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Hot information：
Top 10 Global CDMO Enterprises| The Meaning of IND, NDA and ANDA| Top 10 Global Clinical Research Organizations in 2021
Mar 31,2021
Principle of ELISA test
Enzyme-linked immunosorbent assay (ELISA) is an enzyme-labeled solid-phase immunoassay technology. The basic principle is to bind the antigen (or antibody) to the solid-phase carrier, convert the antigen (or antibody) and a certain enzyme into an enzyme-labeled antigen (or antibody). During the detection, the sample to be tested and the enzyme-labeled antigen (or antibody) are reactedRead more
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Principle of ELISA test
Mar 29,2021
Discussion on the Quality of Organs in the Safety Evaluation of Preclinical Drugs
The evaluation of organ quality in toxicity studies is an important part of the evaluation of drugs, compounds and medical devices. The American Society of Toxicology and Pathology (STP) has made corresponding guidelines and recommendations for organ weighing in general toxicity studies, and detailed the value of weighing data for major organs in special systemsRead more
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Discussion on the Quality of Organs in the Safety Evaluation of Preclinical Drugs
Mar 26,2021
What information will the IND review evaluate?
☆Background information for registration application The background information to be considered in an IND application mainly includes four parts: the structural source of the compound, the pharmacological classification, the current status of research/marketing of similar drugs at home and abroad, and the basic status of the application project. Among them, the structure source mainly analyzesRead more
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What information will the IND review evaluate?
Mar 26,2021
FDA's IND application strategy
An Investigational New Drug Application (IND) is the US FDA's approval for drugs that have not yet been approved for marketing and require clinical trials. In addition, the U.S. federal government prohibits intercontinental transportation and distribution of drugs that have not been approved by the FDA in the U.S. Therefore, for sponsors to transport drugsRead more
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FDA's IND application strategy
Mar 26,2021
Talking about IND application
The research and development of new drugs is a systematic project that encompasses the joint efforts of multiple disciplines, the collaboration of multiple departments, and the completion of the "dream”. However, due to the high-risk characteristics of the R&D process, even if everything is devoted to each link, it may not be able to bearRead more
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Talking about IND application
Mar 26,2021
Analysis of IND Application
In the past 150 years, the US FDA has grown from a department under the US Patent Office to one of the largest consumer protection agencies in the world today. Its main task is to ensure that medical supplies can reach consumers as much as possible to save them. At the same time, it isRead more
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Analysis of IND Application
Mar 26,2021
IND Application Strategy
An Investigational New Drug Application (IND) is the US FDA's approval for drugs that have not yet been approved for marketing and require clinical trials. In addition, the US federal government prohibits intercontinental transportation and distribution of drugs that have not been approved by the FDA in the United States. Therefore, for sponsors to transportRead more
More
IND Application Strategy
Mar 25,2021
LC-MS/MS (DIA) analysis of biopharmaceutical product HCP
Biomolecules obtained by eukaryotic or prokaryotic expression and gradual purification. The heterologous protein (Host Cell Protein, hereinafter referred to as HCP) in the product is a potential immune response to the human body and interferes with macromolecular products. Stability and other risks, research on HCP has become one of the hot spots in the qualityRead more
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LC-MS/MS (DIA) analysis of biopharmaceutical product HCP
Mar 25,2021
LC-MS/MS for Quantitative Analysis
After a century of development, LC-MS/MS has become more and more widely used in various fields such as medicine, food, environment, forensic medicine, and clinical medicine. Especially suitable for clinical testing, the scope of application far exceeds the scope of radioimmunoassay and chemical testing, which is unmatched by other methods. LC-MS/MS has the characteristics ofRead more
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LC-MS/MS for Quantitative Analysis
Mar 25,2021
Understand the Difference Between LC-MS and LC-MS/MS
LC-MS can obtain total ion chromatograms by collecting mass spectra. Because electrospray is a soft ionization source, there are usually few or no fragments. There are only quasi-molecular ions in the spectrum, so it can only provide molecular weight information of unknown compounds, not structural information. It is difficult to use for qualitative analysis, butRead more
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