d*w
发帖数: 546 | 1 请教前辈和大牛们，哪里可以找到 excipients daily uptake limit 的信息?
已经放狗搜过，并查了一些专业网站，好象都语焉不详。哪里可以找到比较详细/确定
的信息呢？
谢谢 |
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m****s
发帖数: 18160 | 2 【 以下文字转载自 Postdoc 讨论区 】
发信人: Chum23 (喜欢春天的人), 信区: Postdoc
标 题: 国内上市企业高薪职位
发信站: BBS 未名空间站 (Tue Mar 4 23:28:49 2014, 美东)
代友转发：诚聘固体制剂研发总监 （职位描述如下）和药物注册专家，有意者请投简
历至Jim Li
-----------------------------------
Process R&D Director of Solid Oral Formulation
Hainan Shuangcheng Pharmaceuticals Co., Ltd. (海南双成药业有限公司)
Location:
China
Contact:
Jim Li
Salary:
80,000.00 - 120,000.00 USD
Type:
Full Time - Experienced
Sector:
Private Industry
Discipline:
Academic / R... 阅读全帖 |
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d*w
发帖数: 384 | 3 erlotinib and gefitinib are not water soluble. what we do for early stage
drug testing in human is to use a cyclodextrin to make the drug soluble.
there are also other excipients to achieve this purpose, but cyclodextrins
are the most commonly used by us.
both USP grade material drugs and excipients can be purchased by research
labs, no need for medical or pharmacy licenses. but you seriously need to
know what you are doing. my suggestion is to find a friend who is studying /
working in pharmace... 阅读全帖 |
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w*********l
发帖数: 5144 | 4 LC-MS used mosted in PK for quantitation, metabolite ID, impurity ID, HPLC
peak purity for method development ect.
GC-MS for trace analysis, residue solvent, clean validation, excipient
quantitation, impurity ID for excipients or drug...
different story for enviromental or food |
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a***g
发帖数: 64 | 5 Pharmceutics and polymer synthesis are two different fields or the job
oppotunities are in different companies. Pharmcaeutics also called
formulation development uses ready-to-used polymers, approved by FDA, as
excipients to manufacture differnt dosage forms. Polymer synthesis probably
have more oppotunities in excipient suppliers, such as Dow, FMC and etc. |
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s**********8
发帖数: 25265 | 6 check USP-NF compendial excipient
or u mean list of Generally recongized as safe (GRAS) excipients from FDA
website. |
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x*******6
发帖数: 994 | 7 Don't send email to me. Please contact Lana Levy at l***[email protected]
Job Title: Formulation Scientist
Location: St. Petersburg, FL
Job Description:
Our client is a leading Drug Development, Advanced Delivery Technology and
Supply partner to the global pharmaceutical industry. A Fortune 1000 company
, with over 20 locations on 5 continents, we partner with 90 out of the top
100 pharmaceutical companies and 44 of the top 50 biotech firms, as well as
thousands of small innovator companies.
I. ... 阅读全帖 |
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c*****a
发帖数: 154 | 8 不一样的，你在药店里应该可以买到，要是找不到的话可以问问药剂师。
OCEAN® Nasal Spray (Fleming)
(buffered isotonic saline)
Description: A 0.65% special saline made isotonic by the addition of a
dual preservative system and buffering excipients prevent nasal irritation.
Ingredients: 0.65% Sodium Chloride and Phenylcarbinol and Benzalkonium
Chloride as preservatives.
Action and Uses: For dry nasal membranes including rhinitis medicamentosa
, rhinitis sicca and atrophic rhinitis. For patients `hooked on nose drops'
and g |
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l*h
发帖数: 4124 | 9 well, by your simple description, the probability of fungal infection is
high. but before starting treatment, you'd better see a doctor (
dermatologist) in person. A test will be done to confirm diagnosis and rule
out those rare but serious systemic conditions (mainly autoimmune):
basically scratch something off and look under a microscope. it is done in
the clinic and doesn't need to be send to a pathology lab and takes about 20
minutes.
OTC anti-fungals cannot be used near eyes or mouth becaus... 阅读全帖 |
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l*h
发帖数: 4124 | 10 well, by your simple description, the probability of fungal infection is
high. but before starting treatment, you'd better see a doctor (
dermatologist) in person. A test will be done to confirm diagnosis and rule
out those rare but serious systemic conditions (mainly autoimmune):
basically scratch something off and look under a microscope. it is done in
the clinic and doesn't need to be send to a pathology lab and takes about 20
minutes.
