Pharmaceutical Technology, Aug 2, 2013 - Pharmaceutical Technology

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Pharmaceutical Technology, Aug 2, 2013
Cover Story
Evaluating the Pieces in Big Pharma's Manufacturing Investments
By Patricia Van Arnum
The pharmaceutical majors target biologics and emerging markets in their manufacturing expansion activities and plans.
Solutions in Pharmaceutics
Demonstrating Biosimilarity
By Alison Armstrong
Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.
Global Feature
Report from India
By Jane Wan
Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.
Report from South Korea
By Jill E. Sackman
The bio-pharmaceutical business outlook in South Korea remains positive.
Regulation & Compliance
Generic Drugs Face Regulatory and Scientific Challenges
By Jill Wechsler
FDA funds research to further development of innovative generics, while working to address review and approval issues.
Regulatory Roundup
By Jill Wechsler
Appropriate use of medications promises to improve patient care and curb spending, prompting pharmacists, public health authorities, and manufacturers to promote multiple adherence strategies.
Seeking Harmonization in Nanomedicines Regulatory Framework
By Sean Milmo
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
API Synthesis & Manufacturing
Advancing Peptide Synthesis Through Stapled Peptides
By Patricia Van Arnum
Stapled peptides offer promise to enable cell permeability, binding to therapeutic targets, and modulation of biological pathways.
Peer-Reviewed Research
Alternative Solvents for Extractables and Leachables Evaluation
By Jennifer M. Roark , Mai N. Jacques , Erica J. Tullo , Andrew T. Blakinger , Thomas C. Lehman
The authors examine alternative solvents for extractables and leachables screening evaluation of process components that provide extraction equivalence and do not interfere chromatographically.
Troubleshooting
Using Tandem LC-MS for Cleaning Validation
By Geoff Carr
The author describes how liquid chromatography-mass spectrometry works and explains some of its advantages and disadvantages, particularly compared to high-performance liquid chromatography.
BioForum
New Gene Patent Rules
By Antoinette Konski
The US Supreme Court's Myriad decision satisfied both patient groups and patent holders
Outsourcing Outlook
Bioprocessing Advances in Vaccine Manufacture
By Eric Langer , Ronald Rader
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
From The Editor
Filling a Gap in Drug Safety
By Rita Peters
As the Supreme Court ruled on generic-drug liability, FDA outlined new rules for warning labels.
Ask the Expert
Regulatory Inspections Get Serious
Siegfried Schmitt of PAREXEL explains how regulatory agencies are getting serious about inspections.
In the Spotlight
Product Spotlight: Analytical Instrumentation
Editor's Pick's of Pharmaceutical Science & Technology Innovations: The latest in analytical instrumentation including mass spectrometers, calorimeters, and viscometers.

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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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