Pharmaceutical Technology, Mar 2, 2009 - Pharmaceutical Technology

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Pharmaceutical Technology, Mar 2, 2009
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No Excuse for Nonconformance
By Roger Dabbah
An updated book provides essential information for scientists who monitor microbial quality.
Special Report
Targeting Spending and Innovation Levels: Annual Equipment and Machinery Survey
By Patricia Van Arnum
Pharmaceutical Technology's annual survey on equipment and machinery shows fewer companies increased spending in 2008 and still fewer will increase spending in 2009 as overall economic conditions affects purchasing decisions.
Is JIT Manufacturing the Right Prescription?
By Erik Greb
Small- and large-molecule drugmakers debate whether they can replicate other industries' success with just-in-time manufacturing.
Peer-Reviewed Research
Formulation Effects on the Thermomechanical Properties and Permeability of Free Films and Coating Films: Characterization of Cellulose Acetate Films
By Jinghua Yuan , Doug Dunn , Nancy M. Clipse , Ray J. Newton, Jr.
The authors investigate the effects of a polyethylene glycol plasticizer and water on cellulose acetate film properties.
Ruggedness of Visible Residue Limits for Cleaning Validation
By Richard J. Forsyth
The author tests the ruggedness of VRL viewing conditions and defines optimal viewing conditions.
Ultra High Performance Liquid Chromatography in the Contract Manufacturing Environment
By Allison A. Aldridge , Roger Halbert , Peter Groenewoud
Ultra high performance liquid chromatography is advantageous in a contract laboratory because it is faster, more sensitive, and relies on smaller volumes of organic solvents than HPLC.
Extending Calibrations for Near Infrared Assay of Tablets Using Synthetic Modeling and Variance from Placebos
By Robert Mattes , Denise Root
The authors extend the range of a near-infrared calibration model for tablet assay using production 'seed' spectra and synthetic spectra generated from placebos and 'pure' active pharmaceutical ingredient spectra.
Modeling Pharmaceutical Powder-Flow Performance Using Particle-Size Distribution Data
By Matthew P. Mullarney , Norma Leyva
The authors present a simple and material-sparing approach for estimating the powder-flow performance of previously uncharacterized single-component bulk powders when only particle-size distribution data are available.
Ingredients Insider
Narrowing the Geographic Divide in API Sourcing
By Patricia Van Arnum
Contract manufacturers deploy a business model using operations in the US and Western Europe with facilities in Asia.
Online Exclusives
New Leadership and More Resources Aim to Modernize FDA Operations
By Jill Wechsler
Instead of protecting the public from unsafe drugs and contaminated foods, the Food and Drug Administration is a "hazard to public health," stated President Barack Obama in announcing his choices to head the agency and new efforts to improve food safety. Margaret Hamburg will be FDA's new commissioner, and Joshua Sharfstein principal deputy commissioner for drugs and medical products.
Outsourcing Outlook
The New Normal: The Changing Face of Pharma
By Jim Miller
When the business environment returns to "normal," our industry may appear quite different.
Washington Report
A Call for Transparency in Research and Marketing
By Jill Wechsler
Broader disclosure of drug prices and conflicts of interest are central healthcare reform issues.
Inside USP
Inside USP: Heparin Monographs Further Revised
By Anita Y. Szajek , Tina S. Morris , William F. Koch , Darrell R. Abernethy , Roger L. Williams
USP's Stage 2 heparin monograph revisions address identification, potency, and impurities.
Agent-In-Place
Detective Work
By Control, a senior compliance officer
The source of a problem reveals itself after some investigation, or it may crash down on you.
Packaging Forum
End-to-End Innovations
By Hallie Forcinio
Integrated lines, flexible machines, and high-barrier materials enhance packaging options.
Guest Editorial
Critical Challenges Require Core Values
By RJ Palermo
Industry has changed, but its basic tenets have not. INTERPHEX's RJ Palermo discusses a 7-step process to keep pharma moving forward.
Viewpoint
Changes to Vial Labels May Affect Patient Safety
By Frederick J. Balboni, Jr.
USP's revised chapter on injectables could harm anticounterfeiting efforts and drug administration.
PharmTech Talk
API Outsourcing is Mixed
By Patricia Van Arnum
Contract manufacturers of APIs and intermediates report gains, but express caution.
News
Report From: India
By A. Nair
With the economy down and multinational firms capitalizing on patents in developing countries, India's R&D sector still has a long way to grow.
Coming Down the Pike: Treating Epilepsy
By Michelle Hoffman
Scientists studying epilepsy have traditionally focused on the comings and goings of ions through molecular channels in nerve cells, and many current antiseizure therapies seek to modulate that dynamic.
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for March 2009.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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