Pharmaceutical Technology, March 2011 Issue (PDF)
Measuring Spending Levels
Insider Solutions: Reporting Equipment Changes
What to do when your CMO changes the manufacturing equipment line.
Next Steps for the US Biosimilar Regulatory Scheme
With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.
Interphex on Tap
The 2011 show presents ideas for package designs and equipment options for packaging lines.
In the Spotlight March 2011
New product reviews from March 2011.
A First-Hand Look at India's Pharma Services Sector
Indian manufacturers are not a near-term threat to Western CMOs, but may be long term.
A Statistical Approach to Evaluating the Manufacture of Furosemide Tablets
The authors evaluated the manufacturing data of 40-mg tablets of furosemide, a potent diuretic.
Toward Expanding Understanding
A revised book on process analytical technology could be valuable to novices and experts.
Report From Brazil March 2011
Brazil develops its first national plasma fractionation plant.
Evaluation and Characteristics of a New Direct Compression Performance Excipient
The authors investigated the tableting properties of PanExcea MHC300G, a high-performance excipient.
The Benefits of Tablet Tooling Standardization
A single, global tooling standard would offer many benefits, but one has been slow to emerge.
Tips for Selecting Packaging for Pharmaceutical Drug Manufacturers
The author describes key considerations for drug manufacturers when evaluating packaging partners.
Q&A with Robert Hardy, Aesica
Q&A with Robert Hardy, chief executive of Aesica
Is Facebook the Place for FDA?
Social media tools have taken over many aspects of our lives, now including regulatory info.
Inside IPEC: IPEC–Americas Releases Good Distribution Practices Audit Guide
A new audit guide aims to improve supply-chain security and supplier qualification practice.
Quality by Design for Biologics and Biosimilars
The author provides an overview of QbD implmentation for biopharmaceuticals.
One Step Forward, Two Steps Backward
Just when things seem to be looking up, the unexpected problem occurs.
Compliance by Design and Compliance Master Plan
The authors review a compliance-by-design approach to quality systems.
Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2010 and planned for 2011.
Global Healthcare on the Ground: FDA Tackles Rare Diseases
FDA's efforts to improve access to treatments for rare diseases.
A Focus on Emerging Markets
The power of emerging markets is reflected in the pharma's sales and production positions.
Ruggedness of Visible-Residue Limits for Cleaning (Part II)
The author challenges current detection methodologies.
Drug Safety and Shortages Challenge Manufacturers
As drug shortages make headlines, FDA tests the Sentinel safety system and its efect on healthcare.
Standards-Setting Activities of USP's Council of Experts
This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.
Innovation, Intelligence, Passion
INTERPHEX 2011 aims to address the industry's unique characteristics.
