Pharmaceutical Technology, Aug 2, 2010 - Pharmaceutical Technology

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Pharmaceutical Technology, Aug 2, 2010
Online Exclusives
Adopting Serialization
By Hallie Forcinio
Serialized product codes serve as the foundation of ePedigree records and product traceability.
Bioburden Method Suitability for Cleaning and Sanitation Monitoring: How Far Do We Have to Go?
By Angel L. Salaman-Byron
The author reviews test methods for microbiological cleaning processes and suggests ways to improve microbial bioburden method suitability studies.
A Commendable Cleanroom Compendium
By James E. Akers
The updated edition of William Whyte's book provides information for novices and seasoned professionals alike.
Special Report
Big Pharma's Manufacturing Strategy: What is the Next Move?
By Patricia Van Arnum
Pharmaceutical Technology's annual analysis of the pharmaceutical majors' activities shows a shrinking global manufacturing network amidst company restructuring, product intensification in biologics, and a strategic focus and push to emerging markets.
Developing siRNA Therapies: A Technical Forum
By Alexis Pellek
Pharmaceutical Technology talked to experts in siRNA-drug development to gain insight into the characteristics, processes, and challenges of this class of therapeutics.
FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 2: Description, Composition, and Excipients
By Aloka Srinivasan , Robert Iser , Devinder S. Gill
FDA chemistry reviewers in the Office of Generic Drugs provide an overview of common deficiences cited throughout the Chemistry, Manufacturing, and Controls section of ANDAs.
Peer-Reviewed
Statistical Considerations in Design Space Development (Part II of III)
By Stan Altan , James Bergum , Lori Pfahler , Edith Senderak , Shanthi Sethuraman , Kim Erland Vukovinsky
The authors discuss the statistical tools used in experimental planning and stategy and how to evaluate the resulting design space and its graphical representation.
Engineering Processing Properties of Acetaminophen by Cosolvent Screening
By Tu Lee , Gen Da Chang
The authors used common solvents to develop an initial solvent-screening method for laboratory-scale research to determine the solubility, polymorphism, and crystal properties of various active ingredients.
Ingredients Insider
Exploring Chiral Chemistry
By Patricia Van Arnum
Chemocatalytic and biocatalytic approaches in asymmetric synthesis help provide a pathway for producing single-enantiomer drugs.
Green Drug Delivery: Spray-dried solid amorphous dispersions with a cellulosic exicpient
By Patricia Van Arnum
Green chemistry in pharmaceutical development often centers around approaches in the synthesis of the active ingredient, but green-chemistry techniques also can be applied to drug-product manufacturing, formulation development, and drug delivery.
From The Editor
An Ounce of Prevention
By Michelle Hoffman
Industry's focus on cost cutting has led to a dangerous gap in training and knowledge.
Insider Solutions
Insider Solutions: The Quality Agreement
By Susan J. Schniepp
Before embarking on an outsourcing relationship, it's important to be aware of FDA's expectations.
Industry Leaders
Q&A with Jerry Jost
The president of Jost Chemical talks about client demands, supplier audits, and more.
PharmTech Talk
FDA Mulls More Obesity Drugs
By Alexis Pellek
Three therapies under review could help Americans attain a healthy weight.
Agent-in Place
Turning a Blind Eye
By Control, a senior compliance officer
Cases of overlooking proper packaging, reconstitution, directions, and dissolution.
In the Spotlight
In the Spotlight
Editors' picks of pharmaceutical science and technology innovations.
News
Report from Asia
By Jane Wan
Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.
Washington Report
Manufacturing Failures Place GMP Compliance in Spotlight
By Jill Wechsler
Fallout escalates from McNeil recall and Genzyme shortages as regulators review oversight.
Outsourcing Outlook
Project Managers Wanted
By Eric Langer
Relationship management is a limiting factor to growth in biomanufacturing outsourcing.
Viewpoint
Catalyst for Change
By Chris Strutt
Industry can meet its responsibility to society by considering innovative pricing and partnerships.

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Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
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