Newsletter Volume 37, Number 4, 2022

Newsletter Volume 37, Number 4, 2022


 The hot days are still continuing, and the cicadas are singing with increasing intensity. The lingering summer heat is expected to be severe again this year, so please be careful not to suffer from heat stroke.

 The Sustainable Development Goals (SDGs) seem to be actively taken up in the field of education, and with the increasing number of opportunities to discuss them with children and their experiences of global warming, I feel that awareness of the SDGs is becoming more widespread these days. Overseas, while the number of tourists has decreased dramatically due to the Corona disaster, the marine environment has improved, and a business model that balances tourism and the environment is being actively utilized in the after-Corona area, where tourists are offered incentives in exchange for their participation in marine conservation activities. Since I sometimes go to the beach with my children, I looked into efforts in Japan, and found that sustainable tourism is attracting attention and tourists’ awareness is increasing in an effort to reduce the environmental impact of inbound tourism demand. It seems that efforts toward a new normal future in which everyone can develop sustainably while preserving the beauty of nature have indeed begun. At the annual meeting in Yokohama this fall, I would like to fully enjoy the normal, where I can actively discuss and exchange ideas with the participants while practicing the new normal and feeling the future of pharmacokinetics research. The seventh wave of coronary infection is continuing, and I can only hope that it will subside soon, but I would like to get through this hot summer without forgetting my excitement for the future. (K.I.)

Introduction of Feature Articles


 With the development of new discoveries, new methods, and other academic advances, the evaluation items and methods for pharmaceuticals and other products are constantly evolving from R&D to post-marketing evaluation. Correspondingly, regulatory information from regulatory authorities in Japan, the U.S., and Europe, as well as ICH and other regulatory bodies, is constantly being updated. Here, we will introduce the latest technologies and findings used in drug development, regulatory information on drug review, and related information topics. We hope that this article will be of use to our members in their work.

Introduction to Pharmacokinetic Studies in Research and Development of Cell Therapy Products

 Cell therapy is an innovative treatment that modifies or repairs the functions of cells, tissues, or organs by administering or transplanting living cells to patients. In the research and development of cell therapy products, cellular kinetics (CK) evaluation, which evaluates the concentration of cells in the blood over time, and biodistribution (BD) evaluation, which evaluates the migration of the product into tissues, are conducted. Since the properties of cell therapy products are very different from those of small molecule compounds, antibody drugs, nucleic acid drugs, etc., it is necessary to go beyond conventional wisdom in study design and data interpretation when assessing pharmacokinetics. In this article, we will introduce analytical methods for CK and BD evaluation of cell therapy products, pitfalls that experimenters often fall into when evaluating CK/BD, basic characteristics of CK and BD of cell therapy products, and usefulness of modeling and simulation for CK/BD analysis in several articles.

Pharmacokinetic Research by Young Scientists

 In this section, young researchers who will support pharmacokinetic research in the future will appear and introduce their latest research activities. Pharmacokinetics is constantly evolving, and we feel that it is expanding in new directions from the study of drug movement. Through this corner, we will introduce the latest research trends of young researchers who will create the future trends of pharmacokinetics. You will be able to experience the innovative ideas and research power of young researchers.