Drug Development

The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.

The United States Pharmacopeia should not change its philosophical position on singlet testing.

This article looks at how to adopt a systematic and prospective approach in the API development process to achieve documented, controlled synthetic processes...

FDA cites Essential Pharmacy Compounding (Omaha) for bulk-compounding of verterinary drugs.

Warning Letter

Albumin-Bound Nanoparticle Drug Nabs FDA Approval

MHRA to Reinspect Chiron Flu Vaccine Plant

FDA Warning Letters December 2004

Cellular Chemical Factory Lowers Cost of Malaria Treatment

Engineered Oilbodies Produce Vaccines and Adjuvants

Engineered Oilbodies Produce Vaccines and Adjuvants

The author reviews the effects of moisture on flow properties, tensile strength, Heckel plot, energies involved in compaction, and elastic recovery.

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.

From solving complex formulation challenges to delivering full product-development programs, outsourcing services organizations provide valuable expertise, experience, and technical know-how.

The authors examine the effects of three superdisintegrants on the dissolution and absorption of tenoxicam from solid-dispersion formulations.

This article examines the different types of dessicants avaliable to the pharmaceutical industry. It provides information on choosing the right type, and how and when it should be used.

Microspheres of Eudragit RL were developed for colonic delivery of albendazole. The effects of polymer concentration, stirring rate, and concentration of emulsifier on particle size and drug loading were studied. A comparative in vitro drug release study of the optimized formulation was carried out.

Pharmaceutical Science & Technology Innovations

Researchers are improving photodynamic therapies with new photosensitizers and light sources for deeper tissue penetration, more site-specific treatments, and reduced side effects.

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.

A harmonized global specification is possible providing that the procedures and acceptance criteria defined are acceptable to regulatory authorities in all regions.

Amid the finger-pointing, hand-wringing, and bloviating, the supply of hard, technical information remains frustratingly small.