m********r
发帖数: 127 | 1 这东西也有打折吗？其实我最近也一直想pk pd modeling自学成才一把，不知道有没有
d版的nonmem? lol |
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x****9
发帖数: 36 | 2 有意者请站内联系。
Location：Maryland
JD：
The primary function of a PK Associate Scientist 1/2 is to support Global PK
-PD project leaders and team representatives through all stages of a
candidate drug's development cycle. The PK Associate Scientist 2 will be
responsible for all aspects of PK-related support for biotherapeutics -data
evaluation, interpretation, and reporting. Specifically- preparation of
toxicokinetic reports, clinical PK sub-reports, pre-clinical protocols,
slide preparations, abstracts... 阅读全帖 |
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s****9
发帖数: 213 | 3 An associate scientist position is open in a global biotech company locating
in MD/DC area. As an Associate Scientist I-II in Pharmacokinetics, you’ll
play a pivotal role in supporting clinical pharmacology project leaders and
team representatives through all stages of a candidate drug's development
cycle. You will be responsible for all aspects of PK-related support for
biotherapeutics-data evaluation, interpretation, and reporting. Specifically
- preparation of toxicokinetic reports, clinical... 阅读全帖 |
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l******5
发帖数: 3030 | 4 Contact the recruiter directly please
Principal Research Scientist-PK/PD- Indiana -
The Principal Research Scientist functions as a project leader in a
multidisciplinary team environment with primary responsibility for the early
preclinical development of antibodies and protein molecules.
KEY OBJECTIVES/DELIVERABLES:
- Integrate pharmacokinetics and PK/PD with discovery biology to define
structure activity relationships to guide protein engineering strategies and
to help optimize development of ... 阅读全帖 |
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a*******o
发帖数: 280 | 6 that approach is called naive average
before nonlinear mixed effects modeling was popularized by Sheiner
that was how people characterize the interindividual variability IIV.
however, right now, people more use IIV refering to some ETA terms in NONMEM
.
If you have suffient data, run a NONMEM, good for your resume and job
hunting.
LOL
what a break from the life of two by two matrix, porter's 5, and NPV.
this |
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l*******n
发帖数: 19 | 7 As long as you can write the explicit models for the Pop PK, you can use
statistical software to fit models so Nonmem is not necessary. For example,
there is an example for One-Compartment Pharmacokinetic Model in SAS manual
for sas nlmixed. One advantage of Nonmem is that it contains some standard
modules (like macros) for PK.
In my view, Pop-PK may serve two purposes depending on the data used: if
early stage data are used, Pop-PK may provide guidance for later study
designs; if Phase I |
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H**********J
发帖数: 351 | 8 如题
国内药厂有3个Informatics职位招聘，越看越觉得跟药物研发背景关系不大，跟IT倒是
有巨大关系~大家帮忙看看哈~谢谢啦~
1，Early Development Informatics
Qualifications: M.Sc., Ph.D. or equivalent in Computer Science with a
pharmacology or medical background, or an M.Sc., Ph.D. or equivalent
Pharmacology or Medicine with a strong computer science background, in
addition to experience within the Pharmaceutical or Biotech industry.
Working as a member of Early Development Informatics within Pharma Research
and Early Development Informatics at the Roc... 阅读全帖 |
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s**********r
发帖数: 330 | 9 去问了一下PK/PD组的同事,他们做POPULATION PK/PD MODELING,不用WINNONLIN,用
NONMEM,所以对WINNONLIN也不很熟悉.IN TERMS OF换行,只针对你举的例子,用土办法:
第一行: Variable 1=a+b+c
第二行: Variable 2=d
第三行: Variable 1 + Variable 2
如果你有其他种换行,POST ALONG THE THREAD.我再帮你问问. |
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i**f
发帖数: 1195 | 10 我直接回车的，没事，work的很好
nonmem也一样，都是acii的code，没区别 |
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y***n
发帖数: 27 | 11 也好奇来问一下，
1. PK/PD modeling和biostat的相比，哪个pay的高？比如biostat entry level 一般
pay 8-9w，pk/pd呢?
2.stat phd，with extensive experience in winnonlin,nonmem，在这个行业里是否
不如pk/pd本专业的popular？
因为同学都是做biostat或者marketing的，这个方向缺乏了解，希望版上的牛人们指点
指点 |
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i**f
发帖数: 1195 | 12 I know Winnonlin is required by FDA for individual pk study in industry.
What about population pk? is there any requirement of which software should
be used to conduct the study?
I just browsed the FDA guidance for population pharmacokinetics and didn't
find any information regarding this. it only states "It is crucial that the
software used for population analysis be adequately supported and maintained
."