OTC anti-fungals cannot be used near eyes or mouth becaus... 阅读全帖 |
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p*******8
发帖数: 158 | 11 Can give a talk as to how we do an ANDA through A to Z. Just use some kind
of generic drug as an example. Literature search work, similar product on
market, price, profits and market prospect; then drug substance (API)
analysis (source and purity); formulation work (excipient source and
selection); drug product master files (HPLC methodology development and
validation, physical and chemical constants, other instrumentation and wet
chemistry, dissolution, stability test, relative substances... 阅读全帖 |
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w********h
发帖数: 12367 | 12 来自主题: Macromolecules版 - Job 3 Job Opportunities at Abbott
Job Title: Senior Analytical Chemist
Site Location: North Chicago, IL
Abbott is seeking a polymer scientist with rheology experience to fill an
entry level position in their physicochemical characterization group
DEPARTMENT FUNCTION/OBJECTIVE:
Support the Abbott Technical Operations Functions and the Abbott Technical
Centers worldwide. Resolve physical characterization issues associated with
commercial and research & development drugs, drug products, excipients and
... 阅读全帖 |
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c*********o
发帖数: 1734 | 13 Thanks.
不知道你们公司是做什么的？API or Excipient?
deadline |
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h****J
发帖数: 56 | 14 Elan's Nanocrystal technology is just a bead-milling process to reduce the
crystal size, plus some excipients to stablized the particle size. There is
nothing there worth a Ph.D. research. The point I want to get acrossed: the
industrial-useful technology is not fancy a lot of times, and scientifically
fancy technology many times is not useful, applicable, or ecnomically sound
in industry. One example, supercritical process is a very interesting idea
scientifically and environmentally, but nobod |
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R*j
发帖数: 248 | 15 来自主题: Pharmaceutical版 - 再问个弱问题 traditional (I mean traditional) formulation is art rather than science.
我上学那阵子（多年前乐），我们那压片机砸的片子老裂，找个老工人来折腾一下就好
了。
现如今学校里做formulation的都搞fancy的玩意儿，工业界的主流还是片剂，胶囊，注
射剂。 而且没什么花活， 因为FDA批准的附剂（excipient)就那末几个。在
formulation 上投钱大的大公司恐怕就JNJ（其实就是Alza).
Formulation |
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R*j
发帖数: 248 | 16 来自主题: Pharmaceutical版 - 问个基础问题 Active excipient???
formulation |
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v*******e
发帖数: 107 | 17 来自主题: Pharmaceutical版 - 问个基础问题 active excipient指什么，怎么算呢？ |
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R*j
发帖数: 248 | 18 来自主题: Pharmaceutical版 - 问个基础问题 我是根据你提供的发音猜的，印度口音很重的话，active excipient听着就像ATP,可是
这有什末好算的？？？ I am lost too. Sorry, can't help you.
顺便问一下，你是科班做formulation吗？ |
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c*x
发帖数: 235 | 19 Dear Candidate,
Please contact me in regards to an ANALYTICAL DEVELOPMENT SCIENTIST
position for a pharmaceutical company in IL.
My client is looking for someone that performs development and validation,
performs analytical testing to support product development for drug
substances, in process, intermediates, excipients and drug products.
You may reach me by phone or by e-mail, e-mail is the fastest form of reply
due to many voice mail messages,
I will need a copy of your resume as well as your |
|
R*j
发帖数: 248 | 20 I assume you are talking about a oral sustained dosage form.
What is the point to make "sustained release formulation" for class III drug
(high solubility, low permeability)?
Most available excipients or formulations are very unlikely to enhance drug'
s permeability. (But I do know a company called Emishpere has developed a
novel carrier to facilitate drug permeation across GI tract membrane. Who
knows whether FDA will approve it or not).
Although "Sustained release" won't increase apparent drug |
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E***n
发帖数: 308 | 21 can anyone recommend some good books?
drug formulation: regular recipe and possible drug-excipient interaction
Metabolism: invivo drug degradation, oxidation, hydrolysis...
Thanks. |
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m*****n
发帖数: 5245 | 22 JOB TITLE: Process Development Associate 2
JOB LOCATION: South San Francisco, CA
Job Summary
SUMMARY
Responsible for formulation development of cell and viral vector products
and for characterizing stability of products and process intermediates.
