6. Qian C, Bo X-C, Hao J-Q,Wang Z, Li B. Chimeric antigen receptor engineered cells and their clinical application in infectious disease. Clin Transl Disc . 2022;2:e129. Clinical and Translational Discovery(CTD)是Wiley出...
基于毕业论文,她系统地科学地回顾、思考、与展望了自己科研方向,结合自己研究发现,撰写了这篇优秀综述(The relationship between cholesterol metabolism and mitochondrial function in chronic obstructive pulmonary diseases - Li - 2022 - Clinical and Translational Discovery - Wiley Online Library)。下面是李立杨博士...
5. Clinical Study Reports (clinical studies) The Common Technical Document is better understood with a CTD triangle which is presented AT THE HEADER The CTD is the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to...
Best Practice & Research Clinical RheumatologyMosca M, Tani C, Carli L, Bombardieri S (2012) Undifferentiated CTD: a wide spectrum of autoimmune diseases. Best Pract Res Clin Rheumatol 26(1):73–77Mosca M, Tani C, Carli L, Bombardieri S (2012) Undifferentiated CTD: a wide spectrum of ...
11、e testsmanufacturing process of pilot scale testsmanufacturing process of large scale testsMain variation Supporting informationSummarized the sample condition of representative batches (including but not limited to clinical research batch, pilot scale batch, on-site verification batch, process vali 12...
IPAF为近年来提出新型概念，为介于ITP与CTD-ILD之间的病，具有特征性的临床特点，但无法诊断CTD，有学者认为,可能为CTD早期阶段，加上CTD-ILD发病率以及死亡率逐年上升，早期发现IPAF变得尤为重要。目的：通过分析结缔组织病相关性间质性肺病CTD-ILD与IPAF的临床表现、影像学、病理学、自身抗体等特点及治疗特征，探讨...
manufacturing process of pilot scale tests manufacturing process of large scale tests Main variation Supporting information 2 Summarized the sample condition of representative batches (including but not limited to clinical research batch, pilot scale batch, on-site verification batch, process validation ...
Migration times or apparent mobilities can never be used for the identification of ionic species in capillary zone electrophoresis if an electroosmotic flow (EOF) is present, because the velocity of this flow varies considerably with the... JL Beckers,FM Everaerts,MT Ackermans - 《Journal of Chro...
Preparation of clinical drug development: trial design and phases, review and submission of CTAs and INDs, MAA and NDA, quality issues and audit findings in clinical trials and writing of SOPs
Module 5covers clinical study reports to support efficacy claims. The electronic form of this marketing authorisation document, known as an eCTD, contains the same information found in a regular CTD. The individual modules are saved as XML documents in a specific file structure. Supplementary informa...