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Pharmaceutical Technology-03-02-2008
Pharmaceutical Technology
Product Annual/Quality Review: US–EU Comparative Analysis and Interpretations
March 02, 2008
Peer-Reviewed Research
32
3
There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.
FDA Seeks Regulatory Flexibility
March 02, 2008
Washington Report
32
3
Quality-by-design submissions may reduce supplements and improve change management.
Time for a World Tooling Standard
March 02, 2008
Viewpoint
32
3
After two centuries, there's no reason to maintain two tablet compression tooling standards.
Holding Back
March 02, 2008
Agent-In-Place
32
3
If not properly monitored, filters and plastic bags can keep back more than they should.
Containers Insulate Companies from Product Loss
March 02, 2008
Packaging Forum
32
3
New packaging options monitor and protect temperature-sensitive products.
Inside USP: Metrology and USP Dissolution
March 02, 2008
Inside USP
32
3
The United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.
Pharmaceutical Technology's Equipment and Machinery Trends Survey
March 02, 2008
Special Report
32
3
The pharmaceutical industry plans moderate increases in spending for equipment and machinery in 2008. Investments include equipment for solid-dosage manufacturing, active pharmaceutical ingredients, and parenteral manufacturing.
Peer-Reviewed Technical Note: Influence of Common Excipients on the Crystalline Modification of Freeze-Dried Mannitol
March 02, 2008
Peer-Reviewed Research
32
3
Mannitol is the most commonly used bulking agent in freeze-drying formulation design. The benefit of using mannitol is that it crystallizes during freezing and permits drying processes at higher product temperatures, and thus with higher sublimation rates relative to purely amorphous systems (1). Mannitol, however, is known to form different crystalline modifications which compromises reproducibility of product characteristics and storage stability due to phase transformations (2, 3).
Changing Fortunes for CMOs
March 02, 2008
PharmTech Talk
32
3
Contract manufacturers of APIs and intermediates are cautiously optimistic.
New Dimensions in Tablet Imaging
March 02, 2008
Special Report
32
3
Chemical imaging of solid dosage forms has become a powerful analytical tool for the development of solid dosage forms.
Raw-Material Authentication Using a Handheld Raman Spectrometer
March 02, 2008
Peer-Reviewed Research
32
3
Using a handheld Raman spectrometer, the authors developed methods for 28 commonly used excipients and active ingredients.
SAFC Sets Forth an Ambitious Growth Strategy
March 02, 2008
Online Exclusive
32
3
SAFC is delivering on its plan for double-digit annual growth by increasing its businesses through organic growth and targeted technology acquisitions.
Salt Selection in Drug Development
March 02, 2008
Peer-Reviewed Research
32
3
The selection of an appropriate salt form for a potential drug candidate is an opportunity to modulate its characteristics to improve bioavailability, stability, manufacturability, and patient compliance.
In the Spotlight March 2008
March 02, 2008
In the Spotlight
32
3
Editors' Picks of Pharmaceutical Science & Technology Innovations; Analytical system provides multiuser capability; Encapsulator aids dosage design; Versatile drive offers quick setup
A Changing Path in Global Sourcing
March 02, 2008
Ingredients Insider
32
3
The European Union's REACH initiative has the potential to affect the flow of chemicals into the pharmaceutical suppy chain.
Guest Editorial: Interphex Focuses on Evolution of the Life Sciences
March 02, 2008
Guest Editorial
32
3
Show blasts off this month in Philadelphia with more suppliers, new trends, and real-world solutions.
Innovation in Equipment and Machinery
March 02, 2008
Special Report
32
3
Results from Pharmaceutical Technology's Equipment and Machinery Trends survey and industry members provide insight into product innovation
Outsourcing Outlook: API Manufacturers Go From Grams to Tonnes
March 02, 2008
Outsourcing
32
3
CMOs have positive outlook for 2008 but are wary of competitive pressures.
Innovation at Interphex
March 02, 2008
Online Exclusive
32
3
A preview of some product enhancements and launches for Interphex 2008, the large trade show being held Mar. 26–28 in Philadelphia.
Peer-Reviewed Topical Review: The Importance of Quality in Corrosion-Resistant Alloys in Biopharmaceutical Manufacturing
March 02, 2008
Peer-Reviewed Research
32
3
In this topical review, the authors discuss the rationale behind microstructural requirements for biopharmaceutical equipment and problems that may be encountered during the fabrication of high-performance corrosion-resistant equipment.
Packing-Line Improvement Based on a Fault-Tree Analysis Approach
March 02, 2008
Peer-Reviewed Research
32
3
This article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.