標題: Titlebook: Regulatory Aspects of Gene Therapy and Cell Therapy Products; A Global Perspective Maria Cristina Galli,Mercedes Serabian Book 20151st edit [打印本頁] 作者: 自由才謹慎 時間: 2025-3-21 18:36
書目名稱Regulatory Aspects of Gene Therapy and Cell Therapy Products影響因子(影響力)
書目名稱Regulatory Aspects of Gene Therapy and Cell Therapy Products影響因子(影響力)學科排名
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書目名稱Regulatory Aspects of Gene Therapy and Cell Therapy Products被引頻次
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書目名稱Regulatory Aspects of Gene Therapy and Cell Therapy Products讀者反饋
書目名稱Regulatory Aspects of Gene Therapy and Cell Therapy Products讀者反饋學科排名
作者: 安裝 時間: 2025-3-21 20:27
978-3-319-35729-4American Society of Gene and Cell Therapy 2015作者: BARK 時間: 2025-3-22 03:24 作者: myopia 時間: 2025-3-22 06:14
Advances in Experimental Medicine and Biologyhttp://image.papertrans.cn/r/image/825727.jpg作者: 不在灌木叢中 時間: 2025-3-22 10:04
https://doi.org/10.1007/978-3-319-18618-4Cell therapy; Cell therapy products; Gene therapy; Regulatory oversight; Regulatory policies作者: 下邊深陷 時間: 2025-3-22 16:25
Alexander M. Bailey Ph.D.,Judith Arcidiacono M.S.,Kimberly A. Benton Ph.D.,Zenobia Taraporewala Ph.D作者: hemophilia 時間: 2025-3-22 17:02
Marina O’Reilly Ph.D.,Robert Jambou Ph.D.,Eugene Rosenthal Ph.D.,Maureen Montgomery,Morad Hassani M.作者: 嫌惡 時間: 2025-3-22 23:11 作者: medium 時間: 2025-3-23 02:20 作者: 加入 時間: 2025-3-23 07:58 作者: 向外 時間: 2025-3-23 10:01 作者: Intellectual 時間: 2025-3-23 14:32 作者: 殺人 時間: 2025-3-23 18:15
Minjoung Choi,Euiri Han,Sunmi Lee,Taegyun Kim,Won Shin作者: 持久 時間: 2025-3-24 00:09 作者: 增強 時間: 2025-3-24 02:42 作者: Alcove 時間: 2025-3-24 10:23
The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and funds and the institution that developed the investigational materials sponsors or participates in these projects. Trials are registered with the NIH Office Biotechnology Activities (OBA) and there are ongoing reporting requirements. Each new trial is reviewed by the RAC, and those that are novel o作者: G-spot 時間: 2025-3-24 14:03
Regulatory Oversight of Cell and Gene Therapy Products in Canada,mited to providing proof of concept, and the first meaningful data relating to appropriate dosing, safety parameters, and validity of surrogate or true determinants of efficacy must come from carefully designed clinical trials in patients. Addressing these numerous challenges requires application of作者: 存在主義 時間: 2025-3-24 16:23
Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Cliniut complementary authorisation procedures. The first procedure is aimed at assessing the ethical aspect of the biomedical research, while the second has to review the safety and regulatory aspects. A third procedure has to be envisaged where in case the investigational product consists or contains a作者: HATCH 時間: 2025-3-24 20:35
Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany,ects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.作者: 使人煩燥 時間: 2025-3-24 23:56 作者: Gobble 時間: 2025-3-25 07:16
Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Sinded to be used for or administered to, human beings for the diagnosis, treatment, or prevention of human diseases or conditions. Gene therapy products are included under the current biological medicinal product definition.作者: Malaise 時間: 2025-3-25 09:10
Book 20151st editionf Gene and Cell Therapy .sub-series of the highly successful .Advances in Experimental Medicine and Biology .series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals..作者: ODIUM 時間: 2025-3-25 12:04 作者: Circumscribe 時間: 2025-3-25 18:07
sediment volume of 1.625 Mm. and a lower erosion rate of 1.98 mm/year/km.. The forest area increased 1.05% during this period. In the recent period, from 1991 to 2000, the annual sediment volume was 0.36553 Mm. and the erosion rate was 0.445 mm/year/km.. These low rates were associated with a 4.95%作者: CRAMP 時間: 2025-3-25 20:18
Choon Wee Goh B.Sc.,Srinivasan N. Kellathur Ph.D.,Lee Lee Ong Ph.D.,Xiaofeng Wu M.B.B.S., M.Sc., Ph. The biology, ecology, and management of major insects for which very little was known nearly two decades ago have now been studied. At the same time, collaboration among forest entom- ogists and other scientis978-1-4020-6507-1978-1-4020-6508-8作者: 桶去微染 時間: 2025-3-26 01:13
0065-2598 icine and Biology .series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals..978-3-319-35729-4978-3-319-18618-4Series ISSN 0065-2598 Series E-ISSN 2214-8019 作者: corpus-callosum 時間: 2025-3-26 08:17
United States Food and Drug Administration Regulation of Gene and Cell Therapies,t, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes, regulations, and guidance documents. Within this framework, there is considerable flexibility which is n作者: placebo 時間: 2025-3-26 11:03
The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and ynthetic nucleic acid molecules to humans, originates with the . (.). The ., which were first published in the Federal Register almost 40 years ago, have been amended numerous times to remain responsive to scientific progress and to clearly define the responsibilities of NIH, the Recombinant DNA Adv作者: 裝入膠囊 時間: 2025-3-26 16:43 作者: 脫水 時間: 2025-3-26 18:04
Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinih should be developed according to a well-structured development plan, to establish their quality, safety and efficacy profile and conclude, at the time of the marketing authorisation evaluation, on a positive risk/benefit balance for patients. An important part of this development plan is achieved 作者: Gum-Disease 時間: 2025-3-26 21:27 作者: Receive 時間: 2025-3-27 03:59 作者: 紋章 時間: 2025-3-27 07:11
Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland,efly described, as are Swiss-specific terminologies such as the term “transplant product,” which means products manufactured from cells, tissues, or even whole organs. Although some parts of this chapter may show a guideline character, they are not legally binding, but represent the current thinking作者: 教義 時間: 2025-3-27 10:12 作者: countenance 時間: 2025-3-27 15:02 作者: 吹氣 時間: 2025-3-27 20:23
Regulation of Cell and Gene Therapy Medicinal Products in Taiwan,more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulatio作者: 下邊深陷 時間: 2025-3-27 22:44
Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Siare working towards establishing a risk-based system in the regulatory framework. Similarly in Singapore, a risk-based tiered approach has been applied whereby clinical trials and product licence of high-risk cell- and tissue-based therapeutic products (substantially manipulated products, products i作者: obviate 時間: 2025-3-28 03:20 作者: 俗艷 時間: 2025-3-28 09:30
Regulatory Frameworks for Gene and Cell Therapies in Japan,accompanying guidelines for these two Acts are currently in preparation. It is expected that the new legislative frameworks will promote the timely development of new products and technologies, to bring safe and effective regenerative medicines to Japanese patients.作者: SPURN 時間: 2025-3-28 13:50 作者: mutineer 時間: 2025-3-28 15:07 作者: Manifest 時間: 2025-3-28 19:56 作者: 膠狀 時間: 2025-3-29 00:17 作者: reserve 時間: 2025-3-29 04:02 作者: Noisome 時間: 2025-3-29 10:40 作者: Adulterate 時間: 2025-3-29 12:10
Book 20151st editionrnational bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to lic作者: Jogging 時間: 2025-3-29 18:40