Does it mean software other than NONMEM can be used, like Monolix? I don’t
want to publis |
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y**g
发帖数: 197 | 13 Anyone know how to call a user-written subroutine from Nonmem? |
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y**g
发帖数: 197 | 14 我还没工作过，所以说的不一定对。
我觉得，PKPD group in the R&D of pharm industry 不需要做实验，你可以google一
下招聘广告，没有要求做bench work的。但有可能你需要设计实验，比如是bolus/
infusion给药，decided the location/frequency/timing of the samples.
就我所知，真正有PKPD的药学院不多，涉及的程度不一样（PKPD, DMPK,CLINICAL
PHARMACUTEICAL SCIENCE). 总之你最好了解PKPD的基本概念，设计模型，有一点统计
知识，会用winnolin/nonmem/splus etc. 就差不多了。
我不清楚这个专业到底好不好找工作。很多公司没有这部门，即使有人数也不多，不能
跟FORMULATION的比。FDA十几年前有了关于PKPD的规定，一个好处是可以少做些实验/
临床，省钱，所以很多公司招人，当时学BME的搞模型的也可以进去。 |
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a*******o
发帖数: 280 | 16 That is OK. I had no idea of PK/PD modeling until I was in my second year.
In vitro ADME is not PK/PD modeling, in industry, in vitro is done in DM
department, sometime it is in DMPK department which also includes PK.
PK/PD modeling is usually in clinical pharmacology department, could also be
pharmacometrics department, or clinical PK department
To get into PK/PD modeling, make sure you have NONMEM, and Splus/R on your
resume |
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a*******o
发帖数: 280 | 17 check out Nick Holford's work. I beleive he loved it.
As matter of fact, the orginal developer of NONMEM, Sheiner and Beal, did
not like the idea of applying Boostrapping with nonlinear mixed effects data
at all.
In the case of pharmacokinetis, most of times, boostrapping was used because
insufficient sample size, and you can not get a good statistical inference
from it. |
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i**f
发帖数: 1195 | 18 thank you yoda! you made it clearer.
from statistical point of view, IIV is the variance of a random variable(
random effect) in the nonlinear mixed effects model frame.The ETA you
mentioned is an estimate of the variance. There is noway to estimate this
variance using the naive average.
One can still characterize the IIV by calculating the standard deviation of
CL but it is not the same thing as the variance talked above.
I am pretty good at NONMEM：）and I am writing my own algorithm to implemen |
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a*******o
发帖数: 280 | 19 interesting, theoretically, non-liner mixed effects modeling is kind of in
the middle of frequentist and bayesian frames. Based on my experiences from
my previous career, FO in NONMEM is reasonable robust, and empirical bayes
can be easily obtained through POSTHOC option.
Anyway,I am sure you will do a great job. :-)
of
implement |
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k******a
发帖数: 306 | 21 代发，If interested, pls contact: d******[email protected]
Looking for a Director/Associate Director in Clinical Pharmacology Modeling
& Simulation for a global leading pharma in Shanghai, China
Qualifications and Responsibilities:
The role requires doctoral-level training (Ph.D., Pharm.D., or M.D.). An
analytical and inquisitive mind for problem solving and strong written and
oral communication skills are essential. You will be working across the
drug discovery pipeline from pre-candidate selectio... 阅读全帖 |
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k******a
发帖数: 306 | 22 代发，If interested, pls contact: d******[email protected]
Seeking a Director of Clinical Pharmacology for a global leading pharma's R&
D in Shanghai, China
Key Responsibilities:
•Contributes to the overall development of long term strategy for
clinical pharmacology in new drug development in China R&D.
