Pharmaceutical Technology, Mar 2, 2011 - Pharmaceutical Technology

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PharmTech Europe
Pharmaceutical Technology, Mar 2, 2011
Online Exclusives
Tips for Selecting Packaging for Pharmaceutical Drug Manufacturers
By Fran l. Degrazio
The author describes key considerations for drug manufacturers when evaluating packaging partners.
Toward Expanding Understanding
By R. Christian Moreton
A revised book on process analytical technology could be valuable to novices and experts.
Special Report
Measuring Spending Levels
By Patricia Van Arnum
Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2010 and planned for 2011.
Quality by Design for Biologics and Biosimilars
By Anurag S. Rathore
The author provides an overview of QbD implmentation for biopharmaceuticals.
Special Feature
Compliance by Design and Compliance Master Plan
By Paul L. Pluta , Richard Poska , Timothy J. Fields
The authors review a compliance-by-design approach to quality systems.
Standards-Setting Activities of USP's Council of Experts
By USP Council of Experts and USP Staff
This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.
Peer Reviewed
A Statistical Approach to Evaluating the Manufacture of Furosemide Tablets
By Túlia de Souza Botelho , Vanessa Franco Tavares , Cátia Panizzon Dal Curtivo , Silvie Rosa Balzan Sarolli , Marcio Adriano Fernandes , Carmen Maria Dunaduzzi , Raimar Löbenberg , Nádia Araci Bou-Chacra
The authors evaluated the manufacturing data of 40-mg tablets of furosemide, a potent diuretic.
Evaluation and Characteristics of a New Direct Compression Performance Excipient
By Liliana A. Mînea , Rajendra Mehta , Madhu Kallam , James A. Farina , Nandu Deorkar
The authors investigated the tableting properties of PanExcea MHC300G, a high-performance excipient.
Ruggedness of Visible-Residue Limits for Cleaning (Part II)
By Richard J. Forsyth
The author challenges current detection methodologies.
Guest Editorial
Innovation, Intelligence, Passion
By Bob Stewart
INTERPHEX 2011 aims to address the industry's unique characteristics.
PharmTech Talk
Is Facebook the Place for FDA?
By Angie Drakulich
Social media tools have taken over many aspects of our lives, now including regulatory info.
News
Report From Brazil
By Hellen Berger
Brazil develops its first national plasma fractionation plant.
Global Healthcare on the Ground: FDA Tackles Rare Diseases
By Christina I. Ortiz
FDA's efforts to improve access to treatments for rare diseases.
In the Spotlight
In the Spotlight
New product reviews from March 2011.
Agent-in Place
One Step Forward, Two Steps Backward
By Control, a senior compliance officer
Just when things seem to be looking up, the unexpected problem occurs.
Washington Report
Drug Safety and Shortages Challenge Manufacturers
By Jill Wechsler
As drug shortages make headlines, FDA tests the Sentinel safety system and its efect on healthcare.
BioForum
Next Steps for the US Biosimilar Regulatory Scheme
By David Rosen , Larry Lian
With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.
Packaging Forum
Interphex on Tap
By Hallie Forcinio
The 2011 show presents ideas for package designs and equipment options for packaging lines.
Ingredients Insider
A Focus on Emerging Markets
By Patricia Van Arnum
The power of emerging markets is reflected in the pharma's sales and production positions.
Insider Solutions
Insider Solutions: Reporting Equipment Changes
By Susan J. Schniepp
What to do when your CMO changes the manufacturing equipment line.
Inside IPEC
Inside IPEC: IPEC–Americas Releases Good Distribution Practices Audit Guide
By Irwin Silverstein, PhD
A new audit guide aims to improve supply-chain security and supplier qualification practice.
Outsourcing Outlook
A First-Hand Look at India's Pharma Services Sector
By Jim Miller
Indian manufacturers are not a near-term threat to Western CMOs, but may be long term.
Industry Leaders
Q&A with Robert Hardy, Aesica
Q&A with Robert Hardy, chief executive of Aesica
Viewpoint
The Benefits of Tablet Tooling Standardization
By Steve Deakin
A single, global tooling standard would offer many benefits, but one has been slow to emerge.

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Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
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