Safety analysis of proposed pegfilgrastim biosimilar in Phase I and Phase III studies
نویسندگان
چکیده
منابع مشابه
synthesis of platinum nanostructures in two phase system
چکیده پلاتین، فلزی نجیب، پایدار و گران قیمت با خاصیت کاتالیزوری زیاد است که کاربرد های صنعتی فراوانی دارد. کمپلکس های پلاتین(ii) به عنوان دارو های ضد سرطان شناخته شدند و در شیمی درمانی بیماران سرطانی کاربرد دارند. خاصیت کاتالیزوری و عملکرد گزینشی پلاتین مستقیماً به اندازه و- شکل ماده ی پلاتینی بستگی دارد. بعضی از نانو ذرات فلزی در سطح مشترک مایع- مایع سنتز شده اند، اما نانو ساختار های پلاتین ب...
EQUILI - msatrIA PHASE I PHASE 11 PHASE III DIET
A B S T R A C T Precise, direct measurement of bone calcium release (vo) has been accomplished using a continuous tracer administration (CTA) technique. Dietary calcium (96.97% 4OCa) is replaced by 4OCa (99.991% 40Ca) and blood levels of the naturally occuring isotope 48Ca are monitored by neutron activation analysis as a function of time. 48Ca abundance falls as this isotope is excreted and on...
متن کاملPooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer
Background Following the functional and physicochemical characterization of a proposed biosimilar, comparative clinical studies help to confirm biosimilarity by demonstrating similar safety and efficacy to the reference product in a sensitive patient population. Patients and methods LA-EP2006 is a proposed biosimilar that has been developed for pegfilgrastim, a long-acting form of granulocyte...
متن کاملRandomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer
AIM This randomized, double-blind trial compared proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer (PROTECT-1). PATIENTS & METHODS Women (≥18 years) were randomized to receive LA-EP2006 (n = 159) or reference (n = 157) pegfilgrastim (Neulasta(®), Amgen) for ≤6 cycles of (neo)-adjuvant TAC chemotherapy. Primary end point was duration o...
متن کاملUsing phase II data for the analysis of phase III studies: An application in rare diseases
BACKGROUND Clinical research and drug development in orphan diseases are challenging, since large-scale randomized studies are difficult to conduct. Formally synthesizing the evidence is therefore of great value, yet this is rarely done in the drug-approval process. Phase III designs that make better use of phase II data can facilitate drug development in orphan diseases. METHODS A Bayesian m...
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ژورنال
عنوان ژورنال: Future Oncology
سال: 2019
ISSN: 1479-6694,1744-8301
DOI: 10.2217/fon-2018-0878