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Pharmeceutical research and development of generic temozolomide capsules
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Xin-zhu NA, Yan HE, Jun-lin ZHANG, Xiao-fei SI
Chinese Journal of Clinical Pharmacology | 2025, 41(3) : 442 - 444
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Chinese Journal of Clinical Pharmacology | 2025, 41(3): 442-444
Drug Evaluation and Administration
Pharmeceutical research and development of generic temozolomide capsules
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Xin-zhu NA, Yan HE, Jun-lin ZHANG, Xiao-fei SI
Affiliations
  • Centre for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2025-02-17 doi: 10.13699/j.cnki.1001-6821.2025.03.029
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Temozolomide capsule is a first-line chemotherapeutic agent for the treatment of glioblastoma and anaplastic astrocytoma. Combined with radiotherapy, it can significantly improve the survival rate of patients, which is of high clinical value. Based on the public information on the websites of National Medical Products Administration, Food and Drug Administration, European Medicines Angecy and Pharmaceuticals and Medical Devices Angecy, the contents of Chineses Pharmacopoeia, United States Pharmacopeia, British Pharmacopeia, and the requirements of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and domestic chemical generic drugs related guidelines, this paper proposed the pharmaceutical research and development concerns of this product, so as to promote the marketing of generic drugs.

temozolomide  /  generic drug  /  pharmaceutical research  /  waiver of in vivo bioequivalence study
Xin-zhu NA, Yan HE, Jun-lin ZHANG, Xiao-fei SI. Pharmeceutical research and development of generic temozolomide capsules[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (3) : 442 -444 . DOI: 10.13699/j.cnki.1001-6821.2025.03.029
Year 2025 volume 41 Issue 3
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doi: 10.13699/j.cnki.1001-6821.2025.03.029
  • Receive Date:2024-08-15
  • Online Date:2026-08-04
  • Published:2025-02-17
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  • Received:2024-08-15
Affiliations
    Centre for Drug Evaluation, National Medical Products Administration, Beijing 100022, 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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