Related Articles Measuring medicine prices in Peru: validation of key aspects of WHO/HAI survey methodology. Rev Panam Salud Publica. 2010 Apr;27(4):291-9 Authors: Madden JM, Meza E, Ewen M, Laing RO, Stephens P, Ross-Degnan D OBJECTIVES: To assess the possibility of bias due to the limited target list and geographic sampling of the World Health Organization (WHO)/Health Action International (HAI) Medicine Prices and Availability survey used in more than 70 rapid sample surveys since 2001. METHODS: A survey was conducted in Peru in 2005 using an expanded sample of medicine outlets, including remote areas. Comprehensive data were gathered on medicines in three therapeutic classes to assess the adequacy of WHO/HAI’s target medicines list and the focus on only two product versions. WHO/HAI median retail prices were compared with average wholesale prices from global pharmaceutical sales data supplier IMS Health. RESULTS: No significant differences were found in overall availability or prices of target list medicines by retail location. The comprehensive survey of angiotensin-converting enzyme inhibitor, anti-diabetic, and anti-ulcer products revealed that some treatments not on the target list were costlier for patients and more likely to be unavailable, particularly in remote areas. WHO/HAI retail prices and IMS wholesale prices were strongly correlated for higher priced products, and weakly correlated for lower priced products (which had higher estimated retailer markups). CONCLUSIONS: The WHO/HAI survey approach strikes an appropriate balance between modest research costs and optimal information for policy. Focusing on commonly used medicines yields sufficient and valid results. Surveyors elsewhere should consider the limits of the survey data as well as any local circumstances, such as scarcity, that may call for extra field efforts. PMID: 20512232 [PubMed - indexed for MEDLINE]
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Measuring medicine prices in Peru: validation of key aspects of WHO/HAI…
Related Articles A generic static headspace gas chromatography method for determination of residual solvents in drug substance. J Chromatogr A. 2010 Aug 13; Authors: Cheng C, Liu S, Mueller BJ, Yan Z In order to increase productivity of drug analysis in the pharmaceutical industry, an efficient and sensitive generic static headspace gas chromatography (HSGC) method was successfully developed and validated for the determination of 44 classes 2 and 3 solvents of International Conference of Harmonization (ICH) guideline Q3C, as residual solvents in drug substance. In order to increase the method sensitivity and efficiency in sample equilibration, dimethylsulfoxide (DMSO) was selected as the sample diluent based on its high capacity of dissolving drug substance, stability and high boiling point. The HS sample equilibration temperature and equilibration time are assessed in ranges of 125-150 degrees C and 8-15min, respectively. The results indicate that the residual solvents in 200mg of drug substance can be equilibrated efficiently in HS sampler at 140 degrees C for 10min. The GC parameters, e.g. sample split ratio, carrier flow rate and oven temperature gradient are manipulated to enhance the method sensitivity and separation efficiency. The two-stage gradient GC run from 35 to 240 degrees C, using an Agilent DB-624 capillary column (30m long, 0.32mm I.D., 1.8mum film thickness), is suitable to determine 44 ICH classes 2 and 3 solvents in 30min. The method validation results indicate that the method is accurate, precise, linear and sensitive for solvents assessed. The recoveries of most of these solvents from four drug substances are greater than 80% within the method determination ranges. However, this method is not suitable for the 10 remaining ICH classes 2 and 3 solvents, because they are too polar (e.g. formic acid and acidic acid), or have boiling points higher than 150 degrees C, (e.g. anisol and cumene). In comparison with the previous published methods, this method has a much shorter sample equilibration time, a better separation for many solvents, a higher sensitivity and a broader concentration range. PMID: 20801455 [PubMed - as supplied by publisher]
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