New Drug Development Strategy in Japan: Flexibility in Guideline Adherence.

Recently, a new type of drug lag, known as "drug loss" has emerged in Japan. It is a condition where the development of a drug approved in other countries has not been initiated in Japan. For 265 new drugs approved in the United States or Europe during 2010-2020, only 31% had commenced development in Japan as of December 31, 2020.

Age-Specific Dose Regimens of Dexmedetomidine for Pediatric Patients in Intensive Care Following Elective Surgery: A Phase 3, Multicenter, Open-Label Clinical Trial in Japan.

Objectives: To demonstrate the efficacy, safety, and pharmacokinetics of dexmedetomidine as a potential sedative for pediatric surgery patients in the ICU.

Design: Phase 3, multicenter, open-label study.

Setting: This study included 61 patients at 13 tertiary hospitals in Japan.

Tofacitinib for the treatment of moderate to severe chronic plaque psoriasis in Japanese patients: Subgroup analyses from a randomized, placebo-controlled phase 3 trial.

Tofacitinib is an oral Janus kinase inhibitor. These post-hoc analyses assessed tofacitinib efficacy and safety in Japanese patients with psoriasis enrolled in a 52-week global phase 3 study. Patients received tofacitinib 5 mg, tofacitinib 10 mg or placebo twice daily (b.

Is antipsychotic polypharmacy associated with metabolic syndrome even after adjustment for lifestyle effects?: a cross-sectional study.

Background: Although the validity and safety of antipsychotic polypharmacy remains unclear, it is commonplace in the treatment of schizophrenia. This study aimed to investigate the degree that antipsychotic polypharmacy contributed to metabolic syndrome in outpatients with schizophrenia, after adjustment for the effects of lifestyle.

Methods: A cross-sectional survey was carried out between April 2007 and October 2007 at Yamanashi Prefectural KITA hospital in Japan.

Intraosseous delivery of paclitaxel-loaded hydroxyapatitealginate composite beads delaying paralysis caused by metastatic spine cancer in rats.

Object: Bone is frequently the first site and the only site of breast cancer at recurrence. Local control is important especially for metastatic spine cancer, because epidural spinal cord compression is significantly associated with the quality of life and survival of these patients. The authors have developed a local delivery system of paclitaxel in the form of hydroxyapatite-alginate composite beads.