Profile is a relationship between a response variable and one or more independent variables which can describe quality of a process or a product. On the other hand, for an in-control process, capability indices are criteria for the process quality improvement that allows to meet customers’ expectations. Despite a considerable number of applications and monitoring methods already proposed for pr...

The US Pharmacopeia (USP) Therapeutic Peptides Expert Panel was formed in 2013 to evaluate quality attributes for synthetic peptide APIs based on currently available regulatory guidance and expectations. This series of three articles by the panel explores the current manufacturing and regulatory landscape and provides a comprehensive overview of quality attributes to be considered for successfu...

The coupling of liquid chromatography and mass spectrometry (LC/MS) has been established as one of the most powerful tools in analytical chemistry and has resulted in important advances especially in biomedical and biochemical research. The predominantly used interfaces are electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI). Non-polar compounds, however, are diffi...

Intelligent tutoring systems (ITS) aim at development of two main interconnected modules: pedagogical module and student module. The pedagogical module concerns with the design of a teaching strategy which combines the interest of the student, tutor’s capability and characteristics of subject. Very few effective models have been developed which combine the cognitive, psychological and behaviora...

PURPOSE Gastrointestinal stromal tumors (GISTs) are specific KIT expressing and KIT-signaling driven mesenchymal tumors of the human digestive tract, many of which have KIT-activating mutations. Previous studies have found a relatively homogeneous gene expression profile in GIST, as compared with other histological types of sarcomas. Transcriptional heterogeneity within clinically or molecularl...

Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufacturing control of a medicinal product powder mixture containing active pharmaceutical ingredient (API). Aiming at initiating a Process Analytical Technology (PAT) activity, the first step was a stationary mode at-line evaluation. In this, the content of pharmaceutical active compound in the powder mi...

Background: Commercial diagnostics are commonly used to identify gram-positive bacteria. Errors have been reported mostly at the species level. We have found certain phenotypic criteria used in API systems which significantly misidentify Leuconostoc, an emerging human pathogen, at the genus level. We also attempt to find practical, conventional phenotypic assays for accurate identification of t...

Reduced-nitrogen compounds (RNC), such as ammonia and amines, play important roles in atmospheric aerosol nucleation, secondary organic (SOA), cloud formation processes. Fast measurements of amines are made with a chemical ionization mass spectrometer (CIMS). Clusters containing RNC measured an pressure interface time flight (APi-TOF) or APi-TOF (CI-APi-TOF). Aerosol-phase can be detected singl...