大学における臨床製剤設計の事例とそのニーズへの対応

抄録

In the healthcare setting, the handling of clinical preparations is essential for the development of tailor-made pharmaceutical agents. However, during the design and development of new clinical formulations, pharmacists may encounter various questions and problems related to handling the formulations, such as a lack of knowledge of and experience in prescription design. In addition, if pharmacists require assistance to solve problems, it is rare to find a person with sufficient knowledge of and experience with the formulation in their facilities, and there are few connections among facilities; therefore, in practice, no consultants are available for advice. Universities may play an important role in solving this problem. We believe that it would be beneficial for both clinical practitioners and universities to develop a plan-do-check-action (PDCA) cycle that brings needs, problems, and questions from clinical sites to universities where research is conducted and the results are fed back to the clinics. This complements one of the major missions of universities as research institutes, which is to compile evidence. For new drug candidates that require a high degree of support from universities, the demonstration of sufficient safety information to warrant clinical trials and subsequent drug development will increase pharmacists' awareness of drugs and lead to uptake of formulations. This paper introduces the case for clinical formulation design in universities as part of the C (check) element of the PDCA cycle and how this corresponds to the needs of the pharmaceutical industry.