Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

2019 ◽  
Author(s):  
Keyword(s):  
Drug Evaluation ◽  
Biosimilar Product ◽  
Therapeutic Biologics

Drug evaluation programs of the AMA 1905-1966

JAMA ◽  
1966 ◽  
Vol 196 (6) ◽  
pp. 496-498 ◽  
Author(s):  
J. Bishop
Keyword(s):  
Drug Evaluation ◽  
Evaluation Programs

An Automated Clinical Information System

1964 ◽  
Vol 3 (02) ◽  
pp. 45-50 ◽  
Author(s):  
D. Yoder ◽  
R. Swearingen ◽  
E. Schenthal ◽  
W. Sweeney ◽  
J. Nettleton
Keyword(s):  
Natural Language ◽  
Clinical Information System ◽  
Drug Evaluation ◽  
Scientific Information ◽  
Clinical Information ◽  
Clinical Situation ◽  
Field Variable ◽  
Record System ◽  
New Members ◽  
Clinical Terminology

An automated clinical record system must have the following characteristics: as far as the physician is concerned it must operate in natural language on standard sized paper; it must be able to accept information from the physician at a time when he is oriented to clinical terminology and a clinical mode of thinking; it must have an output which is clinically useful for the care and management of a patient; each item of information must be addressable so that it may act as an index for scientific information retrieval; it must be capable of accepting quantative and natural language information.Clinical information constitutes a mathematical set, only a few members of which are applicable to any particular clinical situation, and to which new members are constantly being added. The members of this set are seldom mutually exclusive. An acceptable system which is capable of processing this type of information has been designed utilizing the concepts of self-encoding forms and variable-field, variable-length records. Applications of these principles will expedite hospital automation, the establishment of drug evaluation information systems, and of regional and nationwide medical record systems.

scholarly journals COVID-19 vaccines: progress and understanding on quality control and evaluation

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Qunying Mao ◽  
Miao Xu ◽  
Qian He ◽  
Changgui Li ◽  
Shufang Meng ◽  
...  
Keyword(s):  
Quality Control ◽  
Global Health ◽  
Research And Development ◽  
Drug Evaluation ◽  
Control Laboratory ◽  
Vaccine Candidates ◽  
Regulatory Authorities ◽  
Quality Control Laboratory ◽  
Leading Role ◽  
National Quality

AbstractThe outbreak of COVID-19 has posed a huge threat to global health and economy. Countermeasures have revolutionized norms for working, socializing, learning, and travel. Importantly, vaccines have been considered as most effective tools to combat with COVID-19. As of the beginning of 2021, >200 COVID-19 vaccine candidates, covering nearly all existing technologies and platforms, are being research and development (R&D) by multiple manufacturers worldwide. This has posed a huge obstacle to the quality control and evaluation of those candidate vaccines, especially in China, where five vaccine platforms are deployed in parallel. To accelerate the R&D progress of COVID-19 vaccines, the guidances on R&D of COVID-19 vaccine have been issued by National Regulatory Authorities or organizations worldwide. The Center for Drug Evaluation and national quality control laboratory in China have played a leading role in launching the research on quality control and evaluation in collaboration with relevant laboratories involved in the vaccine R&D, which greatly supported the progression of vaccines R&D, and accelerated the approval for emergency use and conditional marketing of currently vaccine candidates. In this paper, the progress and experience gained in quality control and evaluation of COVID-19 vaccines developed in China are summarized, which might provide references for the R&D of current and next generation of COVID-19 vaccines worldwide.

scholarly journals Microfluidics in cardiovascular disease research: state of the art and future outlook

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Qingming Ma ◽  
Haixia Ma ◽  
Fenglan Xu ◽  
Xinyu Wang ◽  
Wentao Sun
Keyword(s):  
Cardiovascular Disease ◽  
Cardiovascular Diseases ◽  
State Of The Art ◽  
Drug Evaluation ◽  
Diagnostic Methods ◽  
Comprehensive Understanding ◽  
Pathogenetic Mechanisms ◽  
Disease Research ◽  
Delivery Vehicles ◽  
Primary Strategy

AbstractDue to extremely severe morbidity and mortality worldwide, it is worth achieving a more in-depth and comprehensive understanding of cardiovascular diseases. Tremendous effort has been made to replicate the cardiovascular system and investigate the pathogenesis, diagnosis and treatment of cardiovascular diseases. Microfluidics can be used as a versatile primary strategy to achieve a holistic picture of cardiovascular disease. Here, a brief review of the application of microfluidics in comprehensive cardiovascular disease research is presented, with specific discussions of the characteristics of microfluidics for investigating cardiovascular diseases integrally, including the study of pathogenetic mechanisms, the development of accurate diagnostic methods and the establishment of therapeutic treatments. Investigations of critical pathogenetic mechanisms for typical cardiovascular diseases by microfluidic-based organ-on-a-chip are categorized and reviewed, followed by a detailed summary of microfluidic-based accurate diagnostic methods. Microfluidic-assisted cardiovascular drug evaluation and screening as well as the fabrication of novel delivery vehicles are also reviewed. Finally, the challenges with and outlook on further advancing the use of microfluidics technology in cardiovascular disease research are highlighted and discussed.

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