Pharmaceutical Technology, Feb 2, 2011 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Feb 2, 2011
Industry Leaders
Q&A with Dan Klees, Magnetrol
Q&A with Magnetrol International's Dan Klees
Online Exclusives
Real Time Release Testing: Analytical Methods and Innovations
By Angie Drakulich
A roundtable moderated by Angie Drakulich.
Applying Real Time Release Testing to Powder Processing
By Tim Freeman
How to adapt a real time release approach to powder processing during drug-product manufacturing.
Special Report
Real Time Release Testing
By Angie Drakulich
Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.
Securing Pharmaceutical Glass Containers
By Alexis Pellek
Anticounterfeiting solutions for vials and syringes.
FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 3 - Control of the Drug Product and Stability
By Aloka Srinivasan , Robert Iser , Devinder S. Gill
Chemistry reviewers in FDA's Office of Generic Drugs provide an overview of common deficiencies cited throughout the CMC section of ANDAs.
Risk-Based Thinking in Process Validation
By James P. Agalloco
The author describes why statistical significance would impose an unreasonable burden on manufacturers.
Peer Reviewed
Addressing Segregation of a Low-Dosage Direct Blend
By Nipun Davar , Thomas Baxter , Pauly Kavalakatt , Sangita Ghosh , Herbert Schock
The authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.
From The Editor
Follow-Ons: The New Black?
By Michelle Hoffman
Follow-ons were all the rage at this year's JP Morgan Healthcare Conference.
PharmTech Talk
Rogue Pharmacies
By Alexis Pellek
Government and private sector efforts take on counterfeit drugs online.
Agent-in Place
Looking in All the Right Places
By Control, a senior compliance officer
Taking care to note, file and re-check information can save one from future mishaps.
News
Report from India
By A. Nair
As biologic-drug patents move toward expiration in the US, Indian firms with experience in the follow-on biologics arena are eager to partner with global manufacturers and secure their place in the growing biosimilars market.
Global Healthcare on the Ground: USP
By Angie Drakulich
USP helps to improve drug quality in 32 countries.
In the Spotlight
In the Spotlight
New products in tableting and granulation.
Washington Report
FDA Faces Internal Changes and Challenges
By Jill Wechsler
Food-safety, transparency, and counterfeit-drug growth will tax agency resources.
BioForum
SMART Bioprocess Design
By Albert S. Lee , Mark A. Mynhier
Deep process characterization and "lab-on-a-chip" enable SMART bioprocess design.
Packaging Forum
Preventing Temperature Abuse
By Hallie Forcinio
Innovations protect the quality of temperature-sensitive products.
Statistical Solutions
The Promise and Threat of Quality Risk Management
By Jason J. Orloff
Using risk assessment properly can provide industry with a unique tool for quality control.
Ingredients Insider
Evaluating Late-Stage Pipelines and Potential
By Patricia Van Arnum
Will 2011 be a more promising year for new molecular entities? A review of Big Pharma's late-stage pipeline shows what might lie ahead.
Inside PIC/S
FDA Obtains Sought-After PIC/S Membership
By Joey Gouws
Nearly six years after applying, the FDA joins the Pharma Inspection Co-operation Scheme.
Outsourcing Outlook
Changes Underway for Biopharmaceutical Outsourcing
By Eric Langer
More crucial biomanufacturing operations are expected to be outsourced.
Viewpoint
Friend or Foe: Prescription Drug Reimportation in the US
By Om V. Singh , Thomas E. Colonna
Legislation has hampered cross-border drug importation and limited choice.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
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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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