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Pharmaceutical Technology-10-02-2012
Pharmaceutical Technology
Pharmaceutical Technology, October 2012 Issue (PDF)
October 02, 2012
Issue PDF
36
10
Combination Drugs - Adding Up the Opportunities in Solid Dosage
Integration of Less-Formal Risk Assessment Tools into Change Control
October 02, 2012
Peer-Reviewed Research
36
10
Managing risk in biopharmaceutical operations is of utmost importance for patient protection.
Technical Forum: Disposable Chromatography
October 02, 2012
Special Features
36
10
PharmTech spoke with industry experts about the challenges of implementing disposable chromatography systems.
Uniformity of Dosage Units Using Large Sample Sizes
October 02, 2012
Inside EDQM
36
10
New European Pharmacopoeia chapter aims to resolve problems with applying the harmonized UDU test to large sample sizes.
Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)
October 02, 2012
Position Papers
36
10
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
A World without R&D
October 02, 2012
From The Editor
36
10
Will the next US President support the backbone of our industry?
Quality by Design for Analytical Methods: Implications for Method Validation and Transfer
October 02, 2012
Peer-Reviewed Research
36
10
The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.
Supplier Qualification
October 02, 2012
Special Features
36
10
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.
Advancing Protein Crystallization: Microgravity Effects and Predictive Models
October 02, 2012
Pharma Ingredients
36
10
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.
Determining Potency of Preclinical Dose Formulations
October 02, 2012
Analytical & Bioanalytical Solutions
36
10
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.
Report from India
October 02, 2012
In the Field
36
10
Foreign firms struggle against stricter patent laws, but all is not lost.
Tools in Waiting: Time for Evolutionary Operation
October 02, 2012
Statistical Solutions
36
10
Real-time experimentation may offer continuous process improvement.
Outsourcing Pharmaceutical Infrastructure Operations
October 02, 2012
Troubleshooting
36
10
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.
Case Closed
October 02, 2012
Agent-in Place
36
10
Only the strong survive when it comes to pharmaceutical packaging and shipping.
Obtaining Stable Homogenous Mixtures with Micronized APIs
October 02, 2012
Peer-Reviewed Research
36
10
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.
Q&A with James Ingebrand, 3M Drug Delivery Systems Division
October 02, 2012
Industry Leaders
36
10
A Q&A with James Ingebrand, Vice President and General Manager of 3M Drug Delivery Systems Division, on recent industry trends.
Seeking Solutions in Solid-State Chemistry
October 02, 2012
Pharma Ingredients
36
10
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.
In the Spotlight October 2012
October 02, 2012
In the Spotlight
36
10
New product reviews for October 2012, featuring analytical equipment.
Shifts in Pharma Capital Agendas
October 02, 2012
BioForum
36
10
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.
Applying Quality by Design for Extended Release Hydrophilic Matrix Tablets
October 02, 2012
Special Features
36
10
This study examines the effect and interaction of variations in hypromellose physicochemical properties.
Partnerships Remain Crucial to Future Development
October 02, 2012
Guest Editorial
36
10
Working together affords many unseen opportunities for pharmaceutical innovation.
Combination Drugs: Adding Up the Opportunities
October 02, 2012
Special Report
36
10
Fixed-dose combination drug therapies give rise to innovation in solid-dosage formulations and manufacturing.
New Era for Generic Drugs
October 02, 2012
Regulatory Watch
36
10
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.
FDA and the Importance of Confidentiality
October 02, 2012
Viewpoint
36
10
Recent news stories have reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.
Sizing the Market for Contract Manufacturing
October 02, 2012
Outsourcing Outlook
36
10
Measuring the size of the market for contract manufacturing services requires a careful hand.
Regulation and Compliance Q&A on 483s
October 02, 2012
In the Field
36
10
Q&A with David Elder and Richard Wright of Strategic Compliance Consulting, PAREXEL International. Both Elder and Wright formerly served with FDA.