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Analysis of bioequivalence studies of omeprazole enteric-coated preparations in China
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Man LIU, Hui-chen LIU
Chinese Journal of New Drugs | 2023, 32(6) : 605 - 609
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Chinese Journal of New Drugs | 2023, 32(6): 605-609
Analysis of bioequivalence studies of omeprazole enteric-coated preparations in China
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Man LIU, Hui-chen LIU
Affiliations
  • Phase I Clinical Trial Ward, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing 100037, China
Published: 2023-03-30
Outline
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The bioequivalence studies of enteric-coated preparations are one of the difficulties in the generic drug consistency evaluation. Omeprazole is a representative drug of proton pump inhibitors (PPIs). This article summarizes and analyzes the bioequivalence studies of omeprazole enteric-coated preparations which have passed through the generic drug consistency evaluation. Some suggestions are put forward for the content, design and sample size of the bioequivalence studies, aiming to provide reference for the bioequivalence studies of omeprazole enteric-coated preparations in the future.

omeprazole enteric-coated preparations  /  generic drug consistency evaluation  /  bioequivalence study
Man LIU, Hui-chen LIU. Analysis of bioequivalence studies of omeprazole enteric-coated preparations in China[J]. Chinese Journal of New Drugs, 2023 , 32 (6) : 605 -609 .
Year 2023 volume 32 Issue 6
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Article Info
  • Online Date:2026-03-06
  • Published:2023-03-30
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History
  • Accepted:2022-06-13
Affiliations
    Phase I Clinical Trial Ward, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing 100037, 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
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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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