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Preliminary discussion about good manufacturing practice for investigational medicinal products
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Dan XU, Yuan WANG, Yi-min ZHANG, De LU, Yi CAO
Chinese Journal of New Drugs | 2021, 30(18) : 1649 - 1654
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Chinese Journal of New Drugs | 2021, 30(18): 1649-1654
Preliminary discussion about good manufacturing practice for investigational medicinal products
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Dan XU, Yuan WANG, Yi-min ZHANG, De LU, Yi CAO
Affiliations
  • Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China
Published: 2021-09-30
Outline
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Taking the specific guiding principles of foreign regulations as reference, combined with the domestic situations, this paper analyzed the problems of good manufacturing practice for investigational medicinal products and give practical suggestions on the quality of investigational medicinal products, in addition to providing a reference for new drug researchers, this paper also aimed to promote the quality management level of drugs for clinical trials, protect the rights of clinical patients, and ensure the quality of clinical trials.

investigational medicinal products  /  good manufacturing practice for drug  /  production and quality management
许丹, 王元, 张毅敏, 陆德, 曹轶. 临床试验用药品生产质量管理的初步探讨. 中国新药杂志, 2021 , 30 (18) : 1649 -1654 .
Dan XU, Yuan WANG, Yi-min ZHANG, De LU, Yi CAO. Preliminary discussion about good manufacturing practice for investigational medicinal products[J]. Chinese Journal of New Drugs, 2021 , 30 (18) : 1649 -1654 .
Year 2021 volume 30 Issue 18
26
3
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  • Online Date:2026-10-30
  • Published:2021-09-30
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  • Accepted:2021-04-10
Affiliations
    Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
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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