•Align & implement clinical pharmacology related strategies to meet
China R&D objectives
•Contribute to clinical pharmacology strategy in early and late stage
studies as well as in re... 阅读全帖 |
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a******d
发帖数: 955 | 23 本人应届国内药学本科毕业，申请美国phd项目，现在有一个clinical pharmaceutical
science 的offer，正在犹豫中。项目中是做clinical trial design, clinical pk,
populational pk modeling等工作。当时申请也是因为对药动感兴趣，但对临床药理的
今后发展，职业规划不是很懂。各位前辈能否从职业发展（我工业、学界没特别偏好）
，工作性质（没有pharmD degree的clinical scientist怎么开展工作？只在实验室分
析样品和数据？）等方面给予指教？另这种专业训练能否做pk/pd?（感觉他们只做了pk
,没有延伸到pd上，虽然有用nonmem什么的）
多谢！ |
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P**e
发帖数: 7 | 25 谢谢菲菲，还有什么老师做博后比较好？哪里可以学NONMEM啊？ |
|
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P**e
发帖数: 7 | 27 谢谢菲菲，还有什么老师做博后比较好？哪里可以学NONMEM啊？ |
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l******o
发帖数: 3764 | 28 本人pharmacology PhD, phd期间是做 drug screen的，后来因为偶然的机会，postdoc
做了PKPD project,发现自己还挺喜欢这个方向的。
虽然至今为止只有不到两年的经验，但是自己感觉上手还算比较快的（和非华裔学生相
比），希望能在model&simulation方向继续发展
我自己的情况：做过的project有两个popPK,一个PKPD，一个NCA，都是clinical data,
不过所有的Project规模都不大,20-100人的样子
popPK/PKPD都是用NONMEM,NCA用的是WinNonlin
R用的还可以，主要用来data formatting / plotting, 虽然写具体的R script经常需
要google帮忙，但是至今为止需要实现的功能还都实现了
我现在的postdoc做到明年6月，准备开始找工作了
希望能找到entry level clinical PK/Pharmacometrics的工作,以M&S为主
公司不限，但是地方最好是great NYC area, great Boston area, 南加，北加，... 阅读全帖 |
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f****6
发帖数: 4472 | 29 大部分in vitro/in situ assay都有很多assumptions，假如你没亲自做过这些assay就
直接拿现成的data做model，再根据你的model下结论，你觉得这样好吗？会不会做出错
误的结论？楼上上glsmfz727也说咯~
做modeling肯定要有较好的统计和programming的基础啦，比如能熟练使用R，MATLAB，
NONMEM，WinNonlin。这些东西你都要会，不过我觉得这些东西都是工具和手段，更重
要的是要对physiology
, pharmacology, action mechanism以及molecule本身了解透彻。大分子的ADME,
action mechanism以及molecule本身都和小分子完全不同，所以才需要这方面的人才嘛。
PKPD我觉得算是现在最好的一个方向了吧，visibility特别高（因为你要代表整个DMPK
组，还要你来做决定），升值加薪快，跳槽也容易。而且FDA也越来越越接受Modeling
了，你要是有相关的filing的经验，那你无敌了~国内这方面还是空白，以后回国应该
也能吃香喝辣：）
随便侃侃，别... 阅读全帖 |
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c********g
发帖数: 1106 | 30 制药界工作机会比较多的modeling种类：
Discovery: PK/PD modeling, PBPK, mechanism based PK/PD, systems pharmacology
modeling （通常在DMPK)
Development: PK/PD (pharmacometrics, use NONMEM, R, monolix), PBPK (use
Gastroplus, simcyp) (通常是专门的modeling组或和clinical pharmacology一起）
掌握modeling&simulation理论的话，这些东西基本能融会贯通。当然并不是什么都能
一下就会了，但是至少很容易有个大致理解。
PBPK可以作为进入这个行业的敲门砖，进去了有很多学习机会，可以慢慢积累做各种模
型的机会，也可以转向DMPK rep或者clinical pharmacology.
PBPK目前有毒理和药理两个主要的领域。毒理主要是辅助环境危险度评价，有社会价值
，但工作机会少。要了解PBPK，窃以为应该从毒理界的文献开始。Hamner Institute是
计算毒... 阅读全帖 |
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h******e
发帖数: 1791 | 31 pk is generally handled by pk scientists who have phd from pharmacology,
clinical pharmacology, pharmacokinetics, pharmaceutical science........and
use nonmem, winnonlin or r. |
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l****a
发帖数: 352 | 32 Winnonlin is used for individual pk and nonmem/r are for pop-pk.
A lot of stat phd are doing pk in big pharms. it does involve pharmacology
ADME but the nonlinear mixed effect modeling do require stat backgroud.
感觉他们也是半个 stat 啊，感觉好多非 stat 专业的都懂一些 stat，真是有压力啊 |
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c*******g
发帖数: 695 | 33 或者和pk部门合作很多
分析phase III的数据
想上来听听经验
需要学NONMEM么？
thanks |
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t**i
发帖数: 688 | 34 Suppose the data for subject #101 is as follows:
ID Date Time Event Glucose
101 01Jan2000 7:30 Sampling .
101 01Jan2000 8:00 Dosing .
101 01Jan2000 8:30 Sampling 100
101 01Jan2000 9:30 Sampling 200
101 01Jan2000 12:30 Sampling 170
101 01Jan2000 18:30 Sampling 140
101 02Jan2000 7:30 Sampling 90
101 02Jan2000 8:00 Dosing .
101 03Jan2000 8:00 Dosing .
101 04Jan2000 8:00 Dosing .
101 05Jan2000 8:00 Dosing .
