One of the most enduring points of confl ict in the global political economy is whether international economic rules and regulations should accommodate diversity or encourage harmonization of regulatory institutions. The logic of diff erentiation is that optimal regulatory design diff ers according to national needs and conditions. The logic of harmonization, in contrast, is that the transactio...

Similar to the 2006 consensus statement on the standardization of growth hormone (GH) assays (1 ), the guidelines regarding improvement of assay comparability in a recent consensus statement in Clinical Chemistry (2 ) are limitedto the recommendation to the recommendation of common use of the Second International Standard for Somatropin (IS 98/574), although it is recognized that discrepancies ...

A simple, sensitive, specific, spectrophotometric method was developed for the detection of Olmesartan medoxomil (OLM) in bulk and pharmaceutical formulations. The optimum conditions for the analysis of the drug were established. OLM was subjected to stress degradation under different conditions recommended by the International Conference on Harmonization (ICH). The samples so generated were us...

Genotoxicity is the most commonly used endpoint to predict the carcinogenicity of chemicals. The International Conference on Harmonization (ICH) M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk offers guidance on (quantitative) structure-activity relationship ((Q)SAR) methodologies that predict the outcome of b...

A simple and inexpensive titrimetric method for the determination of magnesium ion in esomeprazole magnesium raw material was developed and validated according to International Conference on Harmonization guidelines and the United States Pharmacopoeia. The method depends on complex formation between EDTA and magnesium ion. The method was proven to be valid, equivalent and useful as an alternati...