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CDE: Publicly solicit opinions on the guiding principles of 17 varieties

 Last Update: 2021-07-28
 Source: Internet
 Author: User

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Transfer from: CDE Editor: Dandelion-Green Tea

On April 12-13, CDE issued 6 notices to solicit opinions on guiding principles

This consultation involves 16 varieties of 17 guiding principles as the technical guiding principles for bioequivalence research:

Technical Guidelines for Clinical Trials of Modified New Drugs for Children's Chemicals (Draft for Solicitation of Comments)

Technical guidelines for research on bioequivalence of ezetimibe tablets (draft for comments)

Guiding Principles for Research on Bioequivalence of Clopidogrel Bisulfate Tablets (Draft for Comment)

Guiding Principles of Simvastatin Tablets Bioequivalence Research (Draft for Solicitation of Comments)

Guiding Principles for Research on Bioequivalence of Clozapine Tablets (Draft for Comment)

Guiding Principles for Research on the Bioequivalence of Quetiapine Fumarate Tablets (Draft for Comment)

Technical guidelines for research on bioequivalence of Ebastine tablets (draft for comments)

Guiding Principles for Research on Bioequivalence of Propofol Medium and Long-chain Fat Emulsion Injection (Draft for Comment)

Guiding Principles for Research on Bioequivalence of Benazepril Hydrochloride Tablets (Draft for Comment)

Technical guidelines for the bioequivalence study of erlotinib hydrochloride tablets (draft for comments)

Guiding Principles for Research on the Bioequivalence of Sorafenib Mesylate Tablets (Draft for Solicitation of Comments)

Guiding Principles for Research on Bioequivalence of Afatinib Maleate Tablets (Draft for Comment)

Technical guidelines for the study of methotrexate tablets bioequivalence (draft for comments)

Guiding Principles for Research on Bioequivalence of Lercanidipine Hydrochloride Tablets (Draft for Comment)

Guiding Principles for Research on Bioequivalence of Potassium Chloride Sustained-Release Tablets (Draft for Solicitation of Comments)

Guiding Principles for Research on Bioequivalence of Ursodeoxycholic Acid Capsules (Draft for Comment)

Guiding Principles for Research on Bioequivalence of Sildenafil Citrate Orally Disintegrating Tablets (Draft for Comment)

Download guidelines:

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