HJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Lee EY; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Philip R; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Schuck R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Charlab R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Banerjee A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chen XH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Wang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Goldberg KB; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Sridhara R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Kim G; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

المصدر: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2017 Dec 01; Vol. 23 (23), pp. 7165-7170. Date of Electronic Publication: 2017 Jul 27.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , Genes, BRCA1* , Genes, BRCA2* , Mutation*, Indoles/*therapeutic use , Ovarian Neoplasms/*drug therapy, Clinical Trials as Topic ; Female ; Humans ; Multicenter Studies as Topic ; Ovarian Neoplasms/genetics ; Ovarian Neoplasms/pathology ; Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use ; Retrospective Studies ; Treatment Outcome ; United States ; United States Food and Drug Administration

المؤلفون: Marcus L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland. leigh.marcus@fda.hhs.gov., Lemery SJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Khasar S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Wearne E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Helms WS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Yuan W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., He K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Cao X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Zhao H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Wang Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Stephens O; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Englund E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Agarwal R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Keegan P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.

المصدر: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2017 Jun 15; Vol. 23 (12), pp. 2924-2927. Date of Electronic Publication: 2017 Feb 17.

نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial

بيانات الدورية: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval*, Colorectal Neoplasms/*drug therapy , Drug Resistance, Neoplasm/*drug effects , Trifluridine/*administration & dosage , Uracil/*analogs & derivatives, Adult ; Aged ; Colorectal Neoplasms/pathology ; Disease-Free Survival ; Drug Combinations ; Drug-Related Side Effects and Adverse Reactions/classification ; Drug-Related Side Effects and Adverse Reactions/pathology ; Female ; Humans ; Male ; Middle Aged ; Pyrrolidines ; Thymine ; Trifluridine/adverse effects ; United States ; United States Food and Drug Administration ; Uracil/administration & dosage ; Uracil/adverse effects

المؤلفون: Mehrotra N; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland nitin.mehrotra@fda.hhs.gov., Bhattaram A; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Earp JC; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Florian J; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Krudys K; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Lee JE; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Lee JY; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Liu J; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Mulugeta Y; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhao P; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Sinha V; Division of Pharmacometrics, Office of Clinical Pharmacology (N.M., A.B., J.C.E., J.F., K.K., J.E.L., J.L., Y.M., J.Y., P.Z., V.S.), and Division of Biometrics VII, Office of Biostatistics (J.Y.L.), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

المصدر: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2016 Jul; Vol. 44 (7), pp. 924-33. Date of Electronic Publication: 2016 Apr 14.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: American Society for Pharmacology and Experimental Therapeutics, etc.] Country of Publication: United States NLM ID: 9421550 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1521-009X (Electronic) Linking ISSN: 00909556 NLM ISO Abbreviation: Drug Metab Dispos Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , Drug Dosage Calculations* , Drug Labeling* , Pharmacokinetics*, Pharmaceutical Preparations/*administration & dosage , Pharmaceutical Preparations/*metabolism, Adalimumab/administration & dosage ; Adalimumab/pharmacokinetics ; Adolescent ; Adolescent Development ; Adult ; Age Factors ; Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/pharmacokinetics ; Anti-Inflammatory Agents/administration & dosage ; Anti-Inflammatory Agents/pharmacokinetics ; Anticonvulsants/administration & dosage ; Anticonvulsants/pharmacokinetics ; Child ; Child Development ; Child, Preschool ; Crohn Disease/drug therapy ; Dose-Response Relationship, Drug ; Esomeprazole/administration & dosage ; Esomeprazole/pharmacokinetics ; Gastroesophageal Reflux/drug therapy ; HIV Infections/drug therapy ; Humans ; Infant ; Infant, Newborn ; Models, Biological ; Proton Pump Inhibitors/administration & dosage ; Proton Pump Inhibitors/pharmacokinetics ; Seizures/drug therapy ; Vigabatrin/administration & dosage ; Vigabatrin/pharmacokinetics

SCR Disease Name: Pediatric Crohn's disease

المؤلفون: Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland. Julia.Beaver@fda.hhs.gov., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Charlab R; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Chen W; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Palmby T; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Tilley A; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Zirkelbach JF; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Liu Q; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Zhao L; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Crich J; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Chen XH; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Hughes M; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Bloomquist E; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Sridhara R; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Kluetz PG; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Kim G; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Ibrahim A; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland., Cortazar P; Center for Drug Evaluation and Research, U.S. Food and Drug, Administration, White Oak, Maryland.

المصدر: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2015 Nov 01; Vol. 21 (21), pp. 4760-6. Date of Electronic Publication: 2015 Aug 31.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , United States Food and Drug Administration*, Antineoplastic Agents/*therapeutic use , Breast Neoplasms/*drug therapy , Piperazines/*therapeutic use , Protein Kinase Inhibitors/*therapeutic use , Pyridines/*therapeutic use, Animals ; Antineoplastic Agents/chemistry ; Antineoplastic Agents/pharmacology ; Breast Neoplasms/metabolism ; Breast Neoplasms/mortality ; Breast Neoplasms/pathology ; Clinical Trials as Topic ; Female ; Humans ; Neoplasm Metastasis ; Patient Selection ; Postmenopause ; Protein Kinase Inhibitors/chemistry ; Protein Kinase Inhibitors/pharmacology ; Receptor, ErbB-2/metabolism ; Receptors, Estrogen/metabolism ; Research Design ; Treatment Outcome ; United States

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