Pharmaceutical Technology-09-02-2007

Pharmaceutical Technology
Articles

September 02, 2007

Researchers forward approaches for catalytic hydroformylation, asymmetric hydrogenation, and biocatalysis to achieve enantioselectivity.

Pharmaceutical Technology
Viewpoint

September 02, 2007

FDA must increase inspections of foreign API manufacturing facilities as more production moves offshore.

Pharmaceutical Technology
Outsourcing

September 02, 2007

Contract manufacturers slim down to improve profitability.

Online Exclusives
Pharmaceutical Technology

September 02, 2007

Appendix: definitions and regulations, Federal Food, Drug, and Cosmetic Act; Appendix: definitions and regulations, Title 21 Code of Federal Regulations; Appendix: definitions and regulations, Compliance Policy Guides

Pharmaceutical Technology
Online Exclusives

September 02, 2007

A comprehensive book helps readers navigate the European drug-approval process.

Pharma Capsules
Pharmaceutical Technology

September 02, 2007

News and Views

Pharmaceutical Technology
Packaging Forum

September 02, 2007

Going digital can produce high-quality, full-color labels at potentially lower cost.

Pharmaceutical Technology
Washington Report

September 02, 2007

User-fee legislation will require more testing and data disclosure to prevent unsafe drug use.

The influence of magnesium stearate (MgSt) on powder lubrication and finished solid-dose properties presents big challenges to drug manufacturers.

Pharmaceutical Technology
Online Exclusives

September 02, 2007

Jason Kamm, managing consultant with Tunnell Consulting discusses the challenges and opportunities for pharmaceutical manufacturers in ICH Q10, the draft guidance on pharmaceutical quality systems issued by the International Conference on Harmonization.

Pharmaceutical Technology
Articles

September 02, 2007

Articles
Pharmaceutical Technology

September 02, 2007

How the Indian pharmaceutical sector is reinventing itself

Pharmaceutical Technology

The draft guidance ICH Q10 for pharmaceutical quality systems is part of the ongoing move to a science- and risk-based approach in manufacturing.

In a nation of more than 1 billion people, the importance of vaccines goes beyond healthcare-it is a matter of national security. Armed with this belief and a philanthropic vision that most Indians could be protected against hepatitis, DT–Polio, and other afflictions, Dr. Varaprasad Reddy entered the nascent Indian biotechnology sector in 1992 and has since managed to threaten the monopoly of large laboratories. That year, the Hepatitis B vaccine cost $33 per shot, and yet some families were subsisting on less than $1 a day. Meanwhile, India was importing only 180,000 doses per year.

Articles
Pharmaceutical Technology

September 02, 2007

Useful Contacts

Pharmaceutical Technology
Agent-In-Place

September 02, 2007

Poor processing and misguided projections lead to trashed product.

Pharmaceutical Technology
In the Spotlight

September 02, 2007

Robust module facilitates filter changes; Rupture disks provide high-volume flow; Auger feeder avoids cross contamination

Pharmaceutical Technology
From The Editor

September 02, 2007

In an age of "pre-existing conditions," can a new bill help patients get the treatment they need?

This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.

Pharmaceutical Technology
This Time Around

September 02, 2007

When it comes to research, the United States scientific community is still way ahead of the game, but we're not sharing our findings as often as we should. According to a new National Science Foundation (NSF) report, the number of science and engineering articles by US-based authors published in major peer-reviewed journals has plateaued.

Pharmaceutical Technology
In the Field

September 02, 2007

US and China Crack Down on Regulation after SFDA Chief Executed; Xcellerex Receives US Grant for Biopharmaceutical Production; New FDA Guidance on Polymorphic Compounds in Generic Drugs; Comment Periods Open for ICH Q10 and Biologics Guidelines

Larger and strategic sampling and testing plans can improve process understanding and characterization.