September 17th 2025
The Phase IIa study will test HTL0039732 in combination with immunotherapy to boost responses in resistant solid tumors and broaden treatment choices.
September 12th 2025
Design of an Aseptic Process Simulation
September 2nd 2004The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.
Characterization of the Performance of Bin Blenders-Part 3 of 3: Cohesive Powders
September 2nd 2004In this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.
Physicochemical Approaches to Enhancing Oral Absorption
September 1st 2004This article reviews various physicochemical approaches that may be employed to enhance absorption following oral administration of solid dosage forms in humans. This article also examines strategies based on capitalizing or neutralizing physiological processes.
The Introduction of Qualitative Rapid Microbiological Methods for Drug-Product Testing
September 1st 2004FDA recently approved the first PAT applications for the introduction of rapid microbial testing of drug products and pharmaceutical-grade waters. Officials from FDA and GlaxoSmithKline worked together to ensure the appropriate scientific evaluation of the methods. Team members report on the successful validation approach and identify technical issues to be considered for the future.
Paperless Reporting: How to Satisfy FDA
August 1st 2004Most, if not all, pharmaceutical companies today are moving towards a paperless reporting structure. This article examines FDA's 21 CFR Part 11 regulations, which relate to technical and procedural compliance for electronic records and signatures.
The LR Method in Critical Areas: Airflow Patterns and the Design of Aseptic Interventions
July 2nd 2004The limitation-of-risks (LR) method can be used as an engineering tool in risk assessment work for the identification, minimization, and evaluation of potential airborne risks, and for the identification of adequate monitoring points.
The Future of Compaction Pharmaceutical Tableting in the Twenty-First Century
June 1st 2004Currently, high-production rates and continuous production processes favor existing tableting technologies. However, if tablet development becomes rate-limiting in the future, alternative technologies may prove attractive.
Characterization of the Performance of Bin Blenders Part 1 of 3: Methodology
May 2nd 2004In this series of articles, bin blender performance is comprehensively reviewed using both free-flowing and cohesive mixtures. In part 1, an introduction to tools and techniques is presented, followed by an examination of parameter effects, mixing mechanisms, and the effects of cohesion on mixing.