MedDRA Labeling Groupings to Improve Safety Communication in Product Labels.

The granularity and structure of the International Council for Harmonisation's (ICH) Medical Dictionary for Regulatory Activities (MedDRA) are useful for precise coding of adverse events (AEs) for data analysis. In product labeling for healthcare practitioners, however, the granularity of MedDRA Preferred Terms (PTs) can obscure the communication of adverse reactions (ARs). Driven by a focus on patient safety, business needs, and regulatory guidance, many sponsors and regulators have begun to develop institution-specific approaches to clustering similar AR terms in medical product prescribing information on a product-by-product basis.

High precision isotope ratio measurements on by thermal ionization mass spectrometry using ion.

Studies were carried out to determine the 10B/11B isotope ratio by positive thermal ionization mass spectrometry (P-TIMS) analyzing boron as rubidium borate ions. Of the 36 different ionic species formed, the boron and rubidium isotope ratios were obtained from the ion intensity ratios of the most suitable ion pairs corresponding to masses 212, 213 and 215, 213 respectively. The investigations were carried out to explore the possibility of correcting the observed isotope ratio of boron by using a modified internal normalization technique based on the observed Rb isotope ratio.

Determination of boron at sub-ppm levels in uranium oxide and aluminum by hyphenated system of complex formation reaction and high-performance liquid chromatography (HPLC).

Boron, at sub-ppm levels, in U3O8 powder and aluminum metal, was determined using complex formation and dynamically modified reversed-phase high-performance liquid chromatography (RP-HPLC). Curcumin was used for complexing boron extracted with 2-ethyl-1,3-hexane diol (EHD). Separation of complex from excess reagent and thereafter its determination using the online diode array detector (DAD) was carried out by HPLC.