Pharmaceutical Technology, Jan 2, 2010 - Pharmaceutical Technology

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Pharmaceutical Technology, Jan 2, 2010
Online Exclusives
A PAT Solution for Automated Mill Control
By Alon Vaisman , Yanhui Hu
The authors describe the implementation of an on-line particle-size analyzer on an active pharmaceutical ingredient milling operation at a commercial site.
Understanding Biological Indicator Grow-Out Times
By John R. Gillis , Gregg A. Mosley , John B. Kowalski , Garrett Krushefski , Paul T. Nirgenau , Kurt McCauley
This study used biological indicators containing Geobacillus stearothermophilus spores and a new technology to continuously monitor incubated BIs and record nonsterile results.
A Perspective from FDA on ICH Q10 Pharmaceutical Quality System for Contract Manufacturers
By Patricia Van Arnum
Grace McNally, in the Office of Compliance at FDA's CDER, discusses the role of QbD and pharmaceutical quality systems as it relates to contract manufacturing.
A Mass Transfer of Knowledge
By Theodore H. Meltzer
A comprehensive book about mass transfer benefits from the author's personal touch.
Special Report
Quality by Design: Adding Another Dimension to Outsourcing
By Patricia Van Arnum
FDA's quality-by-design initiative is gradually reshaping the paradigm for pharmaceutical manufacturing and the opportunities and challenges in outsourcing.
FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 1: Drug Substance
By Aloka Srinivasan , Robert Iser
Team leaders in FDA's Office of Generic Drugs provide an overview.
Peer-Reviewed Research
The Formulation and Evaluation of Topical Berberine-Hydrochloride Products
By Nikunjana A. Patel , Natvar J. Patel , Rakesh P. Patel , Rakesh K. Patel
The authors sought to prepare a topical formulation of berberine hydrochloride for the effective and controlled management of inflammation and skin infections.
Ingredients Insider
Tracking API Growth
By Patricia Van Arnum
Growth in emerging markets and across the generic-drug sector shifts the global demand and supply of active pharmaceutical ingredients.
From The Editor
Refocusing Our Resources
By Michelle Hoffman
From healthcare to corruption to life expectancy, here's what we can learn from the past decade.
Industry Leaders: Q&A
AAI Pharma's Lee Karras talks about contract-service demand.
Plus, novel dosage forms and emerging trends.
PharmTech Talk
GSK Gets under Your Skin
By Erik Greb
A recent deal could chart new paths in drug delivery and in the administration of vaccines.
Agent-in Place
Personnel Problems
By Control, a senior compliance officer
Directors and staff miss the mark when it comes to following procedures.
News
In the Field: Report from Brazil
By Hellen Berger
Is Brazil's pharmaceutical industry following the consolidation trend?
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations
Washington Report
Pharma Faces Multiple Challenges in the Year Ahead
By Jill Wechsler
Globalization and reform initiatves will shape pharma production, pricing, and pipelines in 2010.
Statistical Solutions
Statistical Solutions: %RSD: Friend or Foe?
By Lynn D. Torbeck
When to use percent relative standard deviation—and how to do so correctly.
Outsourcing Outlook
A Look Ahead for 2010
By Jim Miller
Some predictions for contract services in 2010.
Viewpoint
Healthcare Reform Requires Room for Innovation
By James C. Greenwood
To move from R&D to breakthrough drugs, biotech companies need policies that support innovation.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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