Pharmaceutical Technology, Jul 2, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, Jul 2, 2012
Online Exclusives
35th Anniversary Special: The Today and Tomorrow of Process Analytical Technology
By Patricia Van Arnum
Industry experts share perspectives on analytical instrumentation, methods, and data analysis.
35th Anniversary Special: Future Innovation in Drug Delivery
By Patricia Van Arnum
Advances in targeted drug delivery and customized release profiles are key goals.
Requirements for Electronic Records Contained in 21 CFR 211
By Orlando López
The author discusses the regulatory requirements for electronic records contained in Title 21 CFR Part 211 and how they overlap with the requirements set forth in Title 21 CFR Part 11.
Formulation Development Forum: Nanotechnology-based Drug Delivery
By Patricia Van Arnum
Gold nanoparticles for targeting tumor sites and elastic capsules using nanosized flakes are some recent approaches used to control and target drug delivery.
Special Features
Atypical Visible Particles
By Angie Drakulich
An industry roundtable on how users and makers can best assess and manage black specks.
35th Anniversary Special: Breakthroughs and Emerging Technologies in Manufacturing
By Jennifer Markarian
Industry experts share their insight on solid-dosage and sterile manufacturing.
35th Anniversary Special: The Transformation of Regulation and Global Standards
By Susan J. Schniepp
How FDA, USP, and ICH have redirected industry practice.
35th Anniversary Special: What's Ahead in Chemical API Manufacturing
By Patricia Van Arnum
Flow chemistry and microreactors offer alternatives to traditional batch manufacturing.
35th Anniversary Special: Advances in Protein Expression
By Amy Ritter
Improvements in expression platforms and enhanced tools for selecting clones are among the advances of the past few decades.
35th Anniversary Special: Decades of Change for the Top Pharmaceutical Companies
By Patricia Van Arnum
Tracking changes from spinoffs of chemical companies to life-sciences powerhouses.
35th Anniversary Special: Reader Views on Changes in Pharmaceutical Manufacturing
By Patricia Van Arnum , Stephanie Sutton
Readers point to quality by design as having a significant influence on manufacturing and drug development during the past decade.
35th Anniversary Special: New Models in Contract Services
By Patricia Van Arnum
Sponsor companies' increasing focus on strategic outsourcing has changed the rules of the game.
A Look into the Future of Pharmaceutical Outsourcing: Perspectives from Jim Miller, president of PharmSource
By Patricia Van Arnum
Jim Miller, president of PharmSource, examines the future direction of CROs/CMOs and the factors influencing the pharmaceutical contract services sectors.
35th Anniversary Special: Nanoformulations
By Amy Ritter
A look back at key nanoformulation advances and what lies ahead for nanoparticle-based drug-delivery systems.
Position Paper
GMPs for Method Validation in Early Development: An Industry Perspective (Part II)
By Donald Chambers , Gary Guo , Brent Kleintop , Henrik Rasmussen , Steve Deegan , Steven Nowak , Kristin Patterson , John Spicuzza , Michael Szulc , Karla Tombaugh , Mark D. Trone , Zhanna Yuabova
IQ Consortium representatives explore industry approaches for applying GMPs in early development.
Troubleshooting
Lyophilization: How to Meet Scale-Up Challenges Using QbD
By Stephanie Sutton
Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.
From The Editor
Pharmaceutical Technology: 35 Years and Going Strong
By Angie Drakulich
Taking time to appreciate the industry's greatest achievements will inspire growth ahead.
In the Field
Report from Europe
By Sean Milmo
EMA and MHRA provide insight into increased GMP deficiencies.
Regulation and Compliance Q&A: Preparing for Inspections
Q&A with David Elder of Strategic Compliance Consulting, PAREXEL International on preparing for the rise in inspections. Elder is a former senior official with FDA.
PharmTech Talk
Hot-Melt Developments
By Jennifer Markarian
Developments in hot-melt extrusion using twin-screw extruders to make solid-dosage drug forms.
Agent-in Place
A Lukewarm Reception
By Control, a senior compliance officer
Careful attention to detail will help to prevent valuable assets from "melting" away.
Regulatory Watch
FDA Adopts New Strategies to Oversee Global Economy
By Jill Wechsler
A Q&A with FDA Deputy Commissioner Deborah Autor.
In the Spotlight
In the Spotlight
New product reviews for July 2012.
BioForum
A New R&D Paradigm
By Gautam Jaggi
Holistic open learning networks offer a new drug R&D model for improving research outcomes.
Statistical Solutions
Placket–Burman Designs
By Lynn D. Torbeck
Applying current principals to traditional factorial designs.
How to Assess Preclinical Dose Formulation Homogeneity
By Amy Smith , Melissa Whitsel
Uniform dose formulation is key to meeting safety study requirements.
Pharma Ingredients
High-Potency Manufacturing Remains Strong
By Patricia Van Arnum
Companies roll out expansions in manufacturing high-potency APIs and finished products.
Outsourcing Outlook
Reflecting on 35 Years of Procurement Transformation
By Gregg Brandyberry
The past three decades have driven a purchasing evolution to a procurement revolution.
Industry Leaders
Q&A with Thomas E. D'Ambra, AMRI
A Q&A with Thomas E. D'Ambra, Chairman, CEO, & President of AMRI, on recent industry trends.
Viewpoint
Future Innovation
Presidents of leading associations offer views on the industry's future.

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Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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