Freeze-Drying Process Optimization for a Small Molecule
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
Peptides and related technologies to are starting to improve production.
Regulation and Compliance Q&A: Change Management
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
When designing stability protocols, formulation, storage, and dosing conditions must be assessed.
In the Spotlight June 2012
New product reviews for June 2012.
GMPs for Small-Molecule Drugs in Early Development (Part I)
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
Looking for Fingerprints: Bioanalytical Characterization of Biosimilars
Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.
Biomanufacturing Innovation
Industry wants more innovation, but can suppliers meet customer needs?
Q&A with Larry Kadis, Federal Equipment
A Q&A with Larry Kadis, President and CEO of Federal Equipment, on recent industry trends.
New Packaging Technologies Displayed at INTERPHEX
Highlights included the latest in pharmaceutical packaging equipment, containers, and labels and new capabilities among contract service providers.
Back-to-Basics with PDUFA V
BIO is calling for a more patient-centric approach to user-fee reauthorization.
Avoiding Contamination Risks in Aseptic Processes
How to avoid invisible and airborne contamination.
Inside USP: US Pharmacopeia Proposes New Standard on Glass Quality
US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.
Report from India
New price-control policy has domestic and global firms waiting on the sidelines to launch products.
Innovation Boom Towns
Partnerships between industry and academic medical centers are expanding to meet R&D needs.
Advanced Tablet-Coating Technologies Aid Manufacturing Efficiency
New coating technologies achieve high uniformity and reduce waste through mixing system advances and pan and airflow configuration.
Cheap versus Expensive
UK chooses to use off-label drug indication to cut healthcare costs. Will others follow suit?
Manufacturers Back Innovation Initiatives
New legislation, government programs aim to bolster drug discovery and reduce regulatory hurdles.
Biosimilar Developers Face a Reference-Product Dilemma
Does global development have to entail multiple comparability studies?
A "Big E" on the Scoreboard
Even the slightest of errors in exponential calculations can cause the biggest of headaches.
Pharmaceutical Technology, June 2012 Issue (PDF)
Looking For Fingerprints
