Drug Development

As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into their validation process.

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.

International Specialty Products (ISP) and Niro A/S have formed an alliance to develop and market spray drying and formulation technologies...

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

Extrusion-spheronization and pellet compression are effective means of developing first-order kinetic, controlled-release drug delivery systems of azithromycin (AZI). The authors prepared, evaluated, and optimized AZI formulations and assessed the stability of the selected formulation under accelerated storage conditions.

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.