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Friday, October 26, 2012
The Global Pharmacovigilance Landscape—Considerations Beyond the US and the EU
The World Health Organization describes pharmacovigilance as the process of detecting, assessing, understanding, and preventing adverse events associated with medicinal products, with the aim of ...
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Monday, October 22, 2012
Rapid Mycoplasma Testing Service Delivers Speed, Sensitivity and Specificity to a Broad Scope of Sample Matrices
Mycoplasma are the smallest known self-replicating prokaryotes. They parasitize a wide range of host organisms, including humans, animals, plants and insects and are common contaminants of mammalian ...
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Friday, September 28, 2012
Extractables and Leachables for Pharmaceuticals and Medical Devices
Our industry continues to be challenged by Extractables and Leachable (E&L) studies due to their late stage occurrence and investigational nature. These projects must first identify and then show ...
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Thursday, September 06, 2012
Specialized Techniques for Developing ODT Dosage Forms
Orally disintegrating tablets (ODTs) are unique dosage forms that facilitate improved patient convenience and compliance. However, they also come with unique formulation and manufacturing challenges, ...
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Monday, August 20, 2012
Keeping Bad Bugs Out of Good Products
No pharmaceutical company wants to sell a non-sterile drug which is contaminated with objectionable microorganisms, but how does a company know which organisms are objectionable and how do they ensure...
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Tuesday, August 07, 2012
Selecting a Laboratory for Pharmaceutical Stability Testing
Because stability testing must be performed to the standards of the FDA and other government agencies, the protocols are rigorous, the procedures are highly regulated and both staff and equipment are ...
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Wednesday, July 25, 2012
Enabling the Future of Cardiac Research with Pre-Clinical CT Imaging
Cardiovascular diseases cause approximately 30% of mortality in industrialized nations, and finding treatments, and ultimately cures, is of great interest to the biomedical research community. ...
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Tuesday, June 05, 2012
Solvent Considerations in Solid-Dose Manufacturing
Solid-dose tablet and capsule manufacturing is a mainstay of the pharmaceutical industry, as it results in a consistent, effective, and economical platform for drug delivery. Not only are tablets and ...
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Friday, June 01, 2012
The Benefits of Applying Lean Manufacturing Techniques to the Preparation of High-Purity Formulations
As global competition and cost pressures continue to grow across every industry, many organizations are searching for ways to apply lean manufacturing principles from their production environments to ...
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Thursday, May 10, 2012
Changes in ISO 14644-1 to Improve Confidence in Quality for Critical Life-science Applications
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness is under revision as part of the normal ISO periodic review cycle. An international working ...
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Thursday, May 10, 2012
The Benefits of Using AAIPharma Services for Elemental Impurity Analysis Using ICP-MS Technology
Metal impurities have historically been monitored in drug articles intended for use by humans and animals. Drug articles include active pharmaceutical ingredients (API), excipients, drug products and ...
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Friday, April 20, 2012
AccuPRO-ID® - Bacterial Identification Using MALDI-TOF Technology
Accurate classification of unknown bacterial isolates is an essential first step in understanding the impact these organisms have on an environmental monitoring program. Accugenix offers various ...
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Friday, April 20, 2012
Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations
A thorough evaluation process for microbial identification systems should consist of both a technical and financial review, regardless if you are performing internal testing and outsourcing. All ...
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Thursday, March 22, 2012
Case Study of a New Growth-Based Rapid Microbiological Method (RMM) That Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count
Currently available growth-based rapid microbiological methods (RMM) provide either a quantitative cell count, estimation of viable cell concentration, information regarding the presence of a ...
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Monday, March 05, 2012
Determination of Counterfeit Drugs
Counterfeit drugs are a substantial and growing problem, both in the developed and in the developing world.
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White Papers / Application Notes
A Comprehensive Strategy to Evaluate Single-use Bioreactors for Pilot-scale Cell Culture Production
Wednesday, June 13, 2012
A Generic HPLC/UV Platform Method for Cleaning Verification
Thursday, October 25, 2012
A Rational Approach to Development and Validation of Dissolution Methods
Monday, April 08, 2013
A Review of Reported Recalls Involving Microbiological Control
Friday, March 09, 2012
News
Agilent Technologies Introduces Verified Dissolution Components for Pharmaceutical Market
Thursday, May 16, 2013
Merck Serono and Quintiles Announce Innovative Clinical Development Partnership
Thursday, May 16, 2013
AbbVie and Alvine to Collaborate on Investigational Oral Therapy for Celiac Disease
Tuesday, May 14, 2013
Halo Pharma and Altus Formulation Announce New Formal Collaboration
Tuesday, May 14, 2013