PDF
Full
Outline
Focusing on the specialty of locally applied locally acting drugs, we discuss and explain the special considerations in its design and evaluation of clinical trials.
The technical guidelines on the research and development of locally applied locally acting drugs issued by domestic and foreign regulatory agencies and related literature were extensively investigated. The relevant drug research and development situation and review practice were combed. Combined with case analysis and expert discussion opinions, the technical standards for clinical research and development of local drugs under different registration types were discussed.
The sponsor should formulate the corresponding research and development strategy based on the clinical medication needs and developmental background. For the innovative drugs, in addition to following the general consideration of clinical trials of innovative drugs, specific studies should also be carried out at the same time considering the characteristics of drug dosage forms, the routes of administration, and application sites, etc. Meanwhile, due to the technical and ethical difficulties of sampling in local pharmacokinetics and pharmacodynamics research, pharmaceutical quality research and comprehensive non-clinical research are particularly important. Some necessary exploratory and confirmatory clinical trials should be carried out combining the clinical data of the original active ingredient to prove the clinical advantages in safety and effectiveness etc. of the improved drug. For generic drugs that is locally administered and locally acting, beside pharmacy and non-clinical comparative studies with the original reference preparations, the sponsors may also need to carry out necessary human pharmacokinetics, pharmacodynamics, and even clinical equivalence trials to prove the consistency of quality and efficacy of generic drugs and reference preparations.
PDF
34
11
| 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 |
关闭全屏
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62199257
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
