Pharmaceutical Technology, Oct 2, 2014 - Pharmaceutical Technology

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Pharmaceutical Technology, Oct 2, 2014
Cover Story
Solving Poor Solubility with Amorphous Solid Dispersions
By Adeline Siew, PhD
Weighing the pros and cons of hot-melt extrusion and spray drying.
Special Report
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach
By Hafez Abdel-Kader , Mark Argentine , Jeff Hofer , Nancy Benz , Rick Burdick , Marion Chatfield , Frank Diana , Hui Fang , Yuan Huang , Shreekant Karmarkar , Lakshmy M. Nair , Theresa Natishan , Andrea M. Pless , Qinggang Wang , Zeena Williams
A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
Formulation
New Technologies Enhance the Formulation of Highly Potent Drugs
By Cynthia Challener, PhD
Advances in solid and liquid formulation techniques are providing more options.
Peer Reviewed
The Role of Normal Data Distribution in Pharmaceutical Development and Manufacturing
By Lori B. Pfahler , Kim Erland Vukovinsky
Review challenges in the use of normality testing situations and recommendations on how to assess data distributions in the pharmaceutical development manufacturing environment
Using the Guard Band to Determine a Risk-Based Specification
By Chris Burgess
A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.
Featured Content
Marrying Big Data with Personalized Medicine
Data analytic strategies can help companies capitalize on personalized medicine.
Regulatory Watch
Biopharma Manufacturers Respond to Ebola Crisis
By Jill Wechsler
Demand for new therapies and vaccines spotlights production challenges.
Harmonizing Marketing Approval of Generic Drugs in Europe
By Sean Milmo
Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.
API Synthesis & Manufacturing
Fluorination Remains Key Challenge in API Synthesis
By Cynthia Challener, PhD
Safer fluorinating reagents and access to GMP fluorination capabilities remain challenges in API synthesis.
Outsourcing Outlook
CMO Industry Thins Out
By Jim Miller
The trend of exits from the CMO industry looks to be gaining momentum.
Global Feature
Economic Growth Stalls in Brazil
By Hellen Berger
Brazil's pharmaceutical industry is optimistic, but is the pharmaceutical market growing steadily or showing signs of instability?
Troubleshooting
Determining Facility Mold Infection
By Jim E. Akers , John M. Lindsay
The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.
Guest Editorial
Bolstering Graduate Education and Research Programs
By Marilyn E. Morris
AAPS supports graduate-level programs impacted by cutbacks in funding and resources.
Packaging Forum
Packaging Addresses Cold-Chain Requirements
By Hallie Forcinio
Temperature-controlled packaging trends include prequalified systems that simplify adoption, reusable systems that are more sustainable, and new temperature-monitoring technology.
Ask the Expert
Automation: A Cure-All?
By Siegfried Schmitt
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses the benefits of automated processes.
Product Spotlight
Fette Tablet Press Designed for High Production
Fette Compacting America FE75 Tablet Press is designed to produce up to 1.6 million tablets per hour.
GEA Pharma Systems Valves Contain Powders
GEA Pharma Systems' Buck MC valves are designed to address powder-handling needs for solid dosage form production.
Romaco Kilian's Tablet Press Introduces Continuous Weight Control
Romaco Kilian's KTP 420X tablet press compresses up to 360,000 tablets an hour.
Ross Agitated Vessel Includes Silicone Heating Blankets
The Ross VSL-50 is a portable 50-gallon agitated vessel with silicone heating blankets and temperature sensors fabricated in stainless steel 316 and designed for atmospheric operation.
Packaging
Visual and Automated Inspection Technologies for Glass Syringes
By Bernhard Hinsch, PhD
To achieve the high quality standards required for critical defects in pharmaceutical glass syringes, a combination of visual and camera-based inspection technologies are used.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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