Pharmaceutical Technology, Oct 2, 2008 - Pharmaceutical Technology

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Pharmaceutical Technology, Oct 2, 2008
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To-Do List for 2009
By Hallie Forcinio
Planning ahead will ensure successful efforts to improve packaging and packaging operations.
Integration the Easy Way
By Erik Greb
Pharmaceutical companies want software vendors to make integrating manufacturing execution systems and enterprise resource planning systems easier.
Are You Ready for REMS?
By R. Gary Hollenbeck
A book offers a detailed introduction to the new area of risk evaluation and mitigation strategies.
Special Report
Putting Together the Pieces
By Erik Greb
Several strategies and software applications help pharmaceutical companies integrate their manufacturing execution systems and enterprise resource planning systems.
Peer-Reviewed Research
Effect of Binder Type and Binder Level on the Properties of Agglomerates Containing Lactose and Dibasic Calcium Phosphate Dihydrate
By Anita Lalwani , Jolly Parikh
The authors studied the effect of the combination of binders on the flow and compressibility characteristics of the agglomerates of binary combination of lactose and dibasic calcium phosphate dihydrate.
Review of Changes in Topical Drug Product Classification
By David W. Osborne
This article summarizes the classification systems for topical liquid and semisolid dosage forms used for dermatological application and notes some differences between FDA and USP classification.
Peer-Reviewed Technical Note: Quality by Design in Freeze-Drying
By Henning Gieseler, PhD , Tony Kramer , Stefan Schneid
Cycle design and robustness testing using advanced process analytical technology.
Ingredients Insider
Outsourcing Strategies of Emerging Pharma
By Patricia Van Arnum
Emerging pharmaceutical companies represent an important client base for CROs and CMOs. Lessons learned for successful customer–supplier relations.
Articles
Continuous Mixing of Solid Dosage Forms via Hot-Melt Extrusion
By Charlie Martin
The author describes the benefits, processes, and practicality of using hot-melt extrusion to mix active pharmaceutical ingredients with pharmaceutical-grade polymers.
EC Reviews: An Executive Country Review on Turkey
By Ece Vatansever , Lina Serafini , Guillaume Doane
In the wake of economic growth, healthcare reforms, and large-scale industry investment, Turkish pharmaceutical companies are charting their own destiny.
Outsourcing Outlook
Minding Your P's and Q's
By Jim Miller
As offshore savings decline, pharmaceutical companies still have a lot of work to do to reduce costs.
Washington Report
FDA Proposes Flexible Oversight for Quality Systems
By Jill Wechsler
Manufacturers seek real-world benefits from investment in QbD and risk-management strategies. This article contains bonus online-exclusive material.
Agent-In-Place
Human After All
By Control, a senior compliance officer
To err may be human, but to really mess things up, you need management.
Viewpoint
A Case for Developing a Standards-Based Approach to Plug-and-Play Equipment
By Scott W. Sommer
Industry needs a standard to connect systems and equipment sooner rather than later.
From The Editor
The Past as Prologue
By Michelle Hoffman
Can previous trends of Democratic and Republican administrations predict industry's future?
News
Report From: Europe
By Sean Milmo
Although the European Union's approval rates of biosimilars for market is increasing slower than expected, its approach may provide an example for other foreign markets.
Trends: NAS Launches and NME Approvals Rise and Fall
By Erik Greb
A recent report shows a decline in NASs and a rise in NME applications in 2007.
PharmTech Talk
Complex Science
By Angie Drakulich
Advancements add yet another challenge for industry's already overextended regulatory body.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for October 2008.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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