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169 results

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Page 1
Radium Ra 223 dichloride injection: U.S. Food and Drug Administration drug approval summary.
Kluetz PG, Pierce W, Maher VE, Zhang H, Tang S, Song P, Liu Q, Haber MT, Leutzinger EE, Al-Hakim A, Chen W, Palmby T, Alebachew E, Sridhara R, Ibrahim A, Justice R, Pazdur R. Kluetz PG, et al. Clin Cancer Res. 2014 Jan 1;20(1):9-14. doi: 10.1158/1078-0432.CCR-13-2665. Epub 2013 Nov 4. Clin Cancer Res. 2014. PMID: 24190979 Clinical Trial.
Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice.
Liu L, Choi J, Musoro JZ, Sauerbrei W, Amdal CD, Alanya A, Barbachano Y, Cappelleri JC, Falk RS, Fiero MH, Regnault A, Reijneveld JC, Sandin R, Thomassen D, Roychoudhury S, Goetghebeur E, le Cessie S; SISAQOL-IMI Work Package 3. Liu L, et al. Lancet Oncol. 2023 May;24(5):e197-e206. doi: 10.1016/S1470-2045(23)00110-9. Lancet Oncol. 2023. PMID: 37142381 Review.
Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.
Pe M, Alanya A, Falk RS, Amdal CD, Bjordal K, Chang J, Cislo P, Coens C, Dirven L, Speck RM, Fitzgerald K, Galinsky J, Giesinger JM, Holzner B, Le Cessie S, O'Connor D, Oliver K, Pawar V, Quinten C, Schlichting M, Ren J, Roychoudhury S, Taphoorn MJB, Velikova G, Wintner LM, Griebsch I, Bottomley A; SISAQOL-IMI Consortium. Pe M, et al. Lancet Oncol. 2023 Jun;24(6):e270-e283. doi: 10.1016/S1470-2045(23)00157-2. Lancet Oncol. 2023. PMID: 37269858 Free article. Review.
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary.
Kluetz PG, Ning YM, Maher VE, Zhang L, Tang S, Ghosh D, Aziz R, Palmby T, Pfuma E, Zirkelbach JF, Mehrotra N, Tilley A, Sridhara R, Ibrahim A, Justice R, Pazdur R. Kluetz PG, et al. Clin Cancer Res. 2013 Dec 15;19(24):6650-6. doi: 10.1158/1078-0432.CCR-13-2134. Epub 2013 Oct 22. Clin Cancer Res. 2013. PMID: 24150234 Clinical Trial.
Clinical trial design for the development of new therapies for nonmuscle-invasive bladder cancer: report of a Food and Drug Administration and American Urological Association public workshop.
Jarow JP, Lerner SP, Kluetz PG, Liu K, Sridhara R, Bajorin D, Chang S, Dinney CP, Groshen S, Morton RA, O'Donnell M, Quale DZ, Schoenberg M, Seigne J, Vikram B. Jarow JP, et al. Among authors: kluetz pg. Urology. 2014 Feb;83(2):262-4. doi: 10.1016/j.urology.2013.10.030. Epub 2013 Dec 12. Urology. 2014. PMID: 24332121
Drug and device development for localized prostate cancer: report of a Food and Drug Administration/American Urological Association public workshop.
Jarow JP, Thompson IM, Kluetz PG, Baxley J, Sridhara R, Scardino P, Carroll P, Albertsen P, Carter HB, Brawley O, Sartor O, Sandler H, Kiefert JJ, Morton RA Jr. Jarow JP, et al. Among authors: kluetz pg. Urology. 2014 May;83(5):975-8. doi: 10.1016/j.urology.2013.10.087. Epub 2014 Mar 22. Urology. 2014. PMID: 24661332
Reply by the authors.
Jarow J, Kluetz PG, Lerner SP, Liu K, Sridhara R, Bajorin D, Chang S, Dinney CP, Groshen S, Morton RA, O'Donnell M, Quale DZ, Schoenberg M, Seigne J, Vikram B. Jarow J, et al. Among authors: kluetz pg. Urology. 2014 Aug;84(2):495-6. doi: 10.1016/j.urology.2014.04.004. Urology. 2014. PMID: 25065996 No abstract available.
169 results