Stabilization of borate by hot isostatic pressing after co-precipitation with hydroxyapatite using MAP.

Boric acid is one of the most mobile inorganic contaminant species in nature due to its pKa of 9.23. Co-precipitation of borate with hydroxyapatite (HAp: Ca5(PO4)3OH) facilitates the simultaneous removal of borate with co-existing oxoanions in natural waters. The cost of phosphate is an impediment to industrialize the co-precipitation of borate with HAp for treatment of geothermal waters. In the present work, an inexpensive industrial by-product of magnesium ammonium phosphate (MAP) derived from sewage sludge, was examined as a phosphate source. MAP includes 89% pure magnesium ammonium phosphate, resulting in better performance than the pure chemical form of NH4H2PO4, because Mg2+ and Al3+ (trace elements in MAP product) play roles in enhancing the removal rate of borate and lowering the equilibrium borate concentration. These ions have a good affinity with phosphate to nucleate crystal seeds independently of powdery Ca sources. To reduce the bulky volume of solid residues, hot isostatic pressing (HIP) was applied. There is structural water in HAp; therefore, the greatest volume reduction was achieved with 78.3 ± 2.0% (n = 3). Additionally, a synergic effect to suppress the released borate, greater than the sequential combination of calcination and cold isostatic pressing was accomplished in the toxicity contents leaching procedure (TCLP) test. This is not due to larger crystal sizes alone, but it is derived from boron stabilization in HAp at an atomic level by the synergic effect of heating and pressing simultaneously.

Scientific considerations for global drug development.

Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.

Evolving Vision of Regulatory Science in the Global Medical Community.

"Regulatory science" (RS) has been defined in various ways, but, nevertheless, the definitions of RS in different parts of the world include many common elements. It seems to be a common view that RS is not basic or applied science but, rather, focuses on the estimation and prediction of safety and efficacy. Thus, we think RS overall should incorporate not only RS specifically for medical product assessment but also RS engineering to provide prediction and estimation tools for those purposes, including guideline/guidance development. It is important as well to consider the potential contribution of RS to rational medicine (i.e., to evidence-based medicine in a broader context), and especially to real-world evidence generation. We will look at how definitions of RS have evolved, and how we believe RS might develop in the future. Taking a patient-centric view, we re-emphasize RS is an ethical science contributing to society and human welfare.