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On February 18, the CDE official website issued an announcement stating that in order to guide the research on the mixing uniformity of chemical oral solid preparations and the uniformity of the medium-controlled dosage unit, and provide technical standards for reference, under the deployment of the State Drug Administration, the drug review The Center organized and issued the "Technical Guiding Principles for Research on Mixing Uniformity of Chemical Oral Solid Preparations and Controlled Dose Unit Uniformity (Trial)", which will be implemented from the date of issuance
.
This guiding principle is mainly drafted and formulated with reference to relevant international technical documents/guidances.
It aims to solve the problems of process control mixing uniformity and intermediate control dose unit uniformity that are concerned by the industry, and to provide a uniformity of mixing uniformity and intermediate control dose unit uniformity.
This research strategy is expected to provide a reference for the research on the uniformity of mixing and the uniformity of the medium-controlled dosage unit in the process of drug development and production
.
Attachment: Technical Guiding Principles for Research on Mixing Uniformity and Uniformity of Intermediate Controlled Dosage Units for Oral Chemical Oral Solid Preparations (Trial)
.
This guiding principle is mainly drafted and formulated with reference to relevant international technical documents/guidances.
It aims to solve the problems of process control mixing uniformity and intermediate control dose unit uniformity that are concerned by the industry, and to provide a uniformity of mixing uniformity and intermediate control dose unit uniformity.
This research strategy is expected to provide a reference for the research on the uniformity of mixing and the uniformity of the medium-controlled dosage unit in the process of drug development and production
.
Attachment: Technical Guiding Principles for Research on Mixing Uniformity and Uniformity of Intermediate Controlled Dosage Units for Oral Chemical Oral Solid Preparations (Trial)
