Authors
Latest:
Demonstrating the Consistency of Small Data Sets: Application of the Weisberg t-test for Outliersby Robert J. Seely, Amgen, Inc. Louis Munyakazi, John Haury, Heather Simmerman, W. Heath Rushing, and Thomas F. Curry Determining whether a data point is an "outlier" ? a result that doesn't fit, that is too high or too low, that is extreme or discordant ? is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
Latest:
A Statistical Method to Account for Plate-to-Plate Variability in Multiple-Plate Bioassaysby James D. Williams, Virginia Polytechnic Institute and State University, Jeffrey B. Birch, and Steven Walfish Statistics don't lie, but if you don't include appropriate data, the resulting statistical analyses can be misleading. In biopharmaceutical development, if the variability from several different microplates is not addressed, assays testing the relative potency against a standard can be inaccurate. A statistical method that accounts for plate-to-plate heterogeneity is needed ? and presented here.
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SOX in the Boardroom: What the Sarbanes?Oxley Act Means to Youby Penny Cass, BioPharm International Stay current on the changes in corporate governance regulations ? whether your company is public or private, in the United States or elsewhere. As a capital-intensive industry, many of our third-party associations are going to require that biopharmaceutical companies comply with the new regulations to receive financing. The trend to regulate corporate governance activities hasn't ended ? more rules promulgated by more government entities should be anticipated.
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Analytical Advances: Collaborative Effort Results in Automated Cell Culture Systemby Sean Sales, RTS Life Science International RTS Life Science International works with clients to develop modular system.
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The Project Management Institute's Pharmaceutical Specific Interest Group 2002 Benchmark Survey Results: Project Managers and Project Management in the Biotech Industryby Ellis Wilson, AstraZeneca Pharmaceuticals, James McDonough, William Allbee, and Jann Nielsen Compared with their big pharma counterparts, biotech project managers earn more advanced degrees, have fewer years' experience in the industry, and more frequently classify their role as "senior management."
Latest:
The Project Management Institute's Pharmaceutical Specific Interest Group 2002 Benchmark Survey Results: Project Managers and Project Management in the Biotech Industryby Ellis Wilson, AstraZeneca Pharmaceuticals, James McDonough, William Allbee, and Jann Nielsen Compared with their big pharma counterparts, biotech project managers earn more advanced degrees, have fewer years' experience in the industry, and more frequently classify their role as "senior management."
Latest:
Small Biopharms Face Unique Challenges: Outsourcing in Early-Stage Drug Developmentby Bruce Babbitt, PAREXEL International, JanHasker Jonkman, and Paul McKim By partnering with external drug development service providers, small biopharmaceutical start-ups can move their products out of the lab and into clinical development more efficiently.
Latest:
Sialylation Levels Influence Oligosaccharide Quantitation: Analyzing Response Variability Using High-pH Anion-Exchange Chromatography and Pulsed Amperometric Detectionby Chandrashekar Ganesa, Genzyme Corporation, Brian W. Granda, and Robert J. Mattaliano
Latest:
Small Biopharms Face Unique Challenges: Outsourcing in Early-Stage Drug Developmentby Bruce Babbitt, PAREXEL International, JanHasker Jonkman, and Paul McKim By partnering with external drug development service providers, small biopharmaceutical start-ups can move their products out of the lab and into clinical development more efficiently.
Latest:
Collaborating Across the Extended Pharmaceutical Enterprise: How Sharing Information Leads to Process Enablementby Peter Loupos, Aventis Drug Innovation and Approval and Andrew Grygiel A collaborative framework can be a driver for cultural change, encouraging knowledge sharing between internal and external personnel and improving innovation and productivity throughout the enterprise.
Latest:
Collaborating Across the Extended Pharmaceutical Enterprise: How Sharing Information Leads to Process Enablementby Peter Loupos, Aventis Drug Innovation and Approval and Andrew Grygiel A collaborative framework can be a driver for cultural change, encouraging knowledge sharing between internal and external personnel and improving innovation and productivity throughout the enterprise.
