Drug Development

UK MHRA Okays Chiron Flu Vaccine Plant; FDA Approval Still to Come

FDA Approves Treatment for Smallpox Vaccination Side Effects

Nanoparticle Synthesis Process Facilitates Chiral Separations

Big Pharma Companies Team Up to Develop Once-Daily, Triple-Combination HIV Drug

Some published articles purport to demonstrate the difficulties and problems of the laser diffraction technique without mentioning that these apparent problems are inherent in all particle-sizing techniques. This article discusses some of the advantages of using laser diffraction for particle sizing-including repeatability, ease of verification, and speed of measurement-and why it has become the preferred technique in a range of industries.

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

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