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Pharmaceutical Technology-06-02-2012
Pharmaceutical Technology
Freeze-Drying Process Optimization for a Small Molecule
June 02, 2012
Peer-Reviewed Research
36
6
The authors evaluate the thermal properties of gentamicin sulfate as a small-molecule drug model in optimizing the freeze-drying cycle.
Peptides Gain Traction in Drug Development
June 02, 2012
Pharma Ingredients
36
6
Peptides and related technologies to are starting to improve production.
Regulation and Compliance Q&A: Change Management
June 02, 2012
In the Field
36
6
Q&A with Peter Smith, Strategic Compliance Consulting, PAREXEL International, and a former senior official with FDA, on change management best practices.
Preclinical Dose-Formulation Stability
June 02, 2012
Special Features
36
6
When designing stability protocols, formulation, storage, and dosing conditions must be assessed.
GMPs for Small-Molecule Drugs in Early Development (Part I)
June 02, 2012
Position Paper
36
6
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
Looking for Fingerprints: Bioanalytical Characterization of Biosimilars
June 02, 2012
Special Reports
36
6
Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.
Biomanufacturing Innovation
June 02, 2012
Outsourcing Outlook
36
6
Industry wants more innovation, but can suppliers meet customer needs?
Q&A with Larry Kadis, Federal Equipment
June 02, 2012
Industry Leaders
36
6
A Q&A with Larry Kadis, President and CEO of Federal Equipment, on recent industry trends.
New Packaging Technologies Displayed at INTERPHEX
June 02, 2012
Packaging Forum
36
6
Highlights included the latest in pharmaceutical packaging equipment, containers, and labels and new capabilities among contract service providers.
Back-to-Basics with PDUFA V
June 02, 2012
Guest Editorial
36
6
BIO is calling for a more patient-centric approach to user-fee reauthorization.
Avoiding Contamination Risks in Aseptic Processes
June 02, 2012
Special Features
36
6
How to avoid invisible and airborne contamination.
Inside USP: US Pharmacopeia Proposes New Standard on Glass Quality
June 02, 2012
Inside USP
36
6
US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.
Report from India
June 02, 2012
In the Field
36
6
New price-control policy has domestic and global firms waiting on the sidelines to launch products.
Innovation Boom Towns
June 02, 2012
BioForum
36
6
Partnerships between industry and academic medical centers are expanding to meet R&D needs.
Advanced Tablet-Coating Technologies Aid Manufacturing Efficiency
June 02, 2012
Troubleshooting
36
6
New coating technologies achieve high uniformity and reduce waste through mixing system advances and pan and airflow configuration.
Cheap versus Expensive
June 02, 2012
PharmTech Talk
36
6
UK chooses to use off-label drug indication to cut healthcare costs. Will others follow suit?
Manufacturers Back Innovation Initiatives
June 02, 2012
Regulatory Watch
36
6
New legislation, government programs aim to bolster drug discovery and reduce regulatory hurdles.
Biosimilar Developers Face a Reference-Product Dilemma
June 02, 2012
Viewpoint
36
6
Does global development have to entail multiple comparability studies?
A "Big E" on the Scoreboard
June 02, 2012
Agent-in Place
36
6
Even the slightest of errors in exponential calculations can cause the biggest of headaches.