Member since Feb '11 Working languages: English to Turkish Turkish (monolingual) Turkish to English Availability today: | February 2012 | | | S | M | T | W | T | F | S | | | | | 1 | 2 | 3 | 4 | | 5 | 6 | 7 | 8 | 9 | 10 | 11 | | 12 | 13 | 14 | 15 | 16 | 17 | 18 | | 19 | 20 | 21 | 22 | 23 | 24 | 25 | | 26 | 27 | 28 | 29 | | | | |
| Tuncay Kurt Medical Translation; Experience-Quality! Istanbul, Istanbul, Turkey Local time: 15:23 EET (GMT+2)
Native in: Turkish | | |
Medical Translation; High Quality & Fast Turnaround! | Freelancer, Verified member | | Translation, Editing/proofreading, Post-editing | | Specializes in: | | Medical: Instruments | Medical: Pharmaceuticals | | Medical: Health Care | Medical: Dentistry | | Medical (general) | Medical: Cardiology | | English to Turkish - Rates: 0.05 - 0.07 EUR per word / 25 - 35 EUR per hour Turkish to English - Rates: 0.05 - 0.07 EUR per word / 25 - 35 EUR per hour | | EUR | | PRO-level points: 138, Questions answered: 84, Questions asked: 177 | 8 entries More Less | | Wire transfer, Moneybookers, PayPal | Sample translations submitted: 1 English to Turkish: Overall Summary of XXX Clinical Program General field: Medical Detailed field: Medical: Pharmaceuticals | Source text - English The xxx clinical development program for the treatment of patients with advanced malignances involving bone to prevent SREs is supported by 3 pivotal, international, phase 3, randomized, double blind, active controlled studies designed to determine if xxx is noninferior (primary endpoint) or superior (secondary endpoint, tested only after noninferiority was demonstrated) to zoledronic acid (Zometa®) with respect to preventing or delaying the first on-study occurrence of an SRE and whether xxx was superior to zoledronic acid in delaying the time to first and subsequent on-study SRE in either adults with advanced breast cancer and bone metastases (Study 20050136); adults with other solid tumors (excluding breast and prostate cancer) and bone metastases or multiple myeloma (Study 20050244), or men with hormone refractory (castrate-resistant) prostate cancer and bone metastases (Study 20050103). While these studies enrolled populations with different tumor types, they were consistent in terms of study design, endpoints, and statistical methodology. Zoledronic acid was chosen as the active comparator because it is the most potent bisphosphonate (Gutta and Louis, 2007) broadly licensed for use across the cancer types evaluated in these studies (Table 1) and is generally the most frequently prescribed IV bisphosphonate in patients with advanced cancer.
These studies were similar in terms of endpoint definitions (ie, reduction or prevention of the occurrence of SREs; the composite endpoint of SREs was the same in both the xxx and zoledronic acid registrational studies), statistical methods, subject population, and dose and administration of zoledronic acid to the zoledronic acid registrational studies in advanced cancer, as discussed in Section 4.1. | Translation - Turkish Kemikte metastaz yapan ilerlemiş maligniteli hastaların tedavisinde SRE’lerin önlenmesi için xxx klinik geliştirme programı, çalışmada ilk SRE gelişiminin önlenmesi veya geciktirilmesi açısından xx'in zoledronik aside (yyy®) eşdeğer olup olmadığı (primer sonlanma noktası) veya zoledronik asitten üstün olup olmadığının (sekonder sonlanma noktası, sadece eşdeğerlik gösterildikten sonra test edilmiştir) belirlenmesi ve xx'in, ilerlemiş meme kanseri ve kemik metastazı bulunan erişkinlerde (Çalışma 20050136), diğer solid tümörler (meme ve prostat kanseri hariç) ve kemik metastazı veya multipl myelom bulunan erişkinlerde (Çalışma 20050244) veya hormona dirençli (kastrasyona dirençli) prostat kanseri ve kemik metastazı bulunan erkeklerde (Çalışma 20050103), çalışmada ilk ve sonraki SRE meydana gelene kadar geçen sürenin geciktirilmesi açısından zoledronik asitten üstün olup olmadığının belirlenmesi amacıyla tasarlanan 3 öncü, uluslararası, faz 3, randomize, çift kör, aktif kontrollü çalışma ile desteklenmiştir. Bu çalışmalar, farklı tümör tipleri olan popülasyonların dahil edilmesine karşın çalışma tasarımı, sonlanma noktaları ve istatistik metodoloji açısından uyumluydu. Zoledronik asit bu çalışmalarda değerlendirilen kanser tiplerinde büyük ölçüde ruhsatlandırılmış, en potent bifosfonat (Gutta ve Louis, 2007) (Tablo 1) ve genelde ilerlemiş kanseri hastalarda en yaygın reçete dilen IV bifosfonat olması nedeniyle aktif karşılaştırma ilacı olarak seçilmiştir.
Bu çalışmalar sonlanma noktaları (yani, SRE’lerin önlenmesi veya insidansının azaltılması, SRE’lerin birleşik sonlanma noktası xxx ve zoledronik asit ruhsatlandırma çalışmalarında aynıydı), istatistiksel metotlar, hasta popülasyonu açısından Bölüm 4.1’de ele alındığı gibi ilerlemiş kanserde yapılan zoledronik asit ruhsatlandırma çalışmalarındaki zoledronik asit doz ve uygulama şeklinde benzerdi. | More Less | | Bachelor's degree - Cumhuriyet University | | Years of translation experience: 7. Registered at ProZ.com: Feb 2005. Became a member: Feb 2011. | | N/A | Turkish to English (Cumhuriyet University) English to Turkish (Cumhuriyet University) | | N/A | | Microsoft Excel, Microsoft Word, MS Office, SubTitle Workshop, Powerpoint, SDL TRADOS, SDLX, Wordfast | | Tuncay Kurt endorses ProZ.com's Professional Guidelines. | | About me * 6 years experience in translation
* Sound experience in mainly medical texts
* Particular experience in pharmaceuticals
Participated in a joint-translation project to translate/publish "The Pillow Book of Sei Shonagon / Yastıkname" The Pillow Book
Recet projects mainly include:
*Clinical / Non-Clinical Reviews,
*Study Reports,
*Common Technical Documents,
*Overall Quality Reviews,
*Marketing Authorizations,
*Summary of Drug Products,
*New Drug Applications,
*Patient Instructions...etc.
Currently working as a full time freelance pharmaceutical translator for various medical translation companies in Turkey and abroad. | This user has earned KudoZ points by helping other translators with PRO-level terms. Click point total(s) to see term translations provided.
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| Keywords: medical, nursing, denstistry, pharmacology, marketing authorization, drug products, pharmaceuticals, pharmachology, clinical review, non-clinical review, validation files, approval files, common technical documents, new drug applications, study reports, patient reports, medical devices, medical instruments, sop, ctd, icf
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