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