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Pharmaceutical Technology-08-02-2010
Pharmaceutical Technology
A Commendable Cleanroom Compendium
August 02, 2010
Online Exclusives
34
8
The updated edition of William Whyte's book provides information for novices and seasoned professionals alike.
Bioburden Method Suitability for Cleaning and Sanitation Monitoring: How Far Do We Have to Go?
August 02, 2010
Online Exclusives
34
8
The author reviews test methods for microbiological cleaning processes and suggests ways to improve microbial bioburden method suitability studies.
Adopting Serialization
August 02, 2010
Online Exclusives
34
8
Serialized product codes serve as the foundation of ePedigree records and product traceability.
Manufacturing Failures Place GMP Compliance in Spotlight
August 02, 2010
Washington Report
34
8
Fallout escalates from McNeil recall and Genzyme shortages as regulators review oversight.
An Ounce of Prevention
August 02, 2010
From The Editor
34
8
Industry's focus on cost cutting has led to a dangerous gap in training and knowledge.
Statistical Considerations in Design Space Development (Part II of III)
August 02, 2010
Peer-Reviewed
34
8
The authors discuss the statistical tools used in experimental planning and stategy and how to evaluate the resulting design space and its graphical representation.
Turning a Blind Eye
August 02, 2010
Agent-in Place
34
8
Cases of overlooking proper packaging, reconstitution, directions, and dissolution.
FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 2: Description, Composition, and Excipients
August 02, 2010
Special Report
34
8
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.
Report from Asia
August 02, 2010
News
34
8
Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.
Q&A with Jerry Jost
August 02, 2010
Industry Leaders
34
8
The president of Jost Chemical talks about client demands, supplier audits, and more.
Catalyst for Change
August 02, 2010
Viewpoint
34
8
Industry can meet its responsibility to society by considering innovative pricing and partnerships.
Big Pharma's Manufacturing Strategy: What is the Next Move?
August 02, 2010
Special Report
34
8
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.
Engineering Processing Properties of Acetaminophen by Cosolvent Screening
August 02, 2010
Peer-Reviewed
34
8
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.
Project Managers Wanted
August 02, 2010
Outsourcing Outlook
34
8
Relationship management is a limiting factor to growth in biomanufacturing outsourcing.
In the Spotlight August 2010
August 02, 2010
In the Spotlight
34
8
Editors' picks of pharmaceutical science and technology innovations.
Developing siRNA Therapies: A Technical Forum
August 02, 2010
Special Report
34
8
Pharmaceutical Technology talked to experts in siRNA-drug development to gain insight into the characteristics, processes, and challenges of this class of therapeutics.
Exploring Chiral Chemistry
August 02, 2010
Ingredients Insider
34
8
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
August 02, 2010
Ingredients Insider
34
8
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.
FDA Mulls More Obesity Drugs
August 02, 2010
PharmTech Talk
34
8
Three therapies under review could help Americans attain a healthy weight.
Insider Solutions: The Quality Agreement
August 02, 2010
Insider Solutions
34
8
Before embarking on an outsourcing relationship, it's important to be aware of FDA's expectations.
Pharmaceutical Technology, August 2010 Issue (PDF)
August 01, 2010
Issue PDF
34
8
Big Pharma?s Manufacturing Strategy: What is the Next Move?