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

Changes of Toxicological Equivalence Criteria

Key points in the latest 2012 revision of EU Sanco 10597/2003 Technical Equivalence Tier II data requirement are as below: 1. For ≥0.1% – <1% new or increased impurities: Ames study; 2. For 2. ≥1% new or increased impurities, 3 in vitro genotoxicity studies, and consider: a) Acute oral; b) Sensitization; c) Developmental study; d)Read more

New drug toxicity testing service (European GLP/GCP standard)

The well-known European Institute of Toxicology and Experimental Medicine (Institut Toxikologie und Experimentelle Medizin, ITEM) is one of the most famous toxicology research institutions in Europe, and enjoys a world reputation especially in the research of respiratory toxicology. ITEM looks forward to cooperating with Chinese drug research and development institutions (pharmaceutical companies) in the safetyRead more

New drug toxicity testing service (European GLP/GCP standard)

The importance of toxicological data to clinical trial design

Toxicological research is an important part of the non-clinical safety evaluation process of drugs. The purpose is to clarify the toxic reaction, dose correlation, toxicity and drug exposure of target organs before developing new drugs for humans and during clinical research. The reversibility of toxic reactions. This information is helpful for estimating the safe startingRead more

The importance of toxicological data to clinical trial design

Discussion: Contents and procedures of "development and evaluation” of innovative drugs

In recent years, under the guidance of national policies, the development of domestic innovative drugs has been extremely hot. Many pharmaceutical companies have opened their own innovation departments, and whether it is to engage in projects on their own, or to buy projects in the BD department, and to develop innovative drugs, it seems thatRead more

Discussion: Contents and procedures of "development and evaluation” of innovative drugs

Differences in the requirements of Chinese pharmacology and toxicology data for registration application

CFDA basic requirements for non-clinical pharmacology/toxicology content Study on primary and secondary pharmacodynamics and mechanism of action ● First determine the registration classification. The newer the registration classification and the newer the target, the more research on drug efficacy is needed, and different animal models should be used to illustrate the clinical and mechanism feasibilityRead more

Differences in the requirements of Chinese pharmacology and toxicology data for registration application

Meaning of Toxicology Standards

Medicines are the crystallization of important weapons for mankind to protect itself against the outside world; in its research process, many disciplines and systems engineering are refined. There are many pharmacological accidents caused by drug safety issues in history, and they also gave birth to many evaluation systems. Today we are going to talk aboutRead more

Meaning of Toxicology Standards

Toxicology in new drug development

There have been surveys showing that in the preclinical stage of drug candidates, toxicity problems are the main reason for development failures, accounting for about 40% of all development failures. It can be seen that in the early stages of development, detecting potential toxicity problems as early as possible and determining their safety as muchRead more

Toxicology in new drug development

what is the process of Immunofluorescence?

Immunofluorescence technique (Immunofluorescence technique, IF), also known as fluorescent antibody technique, is one of the earliest developed labeling immunological techniques. In 1941, Coons and others successfully used fluorescein to label antibodies for the first time and established immunofluorescence technology. After decades of development, the technology has become quite mature.

what is the process of Immunofluorescence?

Misunderstanding of immunofluorescence analysis

Recently, many fans have successively asked questions about "immunofluorescence” in the background, basically asking questions about immunofluorescence analysis. Here comes the problem. "Should immunofluorescence be analyzed?” Regarding this topic, I would like to discuss it carefully in a question-and-answer manner. In this way, people who read this article will not feel confused. Question 1: WhatRead more

Misunderstanding of immunofluorescence analysis

Direct Immunofluorescence or Indirect Immunofluorescence Detection

Direct and indirect methods are not limited to immunofluorescence, they are also related to other technologies that rely on fluorescent dyes, enzymes or colored particles coupled to antibodies, such as flow cytometry, ELISA, and immunohistochemistry. But these two methods are different. As shown in the table below, both methods have their pros and cons: directRead more

Direct Immunofluorescence or Indirect Immunofluorescence Detection

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