ABSTRACT
OBJECTIVE: The manufacturing site of drugs is a combination of a series of production factors to meet the requirements of drugs production, which is not only the material basis of drugs production, but also the evaluation basis for the review when applying for registration. The purpose of this paper is to preliminarily discuss the definition and extension of production lines for chemical drugs in China, and provide some references for standardizing new drug application. METHODS: The historical requirements for manufacturing site information in application materials of chemical drugs in China were briefly introduced, with daily pharmaceutical evaluation works and specific cases study. RESULTS: AND CONCLUSION: It should make clear the definition and extension of production lines in the application materials, strengthen the effective communication between different regulatory authorities, update the relevant information in time, and should pay continuing attention to the revision progress of the laws and regulations requirements on the production line in China.
ABSTRACT
Background: Drug assessment is an important step to determine the effectiveness and safety of each compound. Any candidate substances are repeatedly tested to examine the activity and working mechanism. Drugs produce various effects through interaction with ionotropic receptors. Electrophysiological methods are used to detect such effects by monitoring the drug-ionotropic receptor interaction. Researchers are now focusing to develop simple and quick methods for drug assessment. Objective: This mini-review presents current drug assessment using electrophysiological methods, and clarifies various problems involved in the assessment.