A magnetic anti-cancer compound for magnet-guided delivery and magnetic resonance imaging.

Research on controlled drug delivery for cancer chemotherapy has focused mainly on ways to deliver existing anti-cancer drug compounds to specified targets, e.g., by conjugating them with magnetic particles or encapsulating them in micelles.

Exploring Ethnic Differences in Toxicity in Early-Phase Clinical Trials for Oncology Drugs.

During oncology drug development, it is important that ethnic differences are evaluated to determine the optimal dose and administration schedule in a new region based on the clinical data from other regions. The objective of this study was to explore the possibility of detecting ethnic differences in toxicity during early-phase clinical trials. Data were reviewed from phase I clinical trials for new drug applications conducted in Japan and Western countries.

Points to consider on the non-clinical safety evaluation of anticancer drugs.

Since malignant tumors are life-threatening, the death rate from these diseases is high, and existing therapies have limited effectiveness, it is desired to provide new effective anticancer drugs to tumor patients sooner. However, there is no guideline regarding non-clinical safety studies on the development of anticancer drugs required for the first in human clinical trials and for the approval applications in Japan. Then, the Ministry of Health, Labour and Welfare (MHLW) established the collaboration group including regulatory, academic and industrial scientists to prepare the guideline on the non-clinical safety evaluation of anticancer drugs in 2004.

[Consideration of clinical development for new anticancer drugs on Japan, proposal from approval reviewer].

There become problems about a delay on clinical development of anticancer drug in Japan and drug lag. I consider causes and solutions of the problems from a position of drug approval reviewer. I think the drug lag may cause by stating later state in global clinical development or stagnation of clinical trial activities.

[Improvement of package insert CYP information for prescription drugs marketed in Japan].

In clinical practice, one drug is frequently used in combination with one or more other drugs, rather than as a sole regimen, and therefore healthcare providers need to carefully consider drug interactions. As mechanisms of drug interactions, metabolic enzymes of drugs are seen as one of the most likely interactive sites, where a majority of drugs are metabolized by cytochrome P450 (CYP). For this reason, providing appropriate information on CYP in package inserts is of grave importance.

Undesirable effects of citrus juice on the pharmacokinetics of drugs: focus on recent studies.

It is well known that intake of grapefruit juice affects the pharmacokinetics of various kinds of drugs. It has been reported that other citrus juices also interact with certain drugs. To re-evaluate citrus juice-drug interactions based on currently available evidence, a literature search was conducted for new and updated information since the grapefruit juice-drug interaction was last reviewed in 1998.