Pharmaceutical Technology, May 2, 2007 - Pharmaceutical Technology

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Pharmaceutical Technology, May 2, 2007
Articles
Advancing the Peptide Pipeline
By Patricia Van Arnum
The pharmaceutical majors build their capabilities in peptide technology, and contract manufacturers expand to meet growing demand for bulk peptides.
Review of Current Issues in Pharmaceutical Excipients
By Dorothy Chang , Rong-Kun Chang
Excipients facilitate formulation design and perform a wide range of functions to obtain desired properties for the finished drug product. The article reviews excipient development and functionality of these materials, including their importance in formulation design, potential processing challenges directly related to excipients, and therapeutic benefits.
Eluting Possibilities with Mixed-Mode Chromatography
By Maribel Rios
Mixed-mode chromatography sorbents and custom ligands aim to optimize protein purification.
Inside USP
Dissolution Testing and Metrological Measurement of Quality for Solid Oral Dosage Forms
By Ronald G. Manning, PhD , Samir Z. Wahab, PhD , William E. Brown , Walter W. Hauck, PhD , Stefan Schuber, PhD , Roger L. Williams
USP applies metrological principles to the dissolution procedure alone and in collaborative studies to understand and minimize potential sources of variability.
Outsourcing
Functional versus Full-Service Outsourcing Models
By Jim Miller
Preferred models for clinical and nonclinical services move in opposite directions.
Washington Report
FDA Seeks Streamlined, More Effective GMP Inspections
By Jill Wechsler
Fewer field offices and inspectors will increase reliance on manufacturers to ensure product and process quality.
Viewpoint
Pharmaceutical Benchmarking: A Contract-Manufacturing Perspective
By Shane Ernst
A recent benchmarking report on pharmaceutical manufacturing raises questions about the performance of contract manufacturers, but further analysis also raises concerns about the process and data used to arrive at this conclusion.
Guest Editorial
Public Comment and Expert Oversight: The Cornerstones of USP Standards Development
By Todd L. Cecil
USP exercises a vigorous standards-setting process that draws on both public comments and meticulous scientific review.
Agent-In-Place
Falling to Pieces
By Control, a senior compliance officer
Breaking up is easy to do.
In the Field
May 2007
Sanofi to Close Irish Plant, FDA Inspections and Warning Letters Continue to Decline, FDA Submits Final Proposals for PDUFA IV, and more.

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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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