ESSENTIAL FUNCTIONS
Essential functions include but are not limited to the following:
Conducting experiments to evaluate formulations, formulations excipients,
product stability, process intermediate stability and assays;
Measuring product attributes in |
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x***c
发帖数: 6 | 23 Sorry for can't input Chinese. I am desperate to get the CDs for this book,
our original CDs were lost. I are dying for this now, and I don't have money
to buy. thank you for your help.
Handbook of Pharmaceutical Excipients
Source: Pharmaceutical Press
Author(s): Rowe, Raymond C; Sheskey, Paul J; Owen, Sian C
Edition: 5th ed.
Year: 2006
ISBN-10: 1582120587
ISBN-13: 9781582120584
Pages: 850
Thank you very much! |
|
a***g
发帖数: 64 | 24 That is very good info.
I think organic background will help practically in terms of API and
excipient compatability. But if you do not have a degree in pharmaceutics or
pharamceutical sciences, it is a bit hard to get into the field. I know it
is not fair because some people really are good quick learner. Most of the
positions posted need experience e.g. BS with 5-8 years, MS with 2-5 or PhD
without experience or 0-2 years. |
|
j******w
发帖数: 97 | 25 USP is maintained by United States Pharmacopeial Convention, a non-govermental organization.
USP provides enforceable standards for drugs, biologics and excipients: including specs, analytical methods, etc.
The standards published in the USP are enforced by FDA.
Not all drugs are in USP.
If a monograph exists for a drug, it must be strictly adhered to.
Don't know about USP training and certification.
http://www.usp.org/ |
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c*********o
发帖数: 1734 | 26 Recruiter reached me. If you are interested, I can forward your resume to the
recruiter. The position is in Maryland.
**************************************************************************
The Sr. Formulations Scientist will develop formulations that ensure the
stability of biological molecules. Utilize appropriate analytical techniques
to study the physical chemistry of proteins. This position will also study
the chemical stability of proteins in relation to excipient and storage
conditio |
|
|
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s**********8
发帖数: 25265 | 29 来自主题: Pharmaceutical版 - 闲话 GMP 如果一个organization是一个大的, 它既有pipeline的r&d, 也有commercial
production, 那它的gmp的实施就是个art work, 就好比一个女娃娃,发育的啥时候, 该
表现出啥特征. 十三能织素, 十四学裁衣, 十五弹箜篌, 十六诵诗书,十七为君妇, 凹
凹复突突. 说白了其实就是与时俱进. 当一个产品还在proof of concept的时候, GMP
跟本不是concern, 如果这时候花钱搞gmp, 就是败家. GMP应用,其实是在开始做first-
in-man(FIM) trial的时候， 毕竟开始搞人了， 不能乱搞。 当然，control在搞动物
的时候其实已经开始了，preclinical GLP, 畜牲当然要享受高点的待遇。 不过GLP的
scope和GMP
相比，是沧海一粟， 无非是GLP study 人员结构， 样品采集分析， 数据储存，方法
报告撰写等等。。
作FIM的GMP, 其实有些困难，因为regulatory 也没有一个太明晰的大纲。 其实也是可
以理解的， 因为东西千奇百怪， FDA也不是啥都懂。 Annex... 阅读全帖 |
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b**u
发帖数: 2761 | 30 Scientist, Liquid Formulation in Pharmaceutical industry
• Develop liquid, lyophilized, micronized, and nano and sustained
release parenteral formulations of large and small molecules.
• Preformulation characterization of new formulations using various
lab instruments (e.g. HPLC, CE, UV, DSC, ITC, CD, DLS/SLS, Zeta, Rheometer,
etc.).
• Provide data and justification for NCE declaration, CTA, BLA and
NDA submissions for filing in China.
• Formulate stable dosage forms cons... 阅读全帖 |
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a****e
发帖数: 606 | 31 API, excipients, and drug product. I don't think there is regulatory
requirement for intermediates.
The new USP chapter will be effective on Dec 2015. A totally re
-write of the current heavy metal chapter. The effective date is pushed back
from June 2014 because of the resistance from the industry.
Is this change partially triggered by the scandal of gelatin made from waste
leather in china? |
|
x***c
发帖数: 6 | 32 Sorry for can't input Chinese. I am desperate to get the CDs for this book,
our original CDs were lost. I are dying for this now, and I don't have money
to buy. thank you for your help.
