The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study.
The author reviews dimensional analysis as a straight-forward approach to scale up.
The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.
The author points out some major obstacles to effective scale-up and describes methods available to pharmaceutical scientists for addressing scalability issues.
In the manufacture of many pharmaceutical products, dry-particle blending is a critical step that directly affects content uniformity.
CBER Draft Guidance for Spore-Formers and Plasmid Vaccines
FDA Creates New Drug Safety Board
Lilly Implements Bar Coding on Individual Insulin Vials
Drug Safety Top Issue for New FDA Commissioner Crawford
Generic Drug for HIV/AIDS Gains FDA's Tentative Approval
The United States Pharmacopeia should not change its philosophical position on singlet testing.
FDA cites Essential Pharmacy Compounding (Omaha) for bulk-compounding of verterinary drugs.
Warning Letter
ISA-88 Automation Standard Gains IEC PAS Status
MHRA to Reinspect Chiron Flu Vaccine Plant
FDA Warning Letters December 2004
NABP Issues Criteria for "Specified List" of Drugs Susceptible to Diversion
A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented.
Comparative studies of the US Pharmacopeia (645) "Conductivity" and the European Pharmacopeia "Heavy Metals" tests were conducted to demonstrate that the USP method can determine the presence or absence of heavy metals in process water samples.
This article provides guidance for developing dissolution testing for poorly soluble compounds. It is the second of a series of articles based on material from a 2003 PhRMA workshop about acceptable analytical practices.
Pharmaceutical Science & Technology News
On the other hand, if we don't keep up the pressure on counterfeiting in the US, we may share the plight of the developing world, where nearly 25% of all drugs sold are fakes.
Defenders of the research-based industry are hoping for an early Christmas present from the European Court of Justice (ECJ). All the signs are that a small but significant victory is on the way against parallel importing. Right at the end of October, a senior judge responsible for a leading case at the court made clear his view that international drug firms do not necessarily have to make life easy for parallel importers. The formal ruling on the case at issue is expected within weeks.
Amid the finger-pointing, hand-wringing, and bloviating, the supply of hard, technical information remains frustratingly small.
This article provides guidance for minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs.
