title: [The Contribution of GMP-grade Hospital Preparation to Translational Research].
abstract: Translational research is important for applying the outcomes of basic research studies to practical medical treatments. In exploratory early-phase clinical trials for an innovative therapy, researchers should generally manufacture investigational agents by themselves. To provide investigational agents with safety and high quality in clinical studies, appropriate production management and quality control are essential. In the Department of Pharmacy of Kyoto University Hospital, a manufacturing facility for sterile drugs was established, independent of existing manufacturing facilities. Manuals on production management and quality control were developed according to Good Manufacturing Practices (GMP) for Investigational New Drugs (INDs). Advanced clinical research has been carried out using investigational agents manufactured in our facility. These achievements contribute to both the safety of patients and the reliability of clinical studies. In addition, we are able to do licensing-out of our technique for the manufacture of investigational drugs. In this symposium, we will introduce our GMP grade manufacturing facility for sterile drugs and discuss the role of GMP grade hospital preparation in translational research.
authors.affiliation: Department of Clinical Pharmacology & Therapeutics, Kyoto University Hospital.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Yonezawa
authors.forename: Moto
authors.initials: M
authors.lastname: Kajiwara
authors.forename: Ikuko
authors.initials: I
authors.lastname: Minami
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Omura
authors.forename: Shunsaku
authors.initials: S
authors.lastname: Nakagawa
authors.forename: Kazuo
authors.initials: K
authors.lastname: Matsubara
mesh_terms: D002986:Clinical Trials as Topic; D015507:Drugs, Investigational; D007391:International Cooperation; D007564:Japan; D061214:Patient Safety; D004364:Pharmaceutical Preparations; D010607:Pharmacy Service, Hospital; D011786:Quality Control; D013242:Sterilization; D057170:Translational Research, Biomedical
chemical_list: D015507:Drugs, Investigational; D004364:Pharmaceutical Preparations