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Pharmaceutical Technology-02-02-2011
Pharmaceutical Technology
Pharmaceutical Technology, February 2011 Issue (PDF)
February 02, 2011
Issue PDF
35
2
Real Time Release Testing
FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 3 - Control of the Drug Product and Stability
February 02, 2011
Special Report
35
2
Chemistry reviewers in FDA's Office of Generic Drugs provide an overview of common deficiencies cited throughout the CMC section of ANDAs.
SMART Bioprocess Design
February 02, 2011
BioForum
35
2
Deep process characterization and "lab-on-a-chip" enable SMART bioprocess design.
Follow-Ons: The New Black?
February 02, 2011
From The Editor
35
2
Follow-ons were all the rage at this year's JP Morgan Healthcare Conference.
Real Time Release Testing
February 02, 2011
Special Report
35
2
Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.
Rogue Pharmacies
February 02, 2011
PharmTech Talk
35
2
Government and private sector efforts take on counterfeit drugs online.
Evaluating Late-Stage Pipelines and Potential
February 02, 2011
Ingredients Insider
35
2
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.
In the Spotlight February 2011
February 02, 2011
In the Spotlight
35
2
New products in tableting and granulation.
Report from India
February 02, 2011
News
35
2
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.
Friend or Foe: Prescription Drug Reimportation in the US
February 02, 2011
Viewpoint
35
2
Legislation has hampered cross-border drug importation and limited choice.
Q&A with Dan Klees, Magnetrol
February 02, 2011
Industry Leaders
35
2
Q&A with Magnetrol International's Dan Klees
FDA Faces Internal Changes and Challenges
February 02, 2011
Washington Report
35
2
Food-safety, transparency, and counterfeit-drug growth will tax agency resources.
Changes Underway for Biopharmaceutical Outsourcing
February 02, 2011
Outsourcing Outlook
35
2
More crucial biomanufacturing operations are expected to be outsourced.
Securing Pharmaceutical Glass Containers
February 02, 2011
Special Report
35
2
Anticounterfeiting solutions for vials and syringes.
Global Healthcare on the Ground: USP
February 02, 2011
News
35
2
USP helps to improve drug quality in 32 countries.
Looking in All the Right Places
February 02, 2011
Agent-in Place
35
2
Taking care to note, file and re-check information can save one from future mishaps.
The Promise and Threat of Quality Risk Management
February 02, 2011
Statistical Solutions
35
2
Using risk assessment properly can provide industry with a unique tool for quality control.
FDA Obtains Sought-After PIC/S Membership
February 02, 2011
Inside PIC/S
35
2
Nearly six years after applying, the FDA joins the Pharma Inspection Co-operation Scheme.
Applying Real Time Release Testing to Powder Processing
February 02, 2011
Online Exclusives
35
2
How to adapt a real time release approach to powder processing during drug-product manufacturing.
Risk-Based Thinking in Process Validation
February 02, 2011
Special Report
35
2
The author describes why statistical significance would impose an unreasonable burden on manufacturers.
Addressing Segregation of a Low-Dosage Direct Blend
February 02, 2011
Peer Reviewed
35
2
The authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.
Preventing Temperature Abuse
February 02, 2011
Packaging Forum
35
2
Innovations protect the quality of temperature-sensitive products.
Real Time Release Testing: Analytical Methods and Innovations
February 02, 2011
Online Exclusives
35
2
A roundtable moderated by Angie Drakulich.