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The analysis of unconventional research projects and common problems in the in vitro consistency evaluation of oral solid generic drugs
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Na ZHAO, Jing SHI*
Acta Pharmaceutica Sinica | 2021, 56(6) : 1739 - 1744
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Acta Pharmaceutica Sinica | 2021, 56(6): 1739-1744
New Drug Forum
The analysis of unconventional research projects and common problems in the in vitro consistency evaluation of oral solid generic drugs
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Na ZHAO, Jing SHI*
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2021-06-12 doi: 10.16438/j.0513-4870.2021-0123
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Based on the "requirements on the submitted documents for consistency evaluation of generic oral solid dosage forms of chemical drugs" and relevant guidance, this article summarized and formulated the decision tree of in vitro consistency evaluation of oral solid generic drugs, discussed the differences and common problems of in vitro evaluation research projects under different conditions, selective analyzed the technical requirements and concern problems of unconventional research projects, and proposed corresponding recommendations for concern problems, in order to provide more references for the follow-up study on consistency evaluation of oral solid generic drugs.

oral solid generic drug  /  in vitro consistency evaluation  /  unconventional research project  /  similarity evaluation of dissolution curve  /  bioequivalence waiver
Na ZHAO, Jing SHI. The analysis of unconventional research projects and common problems in the in vitro consistency evaluation of oral solid generic drugs[J]. Acta Pharmaceutica Sinica, 2021 , 56 (6) : 1739 -1744 . DOI: 10.16438/j.0513-4870.2021-0123
Year 2021 volume 56 Issue 6
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doi: 10.16438/j.0513-4870.2021-0123
  • Receive Date:2021-01-22
  • Online Date:2025-12-18
  • Published:2021-06-12
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  • Received:2021-01-22
  • Revised:2021-02-22
Affiliations
    Center 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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