MAY 2015
Volume 39, No. 5 |
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|Focus|
Agnes Shanley
Stronger pipelines, the need for complex chemistries, and the rise of small- to mid-size innovators are driving demand for small-molecule APIs.
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|Featured content|
Adeline Siew, PhD
Advances in transdermal drug delivery, particularly with microneedles, are enabling a wider range of drugs to be delivered through the skin.
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Randi Hernandez
The rapid testing of biologic raw materials can lead to greater efficiency.
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Ashley Roberts
Compliance with the new traceability requirements necessitates an understanding of how and when to begin implementing changes in an ever-evolving industry.
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|PEER-REVIEWED RESEARCH|
John M. Lindsay
The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.
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|DATA MANAGEMENT|
Ashley Roberts
Transitioning from paper records to electronic batch records decreases costs and increases efficiency.
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Matthew Daniels and Michael Kalvaitis
Virtualization has been mainstream in information technology (IT) for decades.
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|API SYNTHESIS & MANUFACTURING|
Cynthia A. Challener
An integrated pilot plant tests heteronucleation and continuous crystallization.
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|TROUBLESHOOTING|
Doug Kirsch
Tablet press adjustments can prevent manufacturing and product quality problems.
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|OUTSOURCING OUTLOOK|
Eric S. Langer
While the United States and Europe still dominate, CMOs and CROs based in emerging markets continue to capture market share.
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|REGULATORY WATCH |
Jill Wechsler
Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.
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Sean Milmo
The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.
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|OTHER FEATURES |
Stephen Wicks, PhD
The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
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Siegfried Schmitt
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.
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Rita Peters
Pharma can boast of big-picture successes, but needs to work on operational issues.
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Matt Hicks, COO and counsel at Federal Equipment Company discusses purchasing used equipment, the potential cost savings, and the strategies companies should consider in redeploying surplus equipment.
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|Webcasts|
Thursday, May 21, 2015, 11 am EDT
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
Sponsored by: Patheon
Wednesday, May 27, 2015 at 11AM ET
With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.
Sponsored by: Mettler Toledo
Thursday, June 3, 2015, 11 am EDT
Join our free webinar for a case study on the handling of complex manufacturing expansion projects, with insight on simulation and visualization tools, innovations for manufacturing of parenterals, effective team building, and more.
Sponsored by: Baxter
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|Events|
June 01–03, 2015 | Washington, DC
June 02–04, 2015 | Philadelphia, PA
June 15-18, 2015 | Philadelphia, PA
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