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Top 10 Global Clinical Research Organizations in 2021| Medicilon Pharmacokinetic Services for First-in-Class Ubiquitination Inhibitor Development| ADC, precision and deep cultivation for targeted drug delivery
Sep 10,2021
The Consistency Evaluation of Generic Drugs Requires Attention to the Particle Size of API
In the development of pharmaceutical preparations, due to the different synthesis processes of API from different sources, there may be differences in their solubility, crystal form, particle size, and impurities, which may affect the consistency of the product. In the evaluation of the consistency of generic drugs, the particle size control of API should notRead more
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The Consistency Evaluation of Generic Drugs Requires Attention to the Particle Size of API
Sep 10,2021
In Vivo and in Vitro Studies of Formulation and Consistency Evaluation of Generic Drugs
In the consistency evaluation of generic drugs, it is very important to take effective measures to accurately evaluate the in vivo and in vitro relevance of drugs. Appropriate in vivo and in vitro correlation models can accurately predict the action characteristics of the drug in vivo, thereby guiding and optimizing the formulation design, establishing moreRead more
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Sep 09,2021
Construction and Supervision of GLP Laboratory
Good Laboratory Practice(GLP) is related to drug registration. It is a regulatory document that non-clinical trials used to evaluate drug safety need to comply with. Many new drugs entered the clinic after simple animal experiments showed that they had certain effects and were not very toxic. At the same time, the clinical trial was tooRead more
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Construction and Supervision of GLP Laboratory
Sep 09,2021
Gap in GLP Practice Between China and Foreign Countries
The Code of Quality Management for Non-clinical Research of Drugs, or GLP for short, is the basic principle that must be followed for pre-clinical research of drugs. It is also a fundamental measure to improve the quality of new drug research from the source and ensure the safety of drug use by the people. AfterRead more
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Gap in GLP Practice Between China and Foreign Countries
Sep 08,2021
Feeding and management of animals in GLP lab
GLP, non-clinical quality management practices for drugs, is the basic principle that drugs must follow for pre-clinical research. At present, the distance between my country's GLP organization, China GLP, and developed countries such as the United States, has gradually narrowed, and the organization that ranks first in China's GLP organization also affirms the strength ofRead more
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Feeding and management of animals in GLP lab
Sep 07,2021
Medicilon's antibody drug R&D technology platform assisted Bio-Thera Solutions, Ltd's two projects to get the clinical approvals
Recently, Bio-Thera Solutions, Ltd. (Bio-Thera)'s BAT6021 injection and BAT6005 injection of innovative drugs have been approved for clinical use, which means the new progress has been made in the field of tumor treatment. Recently, Bio-Thera Solutions, Ltd. (Bio-Thera)'s BAT6021 injection and BAT6005 injection of innovative drugs have been approved for clinical use, which means theRead more
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Sep 07,2021
Medicilon assists Chipscreen Biosciences' CS12192 to be approved by the FDA
On August 28, 2021, the FDA recently approved the CS12192, a new drug clinical trial application for the treatment of Graft Versus Host Disease (GVHD) independently developed by Chipscreen Biosciences (Chipscreen).  Previously, the drug has obtained clinical approval in China. It is worth mentioning that Shanghai Medicilon Inc. (Medicilon) provides comprehensive preclinical research including pharmacokineticsRead more
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Medicilon assists Chipscreen Biosciences' CS12192 to be approved by the FDA
Sep 07,2021
GLP requirements for animal lab environment and facilities
Animal experiment facilities refer to the sum of buildings, equipment, and operation management for the purpose of research, experimentation, teaching, biological products and pharmaceutical production, etc., for the breeding and experimentation of experimental animals. Its management is very important for applying for GLP certification. Companies that rank high in China's GLP organization will undoubtedly payRead more
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GLP requirements for animal lab environment and facilities
Sep 07,2021
Analysis of the role of GLP regulations and ideas
The pharmaceutical production quality assurance system-Pharmaceutical Non-clinical Research Quality Management Practices (GLP) is the key to improving the quality of pharmaceuticals. It is a common practice for non-clinical drug safety evaluation work in the world, and it is also the international toxicology data exchange and mutual recognition of information. The basics. The GLP laboratories ownedRead more
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Analysis of the role of GLP regulations and ideas
Sep 07,2021
Why should GLP regulations be implemented in new drug research?
GLP, Good Laboratory Practice, is a standard for safety evaluation experiments conducted on medicines, pesticides, food additives, cosmetics, etc., involving all aspects of laboratory work. For drug development, the implementation of GLP in pharmacology and toxicology research can guarantee the reliability, completeness and repeatability of experimental results. The top institutions in the ranking of ChineseRead more
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Why should GLP regulations be implemented in new drug research?