Pharmaceutical Technology, Aug 2, 2009 - Pharmaceutical Technology

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Pharmaceutical Technology, Aug 2, 2009
Online Exclusives
More Than You Need to Know about Manufacturing Pharmaceutical Proteins
By Roger Dabbah
The author of a book about biopharmaceutical production includes irrelevant information.
A Dubious Foundation for Quality Control
By Eric B. Sheinin, PhD
The author of an ambitious book about quality control falls short of reaching his goals.
Special Report
Big Pharma Tightens Its Belt in Global Manufacturing
By Patricia Van Arnum
In the aftermath of recent restructuring, Big Pharma is sporting a reduced global manufacturing footprint while intensifying its focus to biologics and emerging markets. What will be the look of tomorrow's manufacturing networks?
Peer-Reviewed Research
FDA Perspectives: An Overview of the CDER Drug Recall Root Cause Research Project
By Lynn D. Torbeck , Richard L. Friedman , Michael Smedley
This article provides an overview of the drug Recall Root Cause Research (RRCR) project, an initiative of the US Food and Drug Administration's Center for Drug Evaluation and Research.
Comparison of Authentic and Suspect Pharmaceuticals
By James E. Polli , Stephen W. Hoag , Sharon Flank
The authors applied near-infrared (NIR) spectrophotometry to assess whether eight drug products were authentic or counterfeit.
Formulation and Process Optimization of Cinnarizine Fast-Release Tablets
By Rakesh P. Patel , Ajay Suthar
The authors prepared granules containing cinnarizine using polyethylene glycol 6000 as a melting binder and lactose monohydrate as hydrophilic filler. The effects of binder concentration and size were studied.
Ingredients Insider
Shifting Fortunes in API Market Growth
By Patricia Van Arnum
Biologics enhance their positions amidst slowing growth in the global and US markets.
Insider Solutions
Insider Solutions: Preventing the Next Heparin Scare
By Susan J. Schniepp
Determined to prevent further supply-chain breaches, industry takes charge, offers proposals.
Outsourcing Outlook
Step Carefully into Foreign Affairs
By Jim Miller
As the pharmaceutical industry looks to emerging markets, corruption becomes an important issue.
Washington Report
Pharma Girds for Healthcare Reform
By Jill Wechsler
Pressure to reduce healthcare spending has put drug rebates, price cuts, and tax hikes on the table.
From The Editor
Of Hubris and Happy Endings
By Michelle Hoffman
Individuals and companies at the top seem to have no problem short-circuiting their success.
Packaging Forum
Colder Drugs Will Prevail
By Hallie Forcinio
An expanding number of products and services plug gaps in the cold chain. This article contains bonus online-exclusive material.
Agent-In-Place
Bio Burdens
By Control, a senior compliance officer
An ounce of contamination usually leads to a mountain of investigation.
Viewpoint
Pharma-Biotech Partnerships: Lessons for Personalized Medicine
By Nafees N. Malik
Big Pharma entered biotech too late. That same mistake can be avoided in personalized medicine.
Inside PIC/S
Inside PIC/S: South Africa's Accession to PIC/S
By Joey Gouws
South Africa was the first country on the African continent to become a PIC/S member. The country's Director of Inspectorate and Law Enforcement describes the 10-year process.
PharmTech Talk
For Biotherapeutics, Innovation is Not Enough
By Maribel Rios
Biotech firms must first close the gaps between science and biology on the path toward QbD.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations
Industry Leaders: Q&A
Peter Soelkner of Vetter Pharma
Soelkner discusses the latest industry developments and trends.
News
Report From: China
By Jane Wan
China's State Food and Drug Administration has completed a new draft of GMP guidelines, but after a series of quality-control events, it will take time for the country to regain the global pharmaceutical industry's trust.
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for August 2009.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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