Technical Guidelines for Clinical Trials of Drugs for Chronic Hepatitis D Virus Infection, effective from the date of publication
Time:2024-06-26
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In order to guide the scientific research and development and evaluation of drugs for the treatment of chronic hepatitis D virus infection and to provide technical standards for reference, CDE organised and formulated the Technical Guidelines for Clinical Trials of Drugs for the Treatment of Chronic Hepatitis D Virus Infection, which was released by CDE on June 21 and came into effect on the date of release.
This guideline is mainly applicable to the clinical development of new drugs for the treatment of chronic HDV infection, and does not apply to adjuvant therapy and prophylactic drugs.
The content includes: overview, early clinical trials, confirmatory clinical trials, safety evaluation, clinical virology considerations and six appendices.
The content includes: overview, early clinical trials, confirmatory clinical trials, safety evaluation, clinical virology considerations and six appendices.
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