[Current state of and challenges in in vivo central nervous system evaluation in safety pharmacology studies-Topic overview and initiatives of the Japanese Safety Pharmacology Society].

The modified Irwin's method and functional observational battery (FOB）used in non-clinical studies for predicting side effects that may appear in the central nervous system (CNS）in clinical studies consist of mainly macroscopic observation and largely depend on the observer's ability. Therefore, appropriate training for the observer and consistency of findings are extremely important, making it necessary for methods and judgment criteria to be standardized. In addition, because of concern for animal welfare as well as an increase in biopharmaceutical and anticancer drug development, there is increasing opportunity to incorporate safety pharmacological evaluation into general toxicity studies. While CNS evaluation can be incorporated into general toxicity studies relatively easily, studies need to be designed in such a way that reliable data can be obtained without reducing the ability to detect neurobehavioral abnormalities. It is therefore important to improve CNS evaluation techniques and to share these techniques with new observers in order to reliably detect the effects on the CNS during drug development.

Acupuncture Improves Sleep Conditions of Minipigs Representing Diurnal Animals through an Anatomically Similar Point to the Acupoint (GV20) Effective for Humans.

Acupuncture, an alternative medicine, has been widely applied for people with sleep disturbances; therefore, the effects should be evaluated objectively. Micro-minipigs (MMPigs), the smallest miniature pigs for animal experiments, were used. Acupuncture was performed at two different points: Dafengmen is located on the head and is an anatomically similar point to human-Baihui (GV20), an effective acupoint for sleep disturbances in humans; pig-Baihui is on the back. The procedure was performed as follows: shallow, within 5 mm depth for several seconds; deep, 10-20 mm depth for 20 min. The sleep conditions were evaluated by actigraph, and the amount of catecholamine in pooled urine after acupuncture treatment. MMPigs with deep acupuncture at Dafengmen showed significantly efficient values on actigraph and catecholamine analysis as compared with untreated MMPigs. The effective acupoint for sleep conditions in the porcine model is at an anatomically similar point to humans, rather than the point determined by traditional Chinese medicine.