Handbook of Pharmaceutical Excipients
Source: Pharmaceutical Press
Author(s): Rowe, Raymond C; Sheskey, Paul J; Owen, Sian C
Edition: 5th ed.
Year: 2006
ISBN-10: 1582120587
ISBN-13: 9781582120584
Pages: 850
Thank you very much! |
|
J****S
发帖数: 15 | 33 请有意回国发展的专业人才联系：d******[email protected]
Title: Scientist, Liquid Formulation
Department: Pharmaceutical Sciences, Discovery Center China R&D and
Scientific Affairs
Report to: Head of Formulation in the Centre for Pharmaceutical
Sciences, Discovery Center, China R&D
Subordinates: Up to 2
PRINCIPAL RESPONSIBILITIES:
• Develop liquid, lyophilized, micronized, and nano and sustained
release parenteral formulations of large and small molecules
• Preformulation char... 阅读全帖 |
|
s**********8
发帖数: 25265 | 34 来自主题: MedicalDevice版 - FDA The Food and Drug Administration (FDA or USFDA) is an agency of the United
States Department of Health and Human Services, one of the United States
federal executive departments. The FDA is responsible for protecting and
promoting public health through the regulation and supervision of food
safety, tobacco products, dietary supplements, prescription and over-the-
counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals,
blood transfusions, medical devices, electromagnetic radiati... 阅读全帖 |
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s**********8
发帖数: 25265 | 35 分析在药厂的工作10%在生物分析. 比如血样, 组织分析和代谢物id. LC/MS是主要工
具.
90%的工作, 在CMC. 如果是对批准的产品的分析, 那就是QC analysis, 按照现成的
方法分析raw material, excipients, drug substance and drug product. 用的方法
都是vlidate的, 或者compendial的, 没啥技术含量了.
R&D 的CMC, 需要很多的分析, 做分析方法的 development 和validation. clinical
trial 之前, 所有的方法要qualify, 不需要validation. phase II结束, phase III
开始之间, 所有方法要validate. 分析的范围有drug substance, drug product,
excipent and raw material. 按照需要做identificatin, assay of content,
impurity(orgnice, inorgnic such as heavy met... 阅读全帖 |
|
s**********8
发帖数: 25265 | 36 分析在药厂的工作10%在生物分析. 比如血样, 组织分析和代谢物id. LC/MS是主要工
具.
90%的工作, 在CMC. 如果是对批准的产品的分析, 那就是QC analysis, 按照现成的
方法分析raw material, excipients, drug substance and drug product. 用的方法
都是vlidate的, 或者compendial的, 没啥技术含量了.
R&D 的CMC, 需要很多的分析, 做分析方法的 development 和validation. clinical
trial 之前, 所有的方法要qualify, 不需要validation. phase II结束, phase III
开始之间, 所有方法要validate. 分析的范围有drug substance, drug product,
excipent and raw material. 按照需要做identificatin, assay of content,
impurity(orgnice, inorgnic such as heavy met... 阅读全帖 |
|
s**********8
发帖数: 25265 | 37 来自主题: MedicalDevice版 - 闲话GMP 如果一个organization是一个大的, 它既有pipeline的r&d, 也有commercial
production, 那它的gmp的实施就是个art work, 就好比一个女娃娃,发育的啥时候, 该
表现出啥特征. 十三能织素, 十四学裁衣, 十五弹箜篌, 十六诵诗书,十七为君妇, 凹
凹复突突. 说白了其实就是与时俱进. 当一个产品还在proof of concept的时候, GMP
跟本不是concern, 如果这时候花钱搞gmp, 就是败家. GMP应用,其实是在开始做first-
in-man(FIM) trial的时候， 毕竟开始搞人了， 不能乱搞。 当然，control在搞动物
的时候其实已经开始了，preclinical GLP, 畜牲当然要享受高点的待遇。 不过GLP的
scope和GMP相比，是沧海一粟， 无非是GLP study 人员结构， 样品采集分析， 数据
储存，方法报告撰写等等。。
作FIM的GMP, 其实有些困难，因为regulatory 也没有一个太明晰的大纲。 其实也是可
以理解的， 因为东西千奇百怪， FDA也不是啥都懂。 Annex好... 阅读全帖 |
|
