usefulness of nanoparticles, there are now safety concerns about their use. Therefore,
the importance of evaluating the safety of vulnerable generations such as
pregnant women and infants, who are highly sensitive to chemical substances,
has been pointed out worldwide. From this perspective, to analyze the risk from
nanoparticles to vulnerable generations, nano-safety science and nano-safety
design research has been conducted. The findings of these studies will lead not
only to develop a nanotechnology that will enable the sustainable use of
nanoparticles; they will also contribute to future developments in the field of
Recently, therapeutic drug monitoring is
recommended for many drugs even though the procedure is not covered by health
insurance. This Current Topic focuses on four areas: (1) anticancer drugs, (2)
anti-infective agents, (3) antipsychotics/antidepressants, and (4) antibody
drugs. Among the drugs that are not approved for insurance coverage in Japan,
the drugs for which TDM is recommended and drugs that are likely to be approved
in the future are summarized in a review, which include their pharmacokinetic
characteristics and the usefulness of TDM.
Antibodies that specifically target biomarkers are
essential in clinical diagnosis. Genetic engineering has assisted in designing novel antibodies that offer greater antigen-binding
affinities, thus providing more sensitive immunoassays. Authors have succeeded
in generating a single-chain Fv fragment (scFv) targeted estradiol-17b (E2) with more than 370-fold improved
affinity (Ka 3.2 ´ 1010
M-1), based on a strategy focusing the
complementarity-determining region 3 in the VH domain (VH-CDR3).
This improvement is the greatest reported for mutagenesis targeting
anti-steroid antibodies. The scFv mutant enabled an enzyme-linked immunosorbent
assay that provided sensitive dose-response
curves for determining E2, the midpoint of which was 4.46 pg/assay.
Fracture Risk Assessment Tool (FRAX) is a
well-known scoring system for predicting the probability of fragility fractures
(FF). However, among the factors used in FRAX, glucocorticoid is the only
medication factor. Authors assessed the risk of FF at each clinical department
using FRAX and medication patterns. As a result, the departments included in
the high-risk group by FRAX were not necessarily the same as the departments
included in the top group, based on the administered medications. Authors
recommend the use of FRAX together with prescribed medications on hospital-wide
surveillance of fracture risk assessment.
For the patient, the national health
insurance of Japan is a wonderful system which can be proud to the world.
Efficiency of medical care is an important issue to make this system
sustainable into the future. Nivolumab, a breakthrough cancer drug, is widely
effective, but its high price raises efficiency concerns. Authors performed
model-based cost-effectiveness analyses in first-line and late-line treatment
for advanced gastric cancer. The first-line treatment had an incremental
cost-effectiveness ratio of more than 7 times that of the late-line treatment.
Authors showed challenges between economics and best practices in healthcare.