Pharmaceutical Technology, Jul 2, 2008 - Pharmaceutical Technology

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Pharmaceutical Technology, Jul 2, 2008
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A Path to Quality
By Rory Budihandojo
A new book explains process analytical technology, drug stability, and quality.
Self-Emulsifying Drug Delivery Systems
By Ritesh B. Patel , Rakesh P. Patel , Madhabhai M. Patel
This review article explains how self-emulsifying drug delivery systems can increase the solubility and bioavailability of poorly soluble drug.
Special Report
Tipping the Scales in Manufacturing Investment
By Patricia Van Arnum
The pharmaceutical majors invest in biologics production capacity as they advance restructuring programs and build their pipelines
Manufacturing Insights: Pfizer
By Patricia Van Arnum
Natale S. Ricciardi, president of Pfizer Global Manufacturing and senior vice-president of Pfizer, discusses the company's new manufacturing focus that features plant network optimization, increased outsourcing, and greater adoption of agile or lean manufacturing.
A Reality Check on Emerging Markets
By Angie Drakulich
Recent reports discuss the future of pharma's emerging markets.
Peer-Reviewed Research
Variables Affecting Reconstitution Time of Dry Powder for Injection
By Pradip Hiwale , Aeshna Amin , Lokesh Kumar , Arvind K. Bansal
The authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters.
Compliance Risk Management Using a Top-Down Validation Approach
By James P. Agalloco
Patient safety must be the primary concern of any validation effort. The author explains how a risk-based approach to validation and compliance follows naturally from this premise.
Special Section: Polymers
Improved Mass Determination of Poly(ethylene glycols) by Electrospray Ion-Mobility Time-of-Flight Mass Spectrometry Coupled with Ion–Molecule Reactions
By Asish B. Chakraborty , Weibin Chen , John C. Gebler
The authors developed a method to accurately measure the average molecular weight of large poly(ethylene glycols) (PEGs) using ion-mobility time-of-flight mass spectrometry coupled with gas-phase ion–molecule reactions.
The Benefits and Challenges of PEGylating Small Molecules
By Timothy Riley , Jennifer Riggs-Sauthier
Polyethylene glycol (PEG) conjugation is a highly effective technical and commercial strategy to develop macromolecules. The authors explain the benefits and process of PEGylation and how it may be applied to small molecules.
Excipients in Polymeric Drug Delivery and Formulations
By Patricia Van Arnum
A roundtable with John Doney, Jiao Yang, Hans Baer, and Elena Draganoiu.
Washington Report
Celebrating 25 Years of Orphan Drugs
By Jill Wechsler
New scientific discoveries promise to expand treatments for rare and neglected diseases.
Ingredients Insider
Charting API Market Growth and Opportunity
By Patricia Van Arnum
The year 2007 was slow for approvals for new molecular entities and overall pharmaceutical industry growth. Big Pharma seeks relief in a growing biologics portfolio.
Outsourcing Outlook
Help Your Contract Laboratory Help You
By Susan J. Schniepp
Providing the right information upfront may ease new requirements to assess solvent levels.
News
Report From: The Netherlands
By Sean Milmo
A growing preference for public-private partnerships is spurring innovation and technology among Dutch pharmaceutical companies.
Coming Down the Pike: Protein-Substrate Binding
By Michelle Hoffman
Drugmakers seeking to block the activity of a protein may have a new strategy at their disposal.
Trends: Industry Job Cuts
By Angie Drakulich
Staff reductions are not surprising with the state of the economy and falling pharmaceutical sales.
Agent-In-Place
Deviations and Delays
By Control, a senior compliance officer
They may have seemed harmless at first, but these ideas took a big bite.
Viewpoint
ePedigree: Using the Gift of Time Wisely
By Arvindh Balakrishnan
The year 2011 may seem far off, but there is much to do to prepare for electronic pedigrees.
Inside IPEC
Inside IPEC: Dual-Use Labeling
By William D. Carter
Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.
From The Editor
How to Pay for it All?
By Michelle Hoffman
With no economic relief in sight, industry, like all of us, is grappling with high—and new—costs.
PharmTech Talk
Talked to Your Peers Lately?
By Angie Drakulich
Forums, blogs, and more can spark innovation.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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