Pharmaceutical Technology-08-02-2007

August 02, 2007

Feedback is urged on USP's proposed revisions to the General Notices.

August 02, 2007

FDA approvals renew the threat of competition from India and China.

August 02, 2007

FDA's long-awaited GMPs for supplements appear as food and drug safety concerns override lingering opposition.

August 02, 2007

By vetoing stem cell research funding, the President is vetoing potentially life-saving treatments.

August 02, 2007

Makers of temperature-sensitive products constantly seek to ensure proper conditions during shipping and storage.

August 02, 2007

The "Solo-VPE" device from C Technologies (Bridgewater, NJ) improves UV–vis measurements by matching the length of the light path to the sample. The unit's software lets users establish thresholds, and the machine adjusts the pathlength and wavelength accordingly. Mark Salerno, director of manufacturing at C Technologies, says the device "... works for you until it finds the measurement range you want it to be in." He adds that the unit expands the operational range of UV–vis instruments. It facilitates measurements from roughly 50 μm to more than 10 mm. Measurements can be adjusted in 10-μm increments.

August 02, 2007

Did you know that only one-third of prescribed pediatric drugs have been studied or labeled for pediatric use? The Best Pharmaceuticals for Children Act (BPCA) was enacted in 2002 to improve this statistic by providing companies with six months of additional marketing exclusivity if they conduct pediatric trials. The Government Accountability Office recently issued a report that examined data from studies conducted between 2002 and 2005 for drugs specified by the US Food and Drug Administration under BPCA.

August 02, 2007

A spate of drugs are scheduled to come off patent, offering vast potential and competition.

August 02, 2007

The book comprehensively reviews the basics of drug absorption and methods for delivery enhancement through various routes of administration.

August 02, 2007

The authors examine advances in the design and the application of biological indicator evaluator resistometer vessels used to measure the resistance of bacterial spores in monitoring sterilization processes.

August 02, 2007

Production sometimes follows the law of supply and reprimand.

August 02, 2007

Cook, ABB, Tyco, and Mettler-Toledo Gain New Managment

August 02, 2007

Washington, DC (June 25)-More than five million US adults import prescription drugs from other countries, two million of them without an official prescription, according to a survey conducted by the Pharmaceutical Research and Manufacturers of America (PhRMA). Concerned about the number of counterfeit drugs entering the US, PhRMA launched the survey to determine who was importing prescription drugs and why.

August 02, 2007

This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.

August 02, 2007

USP is revising key documents to make them easier to use.

August 02, 2007

Industry and regulatory experts provide advice on inspection preparation and best practices.