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Volume 116, Issue 1
Displaying 1-7 of 7 articles from this issue
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Chikuma HAMADA, Hideki ONO2000 Volume 116 Issue 1 Pages 4-11
Published: 2000
Released on J-STAGE: January 30, 2007
JOURNAL FREE ACCESSBiostatistics has an important role in both designing a pharmaceutical experiment and evaluating its result. Randomization techniques are essentially important in designing an experiment. The goal of randomization is transforming systematic errors into random errors and confirming comparability among experimental groups. Randomization also provides a rationale for applying statistical tests. Combining randomization techniques with blinding and local control enables us to construct a scientifically reliable and effective experiment. An appropriate statistical analysis absolutely depends on the method of randomization. In order for a pharmacological study to be successful, it is very important to consider statistical aspects in the designing stage.View full abstractDownload PDF (8067K) -
Osamu KOMIYAMA, Atsuyoshi HIRATA, Jun HANDA2000 Volume 116 Issue 1 Pages 12-17
Published: 2000
Released on J-STAGE: January 30, 2007
JOURNAL FREE ACCESSWhen pharmaceutical scientists describe characteristics of a drug or when they decide whether it is appropriate to initiate clinical trials to determine the drug's effects in humans, their inferences are frequently grounded in information drawn from non-clinical studies. Therefore, certain and highly objective information is required. By introducing the concept of design of experiments to control some nuisance factors and performing confirmatory studies based on sample size estimation, trustworthy information can be efficiently obtained. This paper does not demand that researchers conduct an additional confirmatory study in a series of studies conducted so far. This is a reconsideration how a series of studies should be carried forward. Statistics ought to contribute much more not only to estimation or hypothetical tests after data are collected, but also to methodology of preliminary experiments and planning of studies. Cooperation with statisticians from an early stage of the studies is all the more helpful in non-clinical studies, in which, in a sense, “perfect” experiments can be conducted more than in clinical studies.View full abstractDownload PDF (7593K) -
Masayuki YAMADA, Toshio HASHIMOTO, Hiroshi MAEDA2000 Volume 116 Issue 1 Pages 18-22
Published: 2000
Released on J-STAGE: January 30, 2007
JOURNAL FREE ACCESSIn order to develop a new drug with scientific rationale, it is important to design a study properly. We suggested appropriate statistical considerations in the course of planning the study that are helpful for correct evaluation of the results of a pharmacological study, the information of which will be reflected in the planning of subsequent pharmacological and clinical studies. The statistical considerations for designing a pharmacological study are as follows: 1. clarification about the purpose of the study, 2. clear statement about the endpoint of the study, 3. framing of hypotheses, 4. selection of statistical analysis method, 5. statistical considerations about study design, 6. statistical considerations of planning about statistical analysis and describing the statistical analysis. We expect researchers will be able to obtain a more reliable conclusion by preparing a study protocol taking our suggestions into consideration.View full abstractDownload PDF (6105K) -
Toshio HASHIMOTO, Masayuki YAMADA, Hiroshi MAEDA2000 Volume 116 Issue 1 Pages 23-28
Published: 2000
Released on J-STAGE: January 30, 2007
JOURNAL FREE ACCESSIn order to develop a new drug with scientific rationale, it is important to collect and analyze data in accordance with the protocol and to report it correctly. We suggested appropriate statistical considerations with regards to the following five points for preparing a study report on a pharmacological study: 1. For describing statistical analysis, it is important to describe the applied statistical methods concretely; 2. For describing subjects included in the analysis, it is necessary to describe the number of subjects excluded from analysis along with the reasons for their exclusion, and it is important to describe the comparability among groups; 3. For preparation of tables and figures, it is necessary to prepare tables and figures with sufficient statistical information; 4. For proper expression of the results and a meaningful discussion, we suggested the importance of drawing pharmacological conclusions with sufficient knowledge of the applied statistical methods and also suggested the statistical considerations for utilizing information obtained from the results; 5. For compiling an integrated report from two or more study reports, we suggested statistical considerations for discussing the consolidated results. We expect researchers will be able to obtain more reliable conclusions by preparing a study report taking our suggestions into consideration.View full abstractDownload PDF (6622K) -
Norisuke KAWAI, Masashi GOTO2000 Volume 116 Issue 1 Pages 29-35
Published: 2000
Released on J-STAGE: January 30, 2007
JOURNAL FREE ACCESSA quantal response bioassay is defined as an experiment for estimating the potency of a drug, material or process by means of the reaction (quantal response) that follows its application to living matter. For example, the main object of bioassays in drug development is to measure the potency of some new compounds relative to some standard drug in terms of magnitudes of their effects on responses from living subjects. The quantitative estimates of their potency are summarized by comparing these dose-response curves. In this paper, we focus on analyses intended to compare two dose-response curves with quantal response and consider the model validation and the interpretation of fitting results from a statistical point of view.View full abstractDownload PDF (7398K) -
Toshimasa YOSHIOKA, Fujiko TSUKAHARA2000 Volume 116 Issue 1 Pages 36-42
Published: 2000
Released on J-STAGE: January 30, 2007
JOURNAL FREE ACCESSThe fluorescent proteins have expanded various aspects of biological research. Proteins fused to the fluorescent proteins such as green fluorescent protein (GFP) provided researchers an opportunity to visualize the intracellular trafficking of proteins in living cells. The trafficking of proteins including that of steroid receptors involves dynamic interactions with cellular proteins such as heat shock proteins, immunophilins. Such interactions, which can be monitored by GFP fusion proteins, may be altered by pathophysiological conditions and by drugs. Thus, GFP fusion proteins may be applied to the investigations for the pharmacological manipulation of protein trafficking.View full abstractDownload PDF (7448K) -
Hiroyuki WAKABAYASHI, Kenji ONODERA2000 Volume 116 Issue 1 Pages 43-48
Published: 2000
Released on J-STAGE: January 30, 2007
JOURNAL FREE ACCESSTo investigate the physiological roles of vitamin K analogues in bone metabolism, especially in osteoporosis, we have developed a sensitive and simple analysis system for vitamin K analogues in the serum and bone. After the separation of vitamin K analogues on a reversed-phase column, the analogues were reduced once in a platinum catalyst reduction column on-line and then monitored quantitatively by electrochemical detector (EICOM ECD-300) operated in the oxidation mode (+0.6 V vs. Ag AgCl). The detection limits at a signal-to-noise ratio of 3 were 2-10 pg for vitamin K analogues. We also investigated the extraction procedures for the vitamin K analogues from serum and bone. Quantitative recoveries from serum and bone were.obtained in the range of 80-101% for vitamin K analogues. We could determine both the circulating vitamin K levels in osteoporotic patients and the vitamin K contents in trabecular and cortical bone of osteoarthritis.View full abstractDownload PDF (6086K)
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