Pharmaceutical Technology, May 2, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, May 2, 2012
Special Reports
Meeting Manufacturing Challenges Tied to Extended-Release Injectables
By Angie Drakulich
Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.
Optimizing Tableting Processes with Quality by Design
By Stephanie Sutton
A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments.
Special Features
FDA Perspectives: Scientific Considerations of Forced Degradation Studies in ANDA Submissions
By Ragine Maheswaran
The author outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions.
Optimizing Drug Delivery for Modern Biologics
By Bart E. Burgess
The author discusses potential opportunities to improve the patient experience through formulation and delivery device technologies.
Troubleshooting
Facilitating Efficient Equipment Cleaning
By Per-Åke Ohlsson
Equipment design and cleaning procedures both play a role in thorough sterilization and cleaning.
From The Editor
Some Supply Chain Lessons Can Go a Long Way towards Success
By Angie Drakulich
Apple's experience with manufacturing facilities in China present opportunity for future best practice.
In the Field
Report from Poland
By Sean Milmo
Poland's government aims to make the Eastern European country a biotech powerhouse.
Regulation and Compliance: 483 Responses
Q&A with David Elder of Strategic Compliance Consulting, PAREXEL International on responding to a 483 within 15 days. Elder is a former senior official with FDA.
PharmTech Talk
Tackling Global Health Concerns
By Patricia Van Arnum
Industry, the public sector, and individuals can play an important role in creating solutions.
Agent-in Place
All Eyes Alert
By Control, a senior compliance officer
It's better to catch costly mistakes in the laboratory before they reach the accounting department.
Regulatory Watch
FDA Explores Options to Expand Access to Non-Rx Drugs
By Jill Wechsler
Manufacturers seek clear path to develop safe-use approaches for more risky OTC therapies.
In the Spotlight
In the Spotlight
New product reviews for May 2012.
Pharma Ingredients
Seeking Chemocatalytic and Biocatalytic Solutions
By Patricia Van Arnum
Advances in palladium-catalyzed hydrogenation, visible-light photocatalysis, and chemocatalyisis for heterocycles are some recent developments.
Formulation Development Forum: Targeted Polymeric Nanoparticles
By Patricia Van Arnum
Targeted polymeric nanoparticles are an important vehicle for controlling and targeting dosing of chemotherapeutic agents.
Outsourcing Outlook
Channeling Steve Jobs
By Jim Miller
Service providers must focus on delivering a superior customer experience.
Viewpoint
The Growing Orphan-Drug Paradigm
By Rita E. Numerof , Michael N. Abrams
How niche strategies can offer mainstream potential for biopharmaceutical companies.

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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
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Expedited reviews of drug submissions
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Reducing drug shortages
70%
Breakthrough designations
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Protecting the supply chain
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Expedited reviews of drug submissions
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More stakeholder involvement
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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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