101 05Jan2000 8:30 Sampling 100
101 05 |
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d*******1
发帖数: 854 | 35 你的问题倒是很具体详细， 就是太难懂了， 能耐下心来读懂的不多， 最好把这个大
问题分割成几个小问题来问。 |
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t**i
发帖数: 688 | 36 Question: in SAS Data Step, is there a way to refer to future records? I
think not, but would like to have it confirmed. |
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y*m
发帖数: 102 | 37 not easy, better sort it by desending order, then do it backwards.
after done, sort it back
or from my previous experience, addl can be calculated by expanding all the
dates in a CDP(constant dosing period), of course you 'll have to know the
start date and end date of each CDP. |
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d*******1
发帖数: 854 | 38 yes, remember SAS holds a record in RAM AT A TIME. So in reality SAS would
not remember the previous records nor foresee the upcoming records unless
special techniques are used (R knows all since everything in RAM).
refering to the "future"records can not be done in a single data step. You
either need to create two datasets and merge them ("current records" from
dataset1 match to "future" records from dataset2) or assign the "future"
records to macro variable in the first data step and later on |
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y*m
发帖数: 102 | 39 I guess I am too bored today,
here is the solution, baozi is very welcome .I added some data to make it
more realistic.
data temp;
input ID $ Date $9. Time $ Event $ Glucose;
time=put(input(time,time5.),tod5.);
cards;
101 01Jan2000 7:30 Sampling .
101 01Jan2000 8:00 Dosing .
101 01Jan2000 8:30 Sampling 100
101 01Jan2000 9:30 Sampling 200
101 01Jan2000 12:30 Sampling 170
101 01Jan2000 18:30 Sampling 140
101 02Jan2000 7:30 Sampling 90
101 02Jan2000 8:00 Do |
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p********a
发帖数: 5352 | 40 赞楼上。。。Good programming skills |
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i**f
发帖数: 1195 | 41 不用看文字，看data就好了
把data1的格式变成data2，加上ADDL和II（additional dose的数量和dosing interval）
data1
D Date Time Event Glucose
101 01Jan2000 7:30 Sampling .
101 01Jan2000 8:00 Dosing .
101 01Jan2000 8:30 Sampling 100
101 01Jan2000 9:30 Sampling 200
101 01Jan2000 12:30 Sampling 170
101 01Jan2000 18:30 Sampling 140
101 02Jan2000 7:30 Sampling 90
101 02Jan2000 8:00 Dosing .
101 03Jan2000 8:00 Dosing .
101 04Jan2000 8:00 Dosing .
101 05Jan2000 8:00 Dosing .
data2 |
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t**i
发帖数: 688 | 42 What if some of dosing records that are not accompanied with blood sampling
events are missing? |
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A*******s
发帖数: 3942 | 43 问问，为啥result data里那个addl是3而不是4呢？后面不是跟了4个dosing的
observation么？
哦，明白了。同一天之后有sampling的不算进addl里面。眼拙了 |
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t**i
发帖数: 688 | 44 When a dosing event/record is accompanied with its corresponding sampling
records, then that dosing record should not be counted toward ADDL. |
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A*******s
发帖数: 3942 | 45 有个细节还不明白，比如说yOm大牛贴出来的那个dataset
101 01Jan2000 7:30 Sampling .
101 01Jan2000 8:00 Dosing .
101 01Jan2000 8:30 Sampling 100
101 01Jan2000 9:30 Sampling 200
101 01Jan2000 12:30 Sampling 170
101 01Jan2000 18:30 Sampling 140
101 02Jan2000 7:30 Sampling 90
101 02Jan2000 8:00 Dosing .
101 03Jan2000 8:00 Dosing .
101 04Jan2000 8:00 Dosing .
101 05Jan2000 8:00 Dosing .
101 05Jan2000 8:30 Sampling 100
101 05Jan2000 9:30 Sampling 200
101 05Jan2000 12:30 Samplin |
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y*m
发帖数: 102 | 46 then there has to be some variable indicating that, I don't see any variable
like that here?
sampling |
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y*m
发帖数: 102 | 47 1) i think not, 'cause there's 06Jan2000 in between without a dosing
2) it was included in my code, 08jan2000 is additional dose for 07jan2000
sampling |
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t**i
发帖数: 688 | 48 To yOm:
After ADDL is obtained, those dosing records that has been counted as part
of ADDL should be deleted. Your code did not do that.
To yOm and Actuaries:
06Jan2000 is a sampling corresponding to the dosing on 05Jan2000. The
records on 07Jan2000 and 08Jan2000 were added by yOm, which do not
necessarily abide the rule of the data set.
Let's concentrate on the data from 01Jan2000 to 06Jan2000.
Essentially, there may be a number of sampling events (the ones on 01Jan2000
and 05Jan2000) follow |
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t**i
发帖数: 688 | 49 There may not be a variable indicating this in the data set to begin with.
However, such information has to be obtained/created in the process of
calculating ADDL.
Let's concentrate on the original example dataset for the time being and
complete it.
variable |
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y*m
发帖数: 102 | 50 really, have you checked my final output dataset, the date from 02jan
through 04jan should have been deleted.
01Jan2000
if |
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