Pharmaceutical Technology, Aug 2, 2011 - Pharmaceutical Technology

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Pharmaceutical Technology, Aug 2, 2011
Online Exclusive
A Quality-Control Guide Fails to Train the Trainer
By Roger Dabbah
A book about developing quality-control training manuals provides a wealth of information and a dearth of practical help.
Special Report
Big Pharma's Manufacturing Blueprint for the Future
By Patricia Van Arnum
The pharmaceutical majors continue rationalizing manufacturing capacity in established markets as they forge their manufacturing networks in biologics and emerging markets.
Chemical Confirmation
By Alexis Pellek
Analytical detection techniques help combat counterfeit drugs.
Q&A: Thin-layer Chromatography Kits Screen for Counterfeits in Developing Countries
By Alexis Pellek
Thomas P. Layloff describes the advantages of using thin-layer chromatography methods for counterfeit detection. This article contains bonus online material.
Special Feature
PQRI Case Study (2): Functional Equivalence for Equipment Replacements
By Ted Frank , Stephen Brooks , Kristin Murray , Steve Reich , Ed Sanchez , Brian Hasselbalch , Kwame Obeng , Richard Creekmore
The second in a series of eight case studies from the Product Quality Research Institute focuses on functional equivalence for equipment.
Peer-Reviewed Research
Controlled Crystallization During Freeze-Drying
By Hans de Waard , Niels Grasmeijer , Wouter L.J. Hinrichs , Thomas De Beer , Henderik W. Frijlink
The authors discuss the preparation of lipophilic drug nanocrystals by controlled crystallization during freeze-drying.
Understanding Fluidized-Bed Granulation
By A. Burggraeve , T. Van Den Kerkhof , M. Hellings , J.P. Remon , C. Vervaet , T. De Beer
This study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.
Controlled Release from Porous Platforms
By Spomenka Simovic , Dusan Losic , Krasimir Vasilev
The authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.
From The Editor
Biosimilars or Bust
By Michelle Hoffman
Are biosimilars the next big thing or just the next big bubble?
PharmTech Talk
Prophylaxis in a Patch
By Erik Greb
New studies reveal the promise and feasibility of transdermal vaccine delivery.
Agent-in Place
Movin' On Out
By Control, a senior compliance officer
Visiting a new site or going down memory lane may not get you where you want to go.
News
Report from Asia
By Jane Wan
Contract manufacturing organizations throughout Asia are increasing their capabilities to meet market demand and attract foreign investment and partnerships.
Global Healthcare on the Ground: NIH Aims to Help Treat 200 Rare Diseases
By Angie Drakulich
NIH leads new international consortium to develop a diagnostic tool for most known rare diseases by the year 2020.
In the Spotlight
In the Spotlight
New product reviews for August 2011 focusing on automation, process control, and information technology.
Washington Report
Washington Report: FDA Maps Strategy to Counter Supply-Chain Threats
By Jill Wechsler
Rising imports and overseas production spur realignment of enforcement.
BioForum
Embarking on the New World of Personalized Medicine
By Albert S. Lee , Ash Malik , Mark A. Mynhier
A path to personalized medicines creates a new paradigm for development and manufacturing.
Statistical Solutions
Reducing the Risk in Risk Management
By Lynn D. Torbeck
A firm grasp of probability and ongoing re-evaluation are key.
Packaging Forum
Performing Double Duty
By Hallie Forcinio
Many child-safe package designs help improve compliance and provide tamper evidence.
Pharma Ingredients
Improving API Synthesis
By Patricia Van Arnum
O-arylation and O-alkylation, a one-pot protein synthesis, a combined approach in continued and chemocatalysis, and green-chemistry applications are the target of some recent advances in API synthesis.
Inside USP
Inside USP: International Dialogue on Biologics Standards
By Tina S. Morris
USP promotes horizontal standards for biologics' quality attributes.
Outsourcing Outlook
Offshoring Biomanufacturing
By Eric Langer
China rises to the top as a destination for international outsourcing.
Industry Leader
Q&A with Terry Novak, Norwich Pharmaceuticals
Terry Novak, president of Norwich Pharmaceuticals, on recent industry trends.
Viewpoint
Has Outsourcing Derailed PAT and QbD?
By Daniel R. Matlis
Quality management requires more effort in a complex supply chain.

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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
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Expedited reviews of drug submissions
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Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
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Expedited reviews of drug submissions
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More stakeholder involvement
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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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