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Safety, Dosing, and Pharmaceutical Quality for Studies that Evaluate Medicinal Products (including Biological Products) in Neonates

机译：评估新生儿药品（包括生物产品）的研究的安全性，剂量和药物质量

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status: published

机译：状态：已发布

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作者
Ward, Robert; Benjamin, Danny; Barrett, J; Allegaert, Karel; Portman, Ron; Davis, M; Turner, Mark;
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年度 2017
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正文语种 en
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1. Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates [J] . Robert M. Ward Pediatric Research . 2017,第5期

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2. A Prospective, Randomized, Multiple-Dose, Multi-Center, Comparative Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity of a biosimilar Bevacizumab (Test product, Hetero) and Reference Medicinal Product (Bevacizumab, Roche) in Patients of Meta [J] . Suresh Advani, Ghanashyam Biswas, Shubhadeep Sinha, Journal of the Association of Physicians of India . 2018,第6期

机译：前瞻性，随机，多剂量，多中心，比较临床研究，以评估生物纤维生病（试验产品，杂种）和参考药品（Bevacizumab，Roche）的疗效，安全性，免疫原性在Meta患者中
3. A randomized, multiple-dose, multicenter, comparative parallel study to evaluate the safety and efficacy of intravenous infusion of rituximab (Hetero) and reference medicinal product (Rituximab, Roche) in Indian patients of non-hodgkin's lymphoma (HERILY) [J] . Suresh Advani, Ghanashyam Biswas, Shubhadeep Sinha, Indian Journal of Medical and Paediatric Oncology . 2018,第3期

机译：一项随机，多剂量，多中心，比较平行研究，以评估印度非霍奇金淋巴瘤（HERILY）患者静脉注射利妥昔单抗（Hetero）和参考药物（Rituximab，Roche）的安全性和有效性
4. Evaluation of the pharmaceutical quality and therapentic efficacy and safety of plantderived products by th german health authorities [C] . D.Loew Proceedings of '97 international seminar on ginkgo . 1997

机译：德国卫生部门对植物衍生产品的药物质量，治疗功效和安全性的评估
5. Evaluating the Feasibility of Producing Shelf-Stable Low-Acid Vegetables Through Pressure-Ohmic-Thermal Sterilization: Studies on Product Quality and Microbiological Safety. [D] . Park, Sung Hee. 2012

机译：通过压力-热-热灭菌来评估生产货架稳定的低酸蔬菜的可行性：产品质量和微生物安全性研究。
6. Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP) [O] . Matthias Zscharnack, Christoph Krause, Gabriela Aust, 2015

机译：临床前符合实验室良好操作规范的安全性研究以评估软骨高级治疗药物（ATMP）的生物分布和致瘤性
7. Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates [O] . Ward, RM, Benjamin, D, Barrett, JS, 2017

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8. FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products [R] . 1996

机译：FDa关于证明人类生物制品可比性的指南，包括治疗性生物技术衍生产品

Safety, Dosing, and Pharmaceutical Quality for Studies that Evaluate Medicinal Products (including Biological Products) in Neonates

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