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Pharmaceutical Technology-01-02-2010
Pharmaceutical Technology
A Perspective from FDA on ICH Q10 Pharmaceutical Quality System for Contract Manufacturers
January 02, 2010
Online Exclusives
34
1
Grace McNally, in the Office of Compliance at FDA's CDER, discusses the role of QbD and pharmaceutical quality systems as it relates to contract manufacturing.
Understanding Biological Indicator Grow-Out Times
January 02, 2010
Online Exclusives
34
1
This study used biological indicators containing Geobacillus stearothermophilus spores and a new technology to continuously monitor incubated BIs and record nonsterile results.
The Formulation and Evaluation of Topical Berberine-Hydrochloride Products
January 02, 2010
Peer-Reviewed Research
34
1
The authors sought to prepare a topical formulation of berberine hydrochloride for the effective and controlled management of inflammation and skin infections.
Healthcare Reform Requires Room for Innovation
January 02, 2010
Viewpoint
34
1
To move from R&D to breakthrough drugs, biotech companies need policies that support innovation.
Pharma Faces Multiple Challenges in the Year Ahead
January 02, 2010
Washington Report
34
1
Globalization and reform initiatves will shape pharma production, pricing, and pipelines in 2010.
A Look Ahead for 2010
January 02, 2010
Outsourcing Outlook
34
1
Some predictions for contract services in 2010.
In the Field: Report from Brazil
January 02, 2010
News
34
1
Is Brazil's pharmaceutical industry following the consolidation trend?
GSK Gets under Your Skin
January 02, 2010
PharmTech Talk
34
1
A recent deal could chart new paths in drug delivery and in the administration of vaccines.
Tracking API Growth
January 02, 2010
Ingredients Insider
34
1
Growth in emerging markets and across the generic-drug sector shifts the global demand and supply of active pharmaceutical ingredients.
Statistical Solutions: %RSD: Friend or Foe?
January 02, 2010
Statistical Solutions
34
1
When to use percent relative standard deviation-and how to do so correctly.
In the Spotlight January 2010
January 02, 2010
In the Spotlight
34
1
Editors' Picks of Pharmaceutical Science & Technology Innovations
A Mass Transfer of Knowledge
January 02, 2010
Online Exclusives
34
1
A comprehensive book about mass transfer benefits from the author's personal touch.
FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 1: Drug Substance
January 02, 2010
Special Report
34
1
Team leaders in FDA's Office of Generic Drugs provide an overview.
AAI Pharma's Lee Karras talks about contract-service demand.
January 02, 2010
Industry Leaders: Q&A
34
1
Plus, novel dosage forms and emerging trends.
A PAT Solution for Automated Mill Control
January 02, 2010
Online Exclusives
34
1
The authors describe the implementation of an on-line particle-size analyzer on an active pharmaceutical ingredient milling operation at a commercial site.
Refocusing Our Resources
January 02, 2010
From The Editor
34
1
From healthcare to corruption to life expectancy, here's what we can learn from the past decade.
Personnel Problems
January 02, 2010
Agent-in Place
34
1
Directors and staff miss the mark when it comes to following procedures.
Pharmaceutical Technology North America, January 2010 (PDF)
January 02, 2010
Issue PDF
34
1
Quality by Design, Deficiencies in Generic Drug Applications, API Growth, Topical Berberine-Hydrochloride Products