s*****y
发帖数: 4595 | 1 最近在写一个test method. 被建议开始做个initial calibration curve,中间blank,
QC， blank, samples, blank, QC, blank, 最后再做一个bracketing calibration
curve.
如果是一般的anlytical method,一般不会需要最后这个bracketing calibration
curve. 对于bioanalytical quantitation,这个是不是很有必要呢？
有经验的同学帮忙讲解一下？ | w*********l
发帖数: 5144 | 2 it's not required in FDA guidance for industry. but some prefer to do so to
monitor any singnal drift due to matrix effect. LLOQ may change after a
long sequence. | s*****y
发帖数: 4595 | 3 thanks for the input, that is what i am interested.
for our "analytical" ppl, we generally do only one calibration curve in the
beginning and monitor any signal drift by applying QCs through the sequence.
but it looks like, due to the nature of bioanalysis, having a bracketing
calibration curve in the end is quite a common practice.:)
to
【在 w*********l 的大作中提到】
: it's not required in FDA guidance for industry. but some prefer to do so to
: monitor any singnal drift due to matrix effect. LLOQ may change after a
: long sequence.
| n*****g
发帖数: 4117 | 4 can anyone tell me if sleepy is sleeping | w*********l
发帖数: 5144 | 5 rite. analytical an bioanalytical are slightly different. for example,
bracketing QC, for analytical, just inject same solution, for bioanalytical,
you need prepare each QC separately, even though they are basically the
same.
the
sequence.
【在 s*****y 的大作中提到】
: thanks for the input, that is what i am interested.
: for our "analytical" ppl, we generally do only one calibration curve in the
: beginning and monitor any signal drift by applying QCs through the sequence.
: but it looks like, due to the nature of bioanalysis, having a bracketing
: calibration curve in the end is quite a common practice.:)
:
: to
| s*****y
发帖数: 4595 | 6 thanks, our group is previously strictly working on GMP analytical work, and
this will be our first GMP bioanalytical method development. I sure will
have a lot to ask and learn from more experienced classmates here. :)
bioanalytical,
【在 w*********l 的大作中提到】
: rite. analytical an bioanalytical are slightly different. for example,
: bracketing QC, for analytical, just inject same solution, for bioanalytical,
: you need prepare each QC separately, even though they are basically the
: same.
:
: the
: sequence.
| m****e
发帖数: 255 | 7 讨论一下：正确的做法是不是应该bracket curve points? 否则前后两个 curve不一样
，assay用哪个？ | s**********8
发帖数: 25265 | 8 average
【在 m****e 的大作中提到】
: 讨论一下：正确的做法是不是应该bracket curve points? 否则前后两个 curve不一样
: ，assay用哪个？
| s*******c
发帖数: 179 | 9 I think bracket curve is not required by FDA, but some companies prefer to
have a bracket curve to look at the variance in the batch. Another common
practice is to use only one curve, but put each calibrator randomly among
the batch samples, and the first and last one is a calibrator. | S***x
发帖数: 2012 | 10 有的公司是这样要求的，头儿打一次curve,尾也要打一次curve. 不过这样做的公司很少
,
【在 s*****y 的大作中提到】
: 最近在写一个test method. 被建议开始做个initial calibration curve,中间blank,
: QC， blank, samples, blank, QC, blank, 最后再做一个bracketing calibration
: curve.
: 如果是一般的anlytical method,一般不会需要最后这个bracketing calibration
: curve. 对于bioanalytical quantitation,这个是不是很有必要呢？
: 有经验的同学帮忙讲解一下？
| S***x
发帖数: 2012 | 11 对，而且最后一个样品最好是standard,且不能failed
【在 s*******c 的大作中提到】
: I think bracket curve is not required by FDA, but some companies prefer to
: have a bracket curve to look at the variance in the batch. Another common
: practice is to use only one curve, but put each calibrator randomly among
: the batch samples, and the first and last one is a calibrator.
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