Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP)

Matthias Zscharnack; Christoph Krause; Gabriela Aust; Christian Thümmler; Frank Peinemann; Thomas Keller; Jeske J Smink; Heidrun Holland; Jeremy S Somerson; Jens Knauer; Ronny M Schulz; J?rg Lehmann

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Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP)

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

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来源
《Journal of Translational Medicine》 |2015年第1期|共页
作者
Matthias Zscharnack; Christoph Krause; Gabriela Aust; Christian Thümmler; Frank Peinemann; Thomas Keller; Jeske J Smink; Heidrun Holland; Jeremy S Somerson; Jens Knauer; Ronny M Schulz; J?rg Lehmann;
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中图分类心脏、血管（循环系）疾病;
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专利

1. Toward a European harmonisation of the requirements for the first clinical use of Advanced Therapy Medicinal Products (ATMPs): Preclinical requirements for cell based medicinal products [J] . MigliaccioG., CarellaC. Pharmaceuticals policy and law. . 2010,第1a2期

机译：在欧洲范围内，先进疗法药物（ATMP）首次临床使用的要求统一：基于细胞的药物的临床前要求
2. A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs) [J] . David R. Jones, James W. McBlane, Graham McNaughton, British journal of clinical pharmacology . 2013,第2期

机译：特别强调晚期治疗药品（ATMPS）的生物产品临床试验的监管观点
3. Interest of immunohistochemistry in the evaluation of tumorigenic potential of advanced therapy medicinal products [J] . Weidmann Katharina, Leoni Anne-Laure, Weber Klaus Toxicology Letters: An International Journal Providing a Forum for Original and Pertinent Contributions in Toxicology Research . 2014,第Null期

机译：免疫组化对评估晚期药物的致瘤潜力的兴趣
4. Evaluation of Dietetic Product Innovations: The Relative Role of Preclinical and Clinical Studies [C] . Maria Makrides, Robert A. Gibson Nestlé Nutrition Workshop . 2010

机译：饮食创新评价：临床前和临床研究的相对作用
5. Evaluation of the logistics methods for import and marketing of products in the Colon Free Zone: A case study of "Bristol Laboratories International S.A.". [D] . Ospina Balcazar, Manlio. 2000

机译：在科隆自由贸易区评估产品进口和销售的物流方法：以“ Bristol Laboratories International S.A.”为例。
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. 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：临床前良好实验室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

Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP)

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