臨床製剤の市販化を目指した橋渡し研究─臨床製剤データベースの構築と有用性評価─

抄録

Hospital-prepared drugs, as one form of off-label use, are prepared by pharmacists in individual Japanese hospitals. More than 20 originally hospital-prepared drugs have become commercially available in Japan, although the number reaching the commercialization stage has decreased recently. In this study, we show our recent approach to developing hospital preparations into commercially available drugs. Our first endpoint was to start phase 2 clinical trials of hospital-prepared drugs. The second endpoint was to determine whether the drugs could continue to phase 3 trials. We have developed an evidence database on 107 hospital-prepared drugs by performing a literature survey on each drug for references to the words “stability”, “efficacy”, and “safety”. If evidence is lacking, in vitro study results are compiled in the database, which will be needed when initiating clinical trials. So far, a phase 2 clinical trial of one hospital-prepared drug has been completed, and we have started stability testing of some drugs for which evidence of stability is lacking. This paper presents our recent approach to developing hospital preparations into commercially available drugs.