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General statistical considerations in the design of confirmatory clinical trials for antiviral drugs in uncomplicated influenza patients
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Ming-li HENG, Feng-yu SUN, Chen-bo ZHANG
Chinese Journal of Clinical Pharmacology | 2025, 41(18) : 2697 - 2700
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Chinese Journal of Clinical Pharmacology | 2025, 41(18): 2697-2700
Drug Evaluation and Administration
General statistical considerations in the design of confirmatory clinical trials for antiviral drugs in uncomplicated influenza patients
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Ming-li HENG, Feng-yu SUN, Chen-bo ZHANG
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2025-09-28 doi: 10.13699/j.cnki.1001-6821.2025.18.022
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The purpose of this article is to discuss the general statistical considerations of confirmatory clinical trial design of antiviral drugs for uncomplicated influenza patients, including estimands, sample size, bias control measures and statistical analysis methods, with reference to the Food and Drug Administration (FDA) biostatistics review report on baloxavir marboxil, the guidance of clinical trial technology for influenza treatment and prevention drugs, ICH E9R1 and statistical guidances issued by National Medical Products Administration (NMPA), in order to provide reference for clinical trial design of antiviral drugs in uncomplicated influenza patients.

antiviral drugs in uncomplicated influenza patients  /  clinical trial  /  statistical considerations
Ming-li HENG, Feng-yu SUN, Chen-bo ZHANG. General statistical considerations in the design of confirmatory clinical trials for antiviral drugs in uncomplicated influenza patients[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (18) : 2697 -2700 . DOI: 10.13699/j.cnki.1001-6821.2025.18.022
Year 2025 volume 41 Issue 18
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doi: 10.13699/j.cnki.1001-6821.2025.18.022
  • Receive Date:2025-06-13
  • Online Date:2026-08-05
  • Published:2025-09-28
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  • Received:2025-06-13
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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