Latest:
Sialylation Levels Influence Oligosaccharide Quantitation: Analyzing Response Variability Using High-pH Anion-Exchange Chromatography and Pulsed Amperometric Detectionby Chandrashekar Ganesa, Genzyme Corporation, Brian W. Granda, and Robert J. Mattaliano
Latest:
Survival Strategies: The Life Sciences Industry Turns to eLearningby Susan McLaughlin, Drug Information Association The Drug Information Association unveils the first in a series of professional development programs delivered through eLearning technologies to members worldwide.
Latest:
The Project Management Institute's Pharmaceutical Specific Interest Group 2002 Benchmark Survey Results: Project Managers and Project Management in the Biotech Industryby Ellis Wilson, AstraZeneca Pharmaceuticals, James McDonough, William Allbee, and Jann Nielsen Compared with their big pharma counterparts, biotech project managers earn more advanced degrees, have fewer years' experience in the industry, and more frequently classify their role as "senior management."
Latest:
Small Biopharms Face Unique Challenges: Outsourcing in Early-Stage Drug Developmentby Bruce Babbitt, PAREXEL International, JanHasker Jonkman, and Paul McKim By partnering with external drug development service providers, small biopharmaceutical start-ups can move their products out of the lab and into clinical development more efficiently.
Latest:
The Project Management Institute's Pharmaceutical Specific Interest Group 2002 Benchmark Survey Results: Project Managers and Project Management in the Biotech Industryby Ellis Wilson, AstraZeneca Pharmaceuticals, James McDonough, William Allbee, and Jann Nielsen Compared with their big pharma counterparts, biotech project managers earn more advanced degrees, have fewer years' experience in the industry, and more frequently classify their role as "senior management."
Latest:
BioPharm International's Virus Inactivation Series: A Prefaceby William N. Drohan, Clearant Inc. and Shirley I. Miekka
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BioTrends: M&A Malaiseby Desiree de Myer, BioPharm International Despite market conditions favorable to merger and acquisition activity, a frenzy of consolidations still hasn't taken place.
Latest:
BioPharm International's Virus Inactivation Series: A Prefaceby William N. Drohan, Clearant Inc. and Shirley I. Miekka
Latest:
Sialylation Levels Influence Oligosaccharide Quantitation: Analyzing Response Variability Using High-pH Anion-Exchange Chromatography and Pulsed Amperometric Detectionby Chandrashekar Ganesa, Genzyme Corporation, Brian W. Granda, and Robert J. Mattaliano
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Sponsor-CMO Conflict Management for Clinical-Phase BiologicsThe authors present the CMO's perspective on various potential sources of sponsor-CMO conflicts.
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Modular Cleanroom Facility TrendsModular construction, preassembled modules, and independent structures offer advantages for cleanroom users.
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Modular Cleanroom Facility TrendsModular construction, preassembled modules, and independent structures offer advantages for cleanroom users.
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Stirred-tank Bioreactors in Vaccine Development VideoIn this eBook, Eppendorf experts will give an overview of the most used vaccine platforms and discuss the important role of stirred-tank bioreactors in this life-saving field.
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Freeze-Thaw Performance and Robustness Assessment of Celsius FFT 6LA case study assesses freezing time and physical robustness under stress.
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The Impact of Disposables on Project Economics in a New Antibody Plant: A Case StudyA case study compares capital costs, operating expenses, and NPV for a new MAb plant.
Latest:
Faking ItDrug counterfeiting has become a major problem for the FDA today; a variety of solutions is needed.
Latest:
The Impact of Disposables on Project Economics in a New Antibody Plant: A Case StudyA case study compares capital costs, operating expenses, and NPV for a new MAb plant.
Latest:
The Impact of Disposables on Project Economics in a New Antibody Plant: A Case StudyA case study compares capital costs, operating expenses, and NPV for a new MAb plant.
Latest:
A New Paradigm in Drug DevelopmentThe changing regulatory and manufacturing environment is ushering in a new approach to drug development.
