Pharmaceutical Technology, Oct 2, 2012 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Oct 2, 2012
Special Report
Combination Drugs: Adding Up the Opportunities
By Patricia Van Arnum
Fixed-dose combination drug therapies give rise to innovation in solid-dosage formulations and manufacturing.
Special Features
Technical Forum: Disposable Chromatography
By Amy Ritter
PharmTech spoke with industry experts about the challenges of implementing disposable chromatography systems.
Applying Quality by Design for Extended Release Hydrophilic Matrix Tablets
By Ian A. Robertson , Sandip B. Tiwari , Tim D. Cabelka
This study examines the effect and interaction of variations in hypromellose physicochemical properties.
Supplier Qualification
By Darcy Ewalt , Tracy L. Cooper , Frithjof Holtz , Irwin Silverstein, PhD
This article provides a comparison of Rx-360, EXCiPACT and IPEA, available to pharmaceutical manufacturers for the purpose of auditing excipient suppliers and ensuring drug efficacy and patient safety.
Peer-Reviewed Research
Obtaining Stable Homogenous Mixtures with Micronized APIs
By H. Leonhard Ohrem , Roberto Ognibene , Thorsten Wedel
The authors examine the use of various grades of direct-compression mannitol in direct-compression tableting process to evaluate the content uniformity of micronized APIs and excipients in a solid-dosage formulation.
Quality by Design for Analytical Methods: Implications for Method Validation and Transfer
By Phil Nethercote , Joachim Ermer
The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.
Integration of Less-Formal Risk Assessment Tools into Change Control
By Kelly Waldron , Marissa Gray
Managing risk in biopharmaceutical operations is of utmost importance for patient protection.
Position Papers
Early Development GMPs for Small-Molecule Specificiations: An Industry Perspective (Part V)
By Michael Coutant , Zhihong Ge , James S. McElvain , Scott A. Miller , Dennis O'Connor , Frank Swanek , Michael Szulc , Mark D. Trone , Kirby Wong-Moon , Mehran Yazdanian , Peter Yehl , Shuhong Zhang
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
Troubleshooting
Outsourcing Pharmaceutical Infrastructure Operations
By Mel Palmer , David Lyons
Today's pharmaceutical companies are striving to reduce costs and maximize efficiencies, and must make decisions on the best way to deploy their limited resources.
From The Editor
A World without R&D
By Angie Drakulich
Will the next US President support the backbone of our industry?
Guest Editorial
Partnerships Remain Crucial to Future Development
By David Mitchell
Working together affords many unseen opportunities for pharmaceutical innovation.
Inside EDQM
Uniformity of Dosage Units Using Large Sample Sizes
By . Holte , M. Horvat
New European Pharmacopoeia chapter aims to resolve problems with applying the harmonized UDU test to large sample sizes.
In the Field
Report from India
By Jane Wan
Foreign firms struggle against stricter patent laws, but all is not lost.
Regulation and Compliance Q&A on 483s
Q&A with David Elder and Richard Wright of Strategic Compliance Consulting, PAREXEL International. Both Elder and Wright formerly served with FDA.
Agent-in Place
Case Closed
By Control, a senior compliance officer
Only the strong survive when it comes to pharmaceutical packaging and shipping.
In the Spotlight
In the Spotlight
New product reviews for October 2012, featuring analytical equipment.
Regulatory Watch
New Era for Generic Drugs
By Jill Wechsler
The promise of the Generic Drug User Fee Amendments of 2012 is to end multiyear reviews of new generic drugs and the ever-growing queue of pending applications.
BioForum
Shifts in Pharma Capital Agendas
By Andrew Forman
The long-awaited patent cliff that has loomed in the pharmaceutical industry for years has arrived in earnest in 2012, with more than $40 billion in 2011 brand sales facing loss of exclusivity.
Statistical Solutions
Tools in Waiting: Time for Evolutionary Operation
By Lynn D. Torbeck
Real-time experimentation may offer continuous process improvement.
Pharma Ingredients
Seeking Solutions in Solid-State Chemistry
By Patricia Van Arnum
Particle-engineering technologies, such as crystal design for crystallization and producting cocrystals, particle-size reduction, and amorphous solid dispersions, help to optimize delivery of a drug.
Advancing Protein Crystallization: Microgravity Effects and Predictive Models
By Patricia Van Arnum
Recent research on elucidating the structure and sequence of proteins involves examining the effect of microgravity on protein crystallization and a computational model for protein elucidation.
Outsourcing Outlook
Sizing the Market for Contract Manufacturing
By Jim Miller
Measuring the size of the market for contract manufacturing services requires a careful hand.
Analytical & Bioanalytical Solutions
Determining Potency of Preclinical Dose Formulations
By Ashley Sanchez , Melissa Whitsel , Amy Smith
Potency is a required measurement to determine the amount of active ingredient contained in a preclinical dose formulation. Assessing potency ensures that the test system receives the appropriate amount of active ingredient based on predetermined specifications.
Industry Leaders
Q&A with James Ingebrand, 3M Drug Delivery Systems Division
A Q&A with James Ingebrand, Vice President and General Manager of 3M Drug Delivery Systems Division, on recent industry trends.
Viewpoint
FDA and the Importance of Confidentiality
By David L. Rosen
Recent news stories have reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.

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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 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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