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CDE issued four announcements, including "Technical Guidelines for Bioequivalence Research of Amphotericin B Liposomes for Injection"

 Last Update: 2022-12-30
 Source: Internet
 Author: User

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The Drug Review Center of the State Food and Drug Administration issued the "Technical Guidelines for Bioequivalence Research of Amphotericin B Liposomes for Injection", "Technical Guidelines for Bioequivalence Research of Tadalafil Tablets", "Technical Guidelines for Bioequivalence Research of Loratadine Tablets", and "Technical Guidelines for Bioequivalence Research of Tenofovir Propofovir Fumarate Tablets"

Release date: 20221125

In order to continuously enrich and improve the guiding principles of generic drugs, continue to promote consistency evaluation, and further guide the implementation and evaluation of bioequivalence research on liposomal amphotericin B for injection, the Center for Drug Review organized the drafting of the Technical Guidelines for Bioequivalence Research of Amphotericin B Liposomes for Injection (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: 1 Technical guidelines for the study of bioequivalence of amphotericin B liposomes for injection

2.
Technical guidelines for bioequivalence studies of tadalafil tablets

3.
Technical guidelines for the study of bioequivalence of loratadine tablets

4.
Technical guidelines for the study of bioequivalence of tenofovir tablets propofol fumarate

Drug Review Center, State Food and Drug Administration

November 21, 2022

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