Full
Outline
To review the progress on the study of drug accelerated stability models and search for a more efficient, lower-cost and more reliable model.
The study of drug stability is an indispensable step in the process of drug development. The advantages and disadvantages of the currently used accelerated stability models (ASMs), including classical Arrhenius' model, Waterman's model and Clancy's models, are compared from the aspects of factors for consideration, extensiveness of suitable application for drug substances, length of experimental period and accuracy of prediction.
There is only the effect of temperature which is considered in the classical Arrhenius' model, the experimental period is 3~6 months and even more and the range of application is narrow in this model that only less than 50% of drug substances could be used to predict the stability correctly. The effects of temperature and humidity on stability are taken into account in the Waterman's model and Clancy's models. The experimental period needs only 2~3 weeks, in which nearly 71% of the stability of the temperature and humidity influencing factors could be interpreted by Waterman's model, while almost all of them could be interpreted by Clancy's model, and the accuracy of prediction is higher than that of Waterman's model.
Clancy's model is more efficient, lower-cost and more reliable model than the current model; but the Waterman model is more widely used than the Clancy model.
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| 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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