White Papers

Wednesday, February 08, 2012
Gerresheimer Background Information - A Question of Use
Multilayer plastic parenteral vials with improved barrier properties and increased impact resistance are providing manufacturers with a welcome tool for the delivery of biopharmaceutical formulations Read More
Friday, January 20, 2012
Win With the Networked Drug Development Alliances
Large biopharms are caught between two powerful market forces: the pressure to maximize profits and the need for continual investment in their drug pipelines. For drug development executives, ... Read More
Wednesday, January 18, 2012
KiOmedine-CsU®, The World’s First GMP Ultra-pure Chitosan of Non-animal Origin
In this article, we highlight the features and advantages of KiOmedine-CsU®, an ultra-pure biopolymer from mushroom origin, and show how they benefit to medical and pharmaceutical scientists looking ... Read More
Tuesday, January 17, 2012
Accelerating Generic Approvals
At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter ... Read More
Tuesday, January 17, 2012
Observations on Trends in Outsourcing to Preclinical CROs
Outsourced research services for pharmaceutical discovery and development have emerged as a viable and reliable model for bringing new drugs to market. With the typical investment of more than $800 ... Read More
Tuesday, January 17, 2012
Assessing Risk in Oral Drug Development Programs
The following white paper provides a quantitative approach to assessing risk in oral drug development programs with respect to Chemistry, Manufacturing, and Controls (CMC) activities. Pharmatek’s Drug... Read More
Tuesday, January 17, 2012
Preparing for Mandatory eCTD Submissions to FDA
The electronic Common Technical Document (eCTD) has for some time been the preferred format for applications to FDA, including Investigational New Drug (IND) applications, New Drug Applications (NDA),... Read More
Tuesday, January 17, 2012
Biosimilars: Global Impact of the Biologics Price Competition and Innovation Act of 2009
On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amends the Public Health Services Act (PHS Act) to create an ... Read More
Tuesday, January 17, 2012
Automated In Vivo Sampling
The high cost of pharmaceutical development today, driven by constantly evolving pathologies and healthcare needs, pushes drug developers to pursue operational improvement while striving concurrently... Read More
Monday, December 19, 2011
Managing Cell Based Potency Assays
Characterization of a biological product, which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities, is necessary to ... Read More
Tuesday, December 13, 2011
USP Performance Verification Testing Recommendations and Troubleshooting
The United States Pharmacopeia (USP) Performance Verification Test (PVT) acceptance criteria were significantly altered with the new lot of prednisone tablets, P1I300, released on March 1, ... Read More
Friday, December 09, 2011
Integration of Vial Filler and Lyophilizer
In a typical filling line involving freeze-drying, the lyophilizer is located away from the filling machine, in a separate room or even another part of the facility. As a result, it requires special ... Read More

Gerresheimer Background Information - A Question of Use

Win With the Networked Drug Development Alliances

KiOmedine-CsU®, The World’s First GMP Ultra-pure Chitosan of Non-animal Origin

Accelerating Generic Approvals

Observations on Trends in Outsourcing to Preclinical CROs

Assessing Risk in Oral Drug Development Programs

Preparing for Mandatory eCTD Submissions to FDA

Biosimilars: Global Impact of the Biologics Price Competition and Innovation Act of 2009

Automated In Vivo Sampling

Managing Cell Based Potency Assays

USP Performance Verification Testing Recommendations and Troubleshooting

Integration of Vial Filler and Lyophilizer

White Papers / Application Notes

Accelerating Generic Approvals

Analysis of Drug Degradants by LC/MS

Assessing Risk in Oral Drug Development Programs

Automated In Vivo Sampling

News

ABB Introduces the New MB-Rx for in-situ Reaction Monitoring

Advantest Launches Terahertz Spectroscopic Imaging System TAS7500

Agilent Technologies Adds Sub-2 µm Protein Analysis Biocolumns

Agilent Technologies Lists LC and Mass Spec Systems as Class I Medical Devices with FDA

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