请教一个做GMP bioanalysis的问题 - 未名空间MITBBS历史存档

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请教一个做GMP bioanalysis的问题

请教一个做GMP bioanalysis的问题# Chemistry - 化学

f*s2009-09-16 07:09

1 楼

4岁儿子圣诞节期间将跟妈妈来美国看望我。他现在的护照还是当年在美国出生时候办
的，5年有效，明
年就要过期了。这次他们母子在纽约待两周。
请教两个问题：
（1）如果不去邮局，在纽约有没有什么地方可以办美国护照？我听说申请办护照时候
，旧护照马上就过
期了，是这样吗？如果这样就很麻烦了，因为儿子还要用旧护照回国呢，除非有加急办
理美国护照。
我听说纽约downtown有个地方可以办理加急美国护照（当天或隔日取），是这样吗？有
知道具体位置和
联系电话吗？
（2）如果去中国驻纽约大使馆办理儿子回国旅行证，可以预约，然后当天取吗？
谢谢！

u*n2009-09-16 07:09

2 楼

我看了一下W2，确实是2010年没有扣SS and Med Tax。不过2011年的paycheck上面看到
扣了。现在还需要做啥吗？

s*02009-09-16 07:09

3 楼

单位里活越来越少，已经有1/5 的人闲下来了，2，3个月后会有更多的人闲下来。
我已经闲了很久，和我关系好的manager时不时地找些活来给我，但是还是不够。如果
我硬撑下去, non billable time 就会越来越多。请问如果我请个2，3个星期的病假如
何？
这个主意是不是自讨苦吃？但是如果不想个办法的话，自己会越来越non-billable，到
时候第一个被裁。。。谢谢
ps 不想用vacation, 万一被裁还可以顶几天。

s*y2009-09-16 07:09

4 楼

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*I2009-09-16 07:09

5 楼

just ignore it

【在 u****n 的大作中提到】

: 我看了一下W2，确实是2010年没有扣SS and Med Tax。不过2011年的paycheck上面看到
: 扣了。现在还需要做啥吗？

n*b2009-09-16 07:09

6 楼

no, bad idea

w*l2009-09-16 07:09

7 楼

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.

f*g2009-09-16 07:09

8 楼

totally no point doing so. AND it may back fire and give managers perfect
reasons to let you go since you're idle anyway. AND what if during your 病假
, something comes up?
if they want to get rid of you, they won't care about these 2，3个星期的病假
(and your "rate" looks slightly better).
you don't understand the whole game... companies don't really lay off by
their billable rates like 5% guys go first, 10% guys next...managers don't
use a calculator to do so as you might imagine in your head.
it's all

【在 s********0 的大作中提到】

: 单位里活越来越少，已经有1/5 的人闲下来了，2，3个月后会有更多的人闲下来。
: 我已经闲了很久，和我关系好的manager时不时地找些活来给我，但是还是不够。如果
: 我硬撑下去, non billable time 就会越来越多。请问如果我请个2，3个星期的病假如
: 何？
: 这个主意是不是自讨苦吃？但是如果不想个办法的话，自己会越来越non-billable，到
: 时候第一个被裁。。。谢谢
: ps 不想用vacation, 万一被裁还可以顶几天。

s*y2009-09-16 07:09

9 楼

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.

s*02009-09-16 07:09

10 楼

thanks fryking, truly great advices.
by "GC concern", you mean "green card concern? ie. let them know I'll lose
legal status if losing job?
also by "act actively" do you mean I should look for work instead of
pretending to be busy? if it's hard to find billable project work, is it ok
to help with office chores or look for marketing leads (those are not
billable)?
thanks a lot

n*g2009-09-16 07:09

11 楼

can anyone tell me if sleepy is sleeping

f*g2009-09-16 07:09

12 楼

see below:

【在 s********0 的大作中提到】

: thanks fryking, truly great advices.
: by "GC concern", you mean "green card concern? ie. let them know I'll lose
: legal status if losing job?
: also by "act actively" do you mean I should look for work instead of
: pretending to be busy? if it's hard to find billable project work, is it ok
: to help with office chores or look for marketing leads (those are not
: billable)?
: thanks a lot

w*l2009-09-16 07:09

13 楼

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

m*e2009-09-16 07:09

14 楼

企鹅兄真是职场达人啊...........

those
time
sometimes

【在 f*****g 的大作中提到】

: see below:

s*y2009-09-16 07:09

15 楼

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.

f*g2009-09-16 07:09

16 楼

thanks but no 达人, we all learn from bad experiences and mistakes.

【在 m*******e 的大作中提到】

: 企鹅兄真是职场达人啊...........
:
: those
: time
: sometimes

m*e2009-09-16 07:09

17 楼

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*02009-09-16 07:09

18 楼

【在 m*******e 的大作中提到】

: 企鹅兄真是职场达人啊...........
:
: those
: time
: sometimes

s*82009-09-16 07:09

19 楼

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*02009-09-16 07:09

20 楼

Re.
one last question to fryking is how to deal with office politics now? one
manager is trying to help me, the other clearly doesn't want me to be in his
project (he's just got a big new project) .
in this situation, is it safe to say i won't be able to stay till end of
recession in the firm?

【在 m*******e 的大作中提到】

: 企鹅兄真是职场达人啊...........
:
: those
: time
: sometimes

s*c2009-09-16 07:09

21 楼

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*x2009-09-16 07:09

22 楼

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*x2009-09-16 07:09

23 楼

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.