Pharmaceutical Technology
July 18, 2012
Online Exclusives
36
7
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.
July 02, 2012
Issue PDF
36
7
Celebrating Pharma Innovation
July 02, 2012
BioForum
36
7
Holistic open learning networks offer a new drug R&D model for improving research outcomes.
July 02, 2012
Special Features
36
7
How FDA, USP, and ICH have redirected industry practice.
July 02, 2012
Special Features
36
7
Jim Miller, president of PharmSource, examines the future direction of CROs/CMOs and the factors influencing the pharmaceutical contract services sectors.
July 02, 2012
Outsourcing Outlook
36
7
The past three decades have driven a purchasing evolution to a procurement revolution.
July 02, 2012
Troubleshooting
36
7
Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.
July 02, 2012
Special Features
36
7
Industry experts share their insight on solid-dosage and sterile manufacturing.
July 02, 2012
Special Features
36
7
Tracking changes from spinoffs of chemical companies to life-sciences powerhouses.
July 02, 2012
In the Field
36
7
EMA and MHRA provide insight into increased GMP deficiencies.
July 02, 2012
Position Paper
36
7
IQ Consortium representatives explore industry approaches for applying GMPs in early development.
July 02, 2012
In the Field
36
7
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.
July 02, 2012
Agent-in Place
36
7
Careful attention to detail will help to prevent valuable assets from "melting" away.
July 02, 2012
Industry Leaders
36
7
A Q&A with Thomas E. D'Ambra, Chairman, CEO, & President of AMRI, on recent industry trends.
July 02, 2012
From The Editor
36
7
Taking time to appreciate the industry's greatest achievements will inspire growth ahead.
July 02, 2012
Special Features
36
7
Readers point to quality by design as having a significant influence on manufacturing and drug development during the past decade.
July 02, 2012
Pharma Ingredients
36
7
Companies roll out expansions in manufacturing high-potency APIs and finished products.
July 02, 2012
Regulatory Watch
36
7
A Q&A with FDA Deputy Commissioner Deborah Autor.
July 02, 2012
Special Features
36
7
Sponsor companies' increasing focus on strategic outsourcing has changed the rules of the game.
July 02, 2012
PharmTech Talk
36
7
Developments in hot-melt extrusion using twin-screw extruders to make solid-dosage drug forms.
July 02, 2012
Online Exclusives
36
7
Advances in targeted drug delivery and customized release profiles are key goals.
July 02, 2012
Special Features
36
7
An industry roundtable on how users and makers can best assess and manage black specks.
July 02, 2012
Special Features
36
7
Improvements in expression platforms and enhanced tools for selecting clones are among the advances of the past few decades.
July 02, 2012
Statistical Solutions
36
7
Applying current principals to traditional factorial designs.
July 02, 2012
Special Features
36
7
Flow chemistry and microreactors offer alternatives to traditional batch manufacturing.
July 02, 2012
Statistical Solutions
36
7
Uniform dose formulation is key to meeting safety study requirements.
July 02, 2012
Special Features
36
7
A look back at key nanoformulation advances and what lies ahead for nanoparticle-based drug-delivery systems.
July 02, 2012
Online Exclusives
36
7
Gold nanoparticles for targeting tumor sites and elastic capsules using nanosized flakes are some recent approaches used to control and target drug delivery.
July 02, 2012
Online Exclusives
36
7
Industry experts share perspectives on analytical instrumentation, methods, and data analysis.
July 02, 2012
Viewpoint
36
7
Presidents of leading associations offer views on the industry's future.