Delving into the Latest Updates on Pfizer Global Manufacturing with Synapse

概览

疾病领域	数量

神经系统疾病	5
感染	2

排名前五的药物类型	数量

小分子化药	7

排名前五的靶点	数量

γ-secretase(γ-分泌酶复合体)	1
GAL3(甘丙肽受体3)	1
IDE	1
SERT(5-羟色胺转运体)	1
L-type calcium channel(L-型电压门控性钙通道家族)	1

关联

7

项与 Pfizer Global Manufacturing 相关的药物

Amlodipine Maleate

马来酸氨氯地平

靶点

VDCCs

作用机制

VDCCs阻滞剂

在研机构

Pfizer Global Manufacturing China

原研机构

Dr. Reddy's Laboratories Ltd.

在研适应症

心绞痛 [+1]

非在研适应症

变异型心绞痛 [+1]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2003-10-31

Sertraline Hydrochloride

盐酸舍曲林

靶点

SERT

作用机制

5-羟色胺重摄取抑制剂

在研机构

Alphapharm Pty Ltd. [+5]

原研机构

Pfizer Inc.

在研适应症

社交恐怖症 [+7]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区-

首次获批日期1990-01-01

Amlodipine Besylate

苯磺酸氨氯地平

靶点

L-type calcium channel

作用机制

L-type calcium channel阻滞剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

英国

首次获批日期1989-03-01

1

项与 Pfizer Global Manufacturing 相关的临床试验

EUCTR2004-000954-22-LV

/ Not yet recruitingN/A

A 1-Year Open-Label Safety Extension Study of Pregabalin (CI-1008) in Patients With Anxiety Disorders

开始日期2004-09-23

申办/合作机构

Pfizer Global Manufacturing

100 项与 Pfizer Global Manufacturing 相关的临床结果

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0 项与 Pfizer Global Manufacturing 相关的专利（医药）

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3

项与 Pfizer Global Manufacturing 相关的文献（医药）

Chimica Oggi

Process analytical chemistry as a tool for green chemistry. Perspectives from an API plant

作者: Berry, L. ; Sistare, F. ; Mojica, C. A.

A review.The use of applied process anal. techniques (PATs), such as online GC and NIR, to solvent recovery operations at an active pharmaceutical ingredients (API) plant is shown with regard to the 12 principles of Green Chem.A good alignment between PAT and benefits in waste reduction (principle 1), energy reduction (principle 6), and in real time monitoring and control (principle 11) was found by applying process online techniques.Waste reduction was obtained from improved solvent recovery efficiencies better than 60% after the implementation of PAT.Using online GC and NIR as PAT the solvent recovery operations eliminated 99% of their test release failures.

Cleaning validation by direct swab NIR analysis

作者: Grout, Bronwyn

Cleaning validation activities are performed to ensure the pharmaceutical production equipment is consistently cleaned to an acceptable level before the next product is manufactured, ensuring product integrity and quality.One of the primary methods of cleaning verification is swabbing of the equipment surface to remove any residue followed by further extraction from the swab into solution for testing by traditional anal. techniques (such as HPLC, GC and UV) or non specific tests such as Total Organic Carbon (TOC).This conventional approach can present difficulties when the anal. methods are not capable.This can occur due to inappropriate limits of detection, chem. inertness or poor solubilities of the residue in acceptable swabbing solvents and poor residue extraction from the swab into solution prior to anal.NIR anal. of the residue direct on the swab was identified as a possible approach for cleaning measurements due to the well established sensitivity of NIR to organic mols.NIR has been overlooked as a tool for cleaning validation despite being widely used in the Pharmaceutical industry for applications such as identification of raw materials and quant. active assay of finished dosage forms.A rapid NIR method was developed for cleaning validation anal. of inert mineral oils at residue levels.Following conventional swabbing with an alc. solvent, the swab was allowed to evaporate to dryness and scanned by a reflectance NIR spectrometer.The method was found to be specific, repeatable and reproducible, with an appropriate limit of detection and sensitivity to establish suitable acceptance limits for linearity data to surpass a limit (Pass/Fail) test and develop a semi-quant. method.The anal. is non-destructive and rapid, requiring no secondary residue extraction, allowing rapid (60% quicker turnaround) feedback of the status of the cleaning and can easily be used by plant operators with no chem. background.

Journal of Process Analytical Chemistry

A chemical sensor based scheme to evaluate packaging containment effectiveness. Part 2: scale-up and qualification of the inspection scheme

作者: Webster, Gregory K. ; Farrand, Douglas A. ; Litchman, Mark A.

A novel testing scheme created for solvent detection was expanded in size to move from a laboratory investigation level to a routine technique scaled up for manufacturing operations.The Sensor Chamber system was developed to replace manual inspection of seal integrity for primary packaging containers.The anal. system tests a pail of product containers placed inside a vacuum chamber.After the product containers are held under vacuum, the chamber is repressurized and the atm. of the chamber is tested for the trace product solvent levels that would occur if the packaging had a lapse in seal integrity.The system presented here is empirical, less tedious and more accurate than manual inspection.The system was optimized for solvent detection, and then validated for use.

100 项与 Pfizer Global Manufacturing 相关的药物交易

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100 项与 Pfizer Global Manufacturing 相关的转化医学

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临床前

2

5

批准上市

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当前项目

药物(靶点)	适应症	全球最高研发状态

苯磺酸氨氯地平 ( L-type calcium channel )	变异型心绞痛更多	批准上市
苯甲醇	虱病更多	批准上市
马来酸氨氯地平 ( VDCCs )	高血压更多	批准上市
杆菌肽 ( IDE )	细菌感染更多	批准上市
盐酸舍曲林 ( SERT )	抑郁症更多	批准上市