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Volume 30 (1999)
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Virtual issue
Volume 30, Issue 4
Displaying 1-6 of 6 articles from this issue
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1999 Volume 30 Issue 4 Pages 65E
Published: 1999
Released on J-STAGE: February 25, 2011
JOURNAL FREE ACCESSDownload PDF (272K) -
[in Japanese], [in Japanese]1999 Volume 30 Issue 4 Pages 669-674
Published: July 31, 1999
Released on J-STAGE: February 25, 2011
DOIhttps://member-cnki-net-s-1416.res.gxlib.org.cn:443/rwt/1416/https/MSYXTLUQPJUB/10.3999/jscpt.30.669JOURNAL FREE ACCESSDownload PDF (897K) -
Tadashi SUGIYAMA, Koji YASUDA, Chitoshi GOTO, Yoshihiro KATAGIRI1999 Volume 30 Issue 4 Pages 675-679
Published: July 31, 1999
Released on J-STAGE: February 25, 2011
DOIhttps://member-cnki-net-s-1416.res.gxlib.org.cn:443/rwt/1416/https/MSYXTLUQPJUB/10.3999/jscpt.30.675JOURNAL FREE ACCESSUnder the new GCP, pharmacists should manage investigational new drugs. In Gifu University Hospital, pharmacists began to manage clinical trials in April 1997. The items of management at the registration of patients for clinical trials were follows: 1) content of consent forms, 2) number of registered patients, 3) presence of contraindicated medicine in patient's medication history, etc. The items of management at dispensing were follows: 1) accuracy of administration and dosage, 2) presence of contraindicated medicine on prescription, 3) presence of a consent form signed by patients, 4) prescription by registered investigators, etc.
From April 1997 to March 1998, pharmacists managed twenty-six clinical trials that included 122 patients. Pharmacists checked 46 incidences of contravention of the protocol in this period. Items of the contravention were: prescription of a medicine that is contraindicated for the investigational drug during the study, error in administration and dosage, excess of the number of patients registered, and prescription by non-registered investigators. Physicians corrected 42 contraventions following the instructions given by pharmacists. Pharmacists checked 38 items with questions about the procedure of clinical trials in this period. The contents of the question were prescription of the medicine that is limited to use during the study, imperfection of consent forms, imperfection of prescription, and doubtful standards for registration of patients. Physicians corrected 23 items in question following the recommendations given by pharmacists.
By this investigation, it became clear that the management of clinical trials by pharmacists is very important to ensure the quality of clinical trials in a hospital.View full abstractDownload PDF (985K) -
Makoto SHIRAGAMI, Kiyohito NAKAI1999 Volume 30 Issue 4 Pages 681-688
Published: July 31, 1999
Released on J-STAGE: February 25, 2011
DOIhttps://member-cnki-net-s-1416.res.gxlib.org.cn:443/rwt/1416/https/MSYXTLUQPJUB/10.3999/jscpt.30.681JOURNAL FREE ACCESSSince the introduction of the Orphan Drug Development Support Program in 1993 in Japan, the MHW has designated 106 orphan drugs (additional 7 designations were granted but those applications were made by the request of the MHW). Among 106 drugs, 34 were approved by the Pharmaceutical Affairs Law.
The designations represent 90 compounds in which 32 biologicals were involved; 11 compounds received the designation more than once. Among 90 compounds, 54 were newly developed. The applications for orphan drug designation were made by 70 different sponsors. Of the orphan drug designations 23 were those for infections including AIDS or infectious conditions, 13 each for cancer and nerve disorders and 9 for blood disorders. Twenty-five compounds were for 15 indications classified as “nanbyou” or “recalcitrant illness”. In the 91.9% of the designated orphan drugs the number of patients for whom the designated drug will be used is estimated to be not more than 10, 000. Among 106 designations, 36 were Japanese original products. However only 9 designations contain new compounds.
Of the designated drugs 33.7% have obtained approval and 4.7% of the designations have been withdrawn. On the other hand, in USA, 19.2% have been approved and 15.5% have been withdrawn. Only a few compounds have been designated repeatedly in Japan.
Thus there is the tendency that the orphan drugs which need less development expenditure and shorter development time are selected. Such a trend can be explained by the fact that almost all orphan drugs have been developed by big companies in Japan rather than by venture companies as in USA.View full abstractDownload PDF (6429K) -
Makoto SHIRAGAMI, Kiyohito NAKAI1999 Volume 30 Issue 4 Pages 689-696
Published: July 31, 1999
Released on J-STAGE: February 25, 2011
DOIhttps://member-cnki-net-s-1416.res.gxlib.org.cn:443/rwt/1416/https/MSYXTLUQPJUB/10.3999/jscpt.30.689JOURNAL FREE ACCESSIn order to evaluate the Orphan Drug Development Support Program established in April 1993, we sent questionnaires to sponsors who developed or are developing orphan drugs and surveyed the reasons for applying for the orphan drug designation and the benefits of the Program they obtained after designation was granted.
The results show that shortening of the evaluation period and sufficient guidance and advice to sponsors have created great incentives for orphan drug R & D. On the other hand, the extension of the reexamination period, grants or tax deductions were considered less of an incentive than expected.
Of 87 sponsors, 73.6% were motivated by third parties such as MHW's research group, medical associations or patients' associations. This means that there is strong social need for orphan drugs and sponsors have developed such drugs in view of their responsibility in society.
It can be said that the Orphan Drug Devlopment Support Program has been successful to some extent from the viewpoint of providing necessary drug to medical practices. However, a more flexible opration of the Program is needed for efficient development, and further consideration would be necessary in order to enrich the guidance and advice, promote further shortening of the evaluation period, create priority distribution of the grants to small or middle-sized companies or to orphan drugs with very small markets, and to simplify the granting procedure.View full abstractDownload PDF (1014K) -
Makoto SHIRAGAMI, Kiyohito NAKAI1999 Volume 30 Issue 4 Pages 697-702
Published: July 31, 1999
Released on J-STAGE: February 25, 2011
DOIhttps://member-cnki-net-s-1416.res.gxlib.org.cn:443/rwt/1416/https/MSYXTLUQPJUB/10.3999/jscpt.30.697JOURNAL FREE ACCESSIn 1985, the MHW made an announcement by Division Director's Notice to simplify the data necessary for the application for approval of an orphan drug. In 1993, the Pharmaceutical Affairs Law was amended and the Orphan Drug Development Support Program was introduced. In this study, we compared the situation of orphan drug development among stage I (1980-1985), stage II (1985-1993) and stage III (1993-1998).
Thirty-four orphan drugs were approved during stage III (7.6 drugs/year) showing a 3.2- and 1.9-fold increase from stage I (2.4 drugs/year) and stage II (3.9 drugs/year), respectively. Orphan drugs are granted fast-track approval status. The median of the evaluation period (from application submission to approval) of approved drugs in stage III was 16 months and faster than the previous stage.
The Orphan Drug Development Support Program has encouraged orphan drug development. Orphan sponsors recognize that among several incentives under the support program's fast-track approval system, and consultation with and advice from the Drug Organization are most effective.View full abstractDownload PDF (1611K)
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