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CDE issued a notice on the "Technical Guidelines for Pharmaceutical Research of Ethanol Dose Pouring Test for Oral Controlled Release Preparations of Chemical Generic Drugs"

 Last Update: 2022-11-26
 Source: Internet
 Author: User

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In order to standardize and guide the pharmaceutical research and development of oral modulated release preparations of chemical generic drugs, under the deployment of the State Medical Products Administration, the Center for Drug Review organized and formulated the "Technical Guidelines for Pharmaceutical Research of Ethanol Dose Pouring Test of Oral Modulated Release Preparations of Chemical Generic Drugs" (see annex).

In accordance with the requirements of the Notice of the General Department of the State Food and Drug Administration on the Procedures for Issuing Technical Guidelines for Drugs (Drug Administration [2020] No.
9), after the review and consent of the State Medical Products Administration, it is hereby issued and will come into force
on the date of promulgation.

Notice is hereby given
.

Annex: Technical guidelines for pharmaceutical research of chemical generic oral modulated release preparations ethanol dose pouring test

Drug Review Center, State Food and Drug Administration

November 7, 2022

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1	Technical Guidelines for Pharmaceutical Research of Ethanol Dose Dumping Test for Oral Controlled Release Preparations of Chemical Generic Drugs. . pdf

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