| API SYNTHESIS AND MANUFACTURING |
Cynthia A. Challener
From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.
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| PEER-REVIEWED RESEARCH |
Eric Olson
This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.
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| BIOLOGICS MANUFACTURING |
Jennifer Markarian
Flow imaging microscopy can be used to identify particulates and their sources.
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| QUALITY|
Denise L. Miller, Carrie A. Shults, Edward H. Trappler
Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.
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| QUALITY CONTROL |
Agnes Shanley
Dissolution testing remains one of the pharmaceutical industry’s most straightforward, least expensive QC tools. Research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality.
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| SUPPLY CHAIN |
Agnes Shanley
Demand for direct-to-patient services is exploding. Michael Sweeney, senior director of patient-centric logistics at World Courier, discusses issues that the new model presents.
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| FROM THE EDITOR |
Rita C. Peters
By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.
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| OUTSOURCING OUTLOOK |
PharmTech Editors
New and expanded facilities point to the continuing growth of the biopharmaceutical industry.
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| US REGULATORY WATCH |
Jill Wechsler
FDA and Congress seek to limit the production and distribution of pain medicines.
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| ASK THE EXPERT |
Susan J. Schniepp
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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