Drug Development

In this article, the author explains some of the technology behind using ion-exchange resins for drug delivery...

This article examines the importance of core design and formulation on the quality of a film coated tablet...

Warning Letters: Alternative Health and Patient First

FDA New Drug Review Times Continue to Drop in 2004

Warning Letter: Germiphene

Warning Letter: Germiphene

USP to Publish Spanish Translation of USP-NF; Council of Experts Named

"Stable Liquid" Technology Permits Heptavalent Vaccine Against Botulism

Warning Letters: DanChem Technologies & Medsep

Nanoparticle Synthesis Process Facilitates Chiral Separations

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