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.

European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs.

Since the publication of "Application Guideline for Western Traditional Herbal Medicines as OTC Drugs" in 2007, only two European ethnopharmaceuticals, L., folium extract (Antistax) and L., fructus extract (Prefemin), have been approved as OTC drugs in Japan.

LC-MS-based quantification method for Achyranthes root saponins.

A liquid chromatography mass spectrometry (LC-MS) method was developed for simultaneous quantitative analysis of Achyranthes root saponins: chikusetsusaponins IVa (1) and V (2), achyranthosides B (3), C (4), D (5), E (6), and G (7), sulfachyranthosides B (8) and D (9), and betavulgarosides II (10) and IV (11). Satisfactory separation of the saponins was achieved with the use of a volatile ion-pair reagent (dihexyl ammonium acetate) on a phenyl-hexylated silica gel column, and the amounts of saponins extracted under three different conditions were determined. When Achyranthes root was extracted with water at room temperature, achyranthosides B (3) and D (5) were the major saponins, and smaller amounts of other saponins (4, 6-11) were present.

Two new sulfated oleanan saponins from Achyranthes root.

Two new sulfated oleanan saponins, sulfachyranthosides B (1) and D (2), were isolated from a water extract of Achyranthes root (root of Achyranthes bidentata). The structures were determined by analyses of spectroscopic data to be sulfates of achyranthosides B and D, respectively, at the 4'-position of the glucose moiety attached to the C-28 carboxylic acid of oleanolic acid.