[Translational Research Focused on Hospital-prepared Drugs in Japan: Developing and Accessing an Approach Using an Evidence Database].

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. PMID: 31582615 [PubMed - in process]
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - Category: Drugs & Pharmacology Authors: Tags: Yakugaku Zasshi Source Type: research