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Top 10 Global CDMO Enterprises| The Meaning of IND, NDA and ANDA| Top 10 Global Clinical Research Organizations in 2021

Drug Development Preclinical Stage Process

Whether it is new chemical entities (NCEs) representing small molecule compound drugs or new molecular entities (NMEs) or new biological entities (NBEs) representing biomacromolecule drugs, the basic criteria for evaluating drugs are safe, effective, and controllable. The research and development and production of drugs not only involve a series of internal issues such as complexRead more

Drug Development Preclinical Stage Process

Discovery and development of pre-clinical vitamin drugs (chemical drugs)

It is an extremely long and costly process. According to statistics, the average cost of new drug research and development is 2.6 billion U.S. dollars, which takes 10 years, but its capital return to successful people is also extremely rich. How to improve R&D efficiency and reduce the probability of R&D failure is a difficultRead more

Discovery and development of pre-clinical vitamin drugs (chemical drugs)

Preclinical CRO-The Safety Evaluation is the Main Sector

The safety evaluation is the main sector, and the certification qualification and the area of the laboratory are hard indicators Pre-clinical research services include safety evaluation research, pharmacokinetics, pharmacology and toxicology, animal models, etc. This stage is mainly to conduct laboratory research and live animal research on lead compounds under laboratory conditions to observe theirRead more

Preclinical CRO-The Safety Evaluation is the Main Sector

Application of Toxicokinetics in Different Toxicity Tests

The content of toxicokinetic studies in different toxicity tests, such as the frequency of exposure monitoring and characterization, can be increased or decreased according to research needs. The toxicokinetic studies of different toxicity tests are considered as follows: (1) Single-dose Toxicity Test The toxicokinetic results of a single-dose toxicity test are helpful for evaluating andRead more

Application of Toxicokinetics in Different Toxicity Tests

Technical Guidelines for Non-clinical Research of Radioactive In vivo Diagnostic Drugs

In order to promote and standardize the research and development of radioactive in vivo diagnostic drugs in my country, on February 24, under the deployment of the National Medical Products Administration, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for Non-clinical Research of Radioactive In vivo Diagnostic Drugs”, which was approvedRead more

The content of "pharmacology-toxicology" that needs to be studied in the Phase I clinical application of innovative drugs!

Toxicology, the safety pharmacology test, single-dose toxicity test, repeated-dose toxicity test, genotoxicity test, reproductive toxicity test, carcinogenicity test and other toxicity tests must be listed separately; if some studies have not been carried out or are not needed To proceed, the reasons and basis need to be explained.

The content of "pharmacology-toxicology" that needs to be studied in the Phase I clinical application of innovative drugs!

Toxicokinetics of Traditional Chinese Medicine Compound Preparations Containing Toxic Medicinal Materials

(1. Center for Drug Evaluation of the State Food and Drug Administration, Beijing 100038; 2. Laboratory of Pharmacology and Toxicology, Shanghai Family Planning Research Institute, China Fertility Regulation Drug Toxicology Testing Center, Shanghai 200032; 3. National Population and Planning Key Laboratory of Family Planning Medicines of the Fertility Committee, Shanghai 200032; 4. Institute of ReproductionRead more

Toxicokinetics of Traditional Chinese Medicine Compound Preparations Containing Toxic Medicinal Materials

Status and Prospects in Drug Toxicokinetics

As a cross-discipline of pharmacokinetics and toxicology, toxicokinetics has now become an important content of non-clinical drug research and a bridge and tool for advancing preclinical research to clinical research. This article reviews the basic content of domestic toxicokinetic research at this stage, focusing on the guiding principles of toxicokinetic research, precautions in various aspectsRead more

Status and Prospects in Drug Toxicokinetics

Non-clinical Drug Toxicokinetics Research

General principles of non-clinical toxicology research Toxicokinetics (TK) is a cross-discipline that combines pharmacokinetics (PK) and toxicology. It has now become an important part of drug development and non-clinical research. Toxicokinetics is the principle and method of applying pharmacokinetics. Quantitatively study the process and characteristics of drug absorption, distribution, metabolism, and excretion in animalsRead more

Non-clinical Drug Toxicokinetics Research

Nasal spray can prevent the spread of COVID-19

Recently, researchers have been studying how to prevent the new coronavirus from entering host cells. The antiviral lipopeptide is cheap to produce, has a long shelf life, and does not require refrigeration. These features make it stand out from other antiviral methods under development, including many monoclonal antibodies. The new nasal lipopeptide may be anRead more

Nasal spray can prevent the spread of COVID-19

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