Pharmaceutical Technology, Apr 2, 2011 - Pharmaceutical Technology

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Pharmaceutical Technology, Apr 2, 2011
Special Report
Scrutinizing the Subvisible
By Erik Greb
Regulators question whether particles that they can't see hurt patients.
US Steps Up Scrutiny of Foreign Transactions
By Carlos F. Ortiz , Michael Goldkang
Companies engaged in global mergers and acquisitions may be hearing from the Department of Justice more often to ensure that corruptive practices are not taking place.
Special Feature
FDA Perspectives: Common Deficiences in Abbreviated New Drug Applications (Part 4)
By Aloka Srinivasan , Robert Iser
FDA reviewers aim to assist ANDA sponsors in building quality into their submissions by clarifying components of the applications. Part 4 addresses manufacture and container closure.
Revisiting Interventions in Aseptic Processing
By James P. Agalloco , James E. Akers
The authors revisit their previous effort to refine the terms that describe interventions and to dispel confusion that arose after the original article was published.
Peer-Reviewed Research
Delivering Tamoxifen within Solid Lipid Nanoparticles
By Roghayeh Abbasalipurkabir , Aref Salehzadeh , Rasadee Abdullah
The aim of this study was to prepare and characterize physiochemically and biologically tamoxifen-loaded SLNs to evaluate their effectiveness as a drug-delivery system to treat breast cancers.
From The Editor
Celebrity Couples to Disunite
By Michelle Hoffman
Research and development may be headed for divorce.
PharmTech Talk
A QbD World for Suppliers
By Patricia Van Arnum
The need for greater process understanding raises the bar for suppliers.
Agent-in Place
Inspections Gone Mad
In any industry, inspections can be a pain, and pharma is no exception.
News
Report From China
By Jane Wan
The contract-research industry in China is growing in leaps and bounds, and Big Pharma is leading the way.
Global Healthcare on the Ground: Framework Set for Supply-Chain Improvement
By Christina I. Ortiz
PRTM helps to improve supply-chain management and logistics in developing countries.
In the Spotlight
In the Spotlight
Editor's picks of analytical instrumentation products for April 2011.
Washington Report
Health-Reform Controversies
By Jill Wechsler
Courts and Congress seek to reshape policies and programs.
BioForum
Biotechnology Loses Lead in Funding
By Tracy T. Lefteroff
An uncertain regulatory environment affects funding for biotechnology.
Statistical Solutions
Pitfalls in Statistics
By Lynn D. Torbeck
The hardest errors to spot are the ones that don't look like errors at all.
Ingredients Insider
Advancing Small-Molecule Synthesis
By Patricia Van Arnum
Chemocatalytic and biocatalytic routes play an important role in improving the manufacture of intermediates and active pharmaceutical ingredients.
Inside PDA
PCMO Initiative Gathers Strength
By Richard Levy
A review of current efforts within PDA's Paradigm Change in Manufacturing Operations initiative.
Outsourcing Outlook
A Hard Look at Third-Party External Supply Networks
By Gregg Brandyberry
The complexity of third-party external supply networks requires new ways to manage them.
Industry Leaders
Q&A with Bob Weaver, HunterLab
Bob Weaver, president of HunterLab, discusses current trends and challenges.
Viewpoint
When Patience Pays Off
By John Castellani
PhRMA efforts of industry's R&D scientists.

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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 LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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