Pharmaceutical Technology, Feb 2, 2010 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Feb 2, 2010
Online Exclusives
The eCTD Upgrade: Cross-Application Linking
By Michelle Perez
How to cut time and cost by re-using already submitted documents.
Specialty Pharmaceutical Focus: Pancreatic Enzyme Products
By Patricia Van Arnum
A look at the formulation challenges in pancreatic enzyme products.
Breaking Down Barriers to Oral Delivery
By Todd L. Cecil
A recent book provides information about formulating biopharmaceuticals that is easy to swallow.
Special Report
PAT: A New Dawn for Drug Product Quality
By Angie Drakulich , Patricia Van Arnum
Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.
Implications and Opportunities of Applying QbD Principles to Analytical Measurements
By Mark Schweitzer , Matthias Pohl , Melissa Hanna-Brown , Phil Nethercote , Phil Borman , Gordon Hansen , Kevin Smith (Cephalon) , Jaqueline Larew
The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods. This article contain bonus online material.
Ingredients Insider
Advances in Custom Synthesis
By Patricia Van Arnum
As contract manufacturers and drug companies meet at Informex, the stage is set for the latest in pharmaceutical chemical development.
Peer-Reviewed Research
Do Visible Residue Limits Make the 10-ppm Carryover Limit Obsolete?
By Richard J. Forsyth
The author discusses how the use of a visible residue limit has made the 10-ppm cleaning limit obsolete in many applications.
From The Editor
Science and Sensibility
By Michelle Hoffman
The death of a pioneer in molecular genetics recalls age-old questions about social fitness to ensure the ethical uses of scientific advances.
PharmTech Talk
Is the Internet to Blame for Unsafe Drug Use?
By Angie Drakulich
FDA impersonators and counterfeit drugs threaten the public's trust in online pharmacies.
Agent-in Place
The Talk of the Lab
By Control, a senior compliance officer
Sharing too much—or too little—information can have disastrous onsequences.
News
In the Field: Report from Europe
By Sean Milmo
Regulators and industry move to require inspections of API manufacturing facilities.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations
Washington Report
Manufacturers Look to Vaccines for Growth and Innovation
By Jill Wechsler
Vaccine R&D is surging, but continues to raise manufacturing and regulatory challenges.
Insider Solutions
Managing Change Control in a Changing Environment
By Susan J. Schniepp
We never thought implementing complex changes could become more cumbersome.
Outsourcing Outlook
A Bio View of Outsourcing
By Eric Langer
Strategic rather than tactical considerations are driving biopharmaceutical outsourcing.
Industry Leaders: Q&A
Q&A with Jim Vaughan of 3M Drug Delivery Systems
3M Drug Delivery Systems Division Vice President Jim Vaughan discusses facility locations and the drug-product inhalation market.
Viewpoint
Innovation Today, Rewards Tomorrow
By Billy Tauzin
When it comes to healthcare rform, we must not overlook investment in innovative technologies.

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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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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