Pharmaceutical Technology, Mar 2, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, Mar 2, 2012
Special Reports
Tackling Solubility Challenges
By Patricia Van Arnum
Nanosupensions are among the ways formulation scientists seek to address the problem of solubility.
Platform Technologies
By Erik Greb , Angie Drakulich
The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.
Special Features
Genotoxic Impurities: A Q&A with Amgen's Bo Shen
By Angie Drakulich
Genotoxic impurities and how to identify them and control for them have been a concern for several years in the pharmaceutical manufacturing industry. Pharmaceutical Technology spoke with Bo Shen, PhD, principal scientist at Amgen and chair of the AAPS Pharmaceutical Trace Impurities Focus Group, to gain insight on key challenges.
Peer-Reviewed Research
Evaluating Impurities in Drugs (Part II of III)
By Kashyap R. Wadekar , Mitali Bhalme , S. Srinivasa Rao , K. Vigneshwar Reddy , L. Sampath Kumar , E. Balasubrahmanyam
In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.
From The Editor
FDA Guides the Way to Biosimilars in the US
By Angie Drakulich
Has the long-awaited guidance answered all of the industry's questions?
Inside USP
Inside USP: A Holistic Approach to Supply-Chain Integrity
By Anthony J. DeStefano, PhD , Desmond Hunt
US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.
In the Field
Report from Brazil
By Hellen Berger
Brazil's generic-drug market is growing steadily.
PharmTech Talk
FDA Encourages Whistleblowers, Just Not Its Own
By Amy Ritter
FDA's treatment of whistleblowers lacks internal consistency.
Agent-in Place
Total Recall
By Control, a senior compliance officer
In a world where product recalls can mean the end of a company, all batches must be perfect.
In the Spotlight
In the Spotlight
New product reviews for March 2012.
Regulatory Watch
Communications Advances Present Manufacturer Challenges
By Jill Wechsler
Social media use raises questions about applying old standards to new information technology.
BioForum
Defining Conflict of Interest
By Christopher Milne
The divide between innovation and conflict of interest in medical research is not so clear.
Pharma Ingredients
Securing the Pharma Supply Chain
By Patricia Van Arnum
Regulatory bodies, standard-setting organizations, and industry seek to tackle the problem of counterfeit drugs and securing the flow of pharma ingredients.
Formulation Development Forum: Programmable, Wirelessly Controlled Microchips for Drug Delivery
By Patricia Van Arnum
Wirelessly controlled microchips may offer an alternative to injection-based drug delivery
Outsourcing Outlook
CMOs Face a Kodak Moment
By Jim Miller
The evolving bio/pharmaceutical business model poses risk for CMOs.
Industry Leaders
Q&A with Chris Meissner, Meissner Filtration Products
A Q&A with Chris Meissner, president of Meissner Filtration Products, on recent industry trends.
Viewpoint
Generic Drug User Fees Mark a Step in the Right Direction
By Patty Benson
SOCMA's Bulk Pharmaceuticals Task Force outlines key goals and challenges for user-fee legislation.

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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
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