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    廠家藥品長期性試驗室穩定性試驗研究方法


    廠家藥品長期性試驗室穩定性試驗研究方法

       一般來說,藥品長期性試驗室廠家的穩定性研究設計方法可以分為兩類。一類稱為完全研究設計方法(full study design),另一類叫做簡化設計方法(reduced study design)。前者是對所有樣品在每一個規定時間點對每一個設計因素之間的關系都進行測定。后者是對一部分樣品的規定時間點的測定。當有多種設計因素需要被測試時,前一種方法就顯示了優越性。在許多情況次啊,廠家藥品長期性試驗室http://www.dghuanyi.com/products_content-773122.html簡化設計方法是否可以用于穩定性研究取決于下列若干因素:

       1.當數據出現差異時,有統計方法可以調整;

       2.測試藥品的穩定性要有一定的可預見性;

       3.有輔助數據可供參考;

       4.影響穩定性研究的因素(如包裝、劑量等等)比較明確。

       當然,藥品長期性試驗室使用簡化設計方法的風險也是應當考慮的另一個方面。首先,這一方法的統計強度不夠,因而得到的有效期通常比較短。另外,所得到的這種短而有效也可能是在最不好的數據點上而獲得的。其次,由于所收集的數據比較少,因此,最后的結論可能建立在不完善的數據群上。最后,不可能獲得包括所有影響因素在內的有效期。

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