Pharmaceutical Technology, May 2, 2007 - Pharmaceutical Technology

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PharmTech Europe

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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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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