A Perspective from FDA on ICH Q10 Pharmaceutical Quality System for Contract Manufacturers
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
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
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
To move from R&D to breakthrough drugs, biotech companies need policies that support innovation.
Pharma Faces Multiple Challenges in the Year Ahead
Globalization and reform initiatves will shape pharma production, pricing, and pipelines in 2010.
A Look Ahead for 2010
Some predictions for contract services in 2010.
In the Field: Report from Brazil
Is Brazil's pharmaceutical industry following the consolidation trend?
GSK Gets under Your Skin
A recent deal could chart new paths in drug delivery and in the administration of vaccines.
Tracking API Growth
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?
When to use percent relative standard deviation-and how to do so correctly.
In the Spotlight January 2010
Editors' Picks of Pharmaceutical Science & Technology Innovations
A Mass Transfer of Knowledge
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
Team leaders in FDA's Office of Generic Drugs provide an overview.
AAI Pharma's Lee Karras talks about contract-service demand.
Plus, novel dosage forms and emerging trends.
A PAT Solution for Automated Mill Control
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
From healthcare to corruption to life expectancy, here's what we can learn from the past decade.
Personnel Problems
Directors and staff miss the mark when it comes to following procedures.
Pharmaceutical Technology North America, January 2010 (PDF)
Quality by Design, Deficiencies in Generic Drug Applications, API Growth, Topical Berberine-Hydrochloride Products
