各位先進好，很抱歉打擾了，
想請教大家：假使我想要測試一個新藥物，在細胞層級的實驗上，
以MTT assay為例，在treatment後48~72 hr再加入MTT reagent，
這樣的實驗設計(處理時間)是否有一定標準規範約束？
因為就學術領域來說，很多篇論文都有各自不同的處理條件，
想知道是否有類似ISO-10993的條例，並且是「藥物」適用的呢？
舉例來說：(ISO-10993-12-2007)
10.3
10.3.1
Extraction conditions are based on common practice and are
justified on the basis of providing a standardized approach that is,
in many ways, an appropriate exaggeration of product use. Extraction shall
be conducted under one of the following conditions (see also C.5):
a) (37 ± 1) °C for (72 ± 2) h;
b) (50 ± 2) °C for (72 ± 2) h;
c) (70 ± 2) °C for (24 ± 2) h;
d) (121 ± 2) °C for (1 ± 0,1) h.
NOTE Extraction at (37 ± 1) °C for (24 ± 2) h in tissue culture
media might be acceptable for cytotoxicity testing. See ISO 10993-5.
可是這個規範是適用於醫療器材生物相容性的，
而我另外也從FDA找了Guidance for Industry系列的文件，
像是Bioanalytical Method Validation, Analytical Procedures and
Methods Validation...等等
但裡面的敘述都很概略地帶過，而我想要找的是更精確地"可接受範圍"，
請問我該往哪個方向去找呢？先謝謝大家了。
--
想請教大家：假使我想要測試一個新藥物，在細胞層級的實驗上，
以MTT assay為例，在treatment後48~72 hr再加入MTT reagent，
這樣的實驗設計(處理時間)是否有一定標準規範約束？
因為就學術領域來說，很多篇論文都有各自不同的處理條件，
想知道是否有類似ISO-10993的條例，並且是「藥物」適用的呢？
舉例來說：(ISO-10993-12-2007)
10.3
10.3.1
Extraction conditions are based on common practice and are
justified on the basis of providing a standardized approach that is,
in many ways, an appropriate exaggeration of product use. Extraction shall
be conducted under one of the following conditions (see also C.5):
a) (37 ± 1) °C for (72 ± 2) h;
b) (50 ± 2) °C for (72 ± 2) h;
c) (70 ± 2) °C for (24 ± 2) h;
d) (121 ± 2) °C for (1 ± 0,1) h.
NOTE Extraction at (37 ± 1) °C for (24 ± 2) h in tissue culture
media might be acceptable for cytotoxicity testing. See ISO 10993-5.
可是這個規範是適用於醫療器材生物相容性的，
而我另外也從FDA找了Guidance for Industry系列的文件，
像是Bioanalytical Method Validation, Analytical Procedures and
Methods Validation...等等
但裡面的敘述都很概略地帶過，而我想要找的是更精確地"可接受範圍"，
請問我該往哪個方向去找呢？先謝謝大家了。
--
All Comments