[Chapter 3. Transitions in clinical trials and appropriate use of drugs in Japan (1980-2010)].

This paper reviews the status of clinical trials and appropriate use of drugs from historical perspectives in the last 30 years in Japan. Industry-sponsored clinical trials in Japan began being regulated under the revised Pharmaceutical Affairs Law in 1980. Japanese modifications were made to the ICH-GCP, which reached step 4 in May 1996, and a notification called the "New GCP" was issued in March 1997.

[Development and analyses of evaluation criteria for meta-analysis-relationship between renin-angiotensin system inhibitor and diabetes mellitus].

In recent years, evidence-based medicine is practiced in medical care, and meta-analysis is positioned as the highest quality research paper. However, there are no unified criteria to evaluate meta-analysis. Thus, we developed and evaluated objective criteria of meta-analysis paper.

[Objective evaluation of generic-specific drug information].

Growth in the use of generic drugs remains flat in Japan, and one of the reasons cited is information availability. We previously showed that the amount of information available on generic drugs differs greatly from one pharmaceutical industry to another, though, on average, it is inferior to that for original, brand name drugs. This report looks at information on individual generic drug products, rather than the active ingredients contained therein.

[Evaluation of information for generic drugs based on importance and necessity].

Limited use of generics in Japan has been justified on the basis of problematic quality, distribution and information. Of these three problem areas, the state of provision of information in particular has never been objectively evaluated. We therefore sought to evaluate information according to its necessity and importance to medical practice.

Objective evaluation of generic drug information.

Pharmacists active in health care venues need to be able to evaluate generic drugs in terms of effectiveness, safety, and economy to ensure that they are used appropriately. As part of the ongoing study of these factors, we carried out an objective evaluation of information provided for generics. A minimum of 20 commercially available products was considered for each pharmaceutical ingredient.

[Calculation of drug information necessity factor of generic drugs].

The utilization of generic drugs has been promoted, but there is concern about the insufficiency of the information provided on generic drugs. To make an objective evaluation of the amount of information supplied by generic drug manufactures, we tried to quantify the information supply. The information described in the package insert and the interview form were used in the evaluation.