(Q34635815)

3 August 2017

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title

Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC). (English)

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3 August 2017

0 references

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Yasuhiro Fujiwara

1

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3 August 2017

Ken Kobayashi

series ordinal

2

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3 August 2017

publication date

1 May 2002

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Critical Reviews in Oncology Hematology

3 August 2017

published in

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3 August 2017

volume

42

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3 August 2017

issue

2

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3 August 2017

page(s)

145-155

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MD reviewers' role in the new anticancer drug approval process in the newly established Japanese regulatory agency, PMDEC (Pharmaceuticals and Medical Devices Evaluation Center)

3 August 2017

cites work

1 reference

https://api.crossref.org/works/10.1016%2FS1040-8428%2802%2900010-0

7 January 2021

One-sample multiple testing procedure for phase II clinical trials

1 reference

https://api.crossref.org/works/10.1016%2FS1040-8428%2802%2900010-0

7 January 2021

Optimal two-stage designs for phase II clinical trials

1 reference

https://api.crossref.org/works/10.1016%2FS1040-8428%2802%2900010-0

7 January 2021

New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada

1 reference

https://api.crossref.org/works/10.1016%2FS1040-8428%2802%2900010-0

7 January 2021

Re: new guidelines to evaluate the response to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup

1 reference

https://api.crossref.org/works/10.1016%2FS1040-8428%2802%2900010-0

7 January 2021

Current status of oral anticancer drugs in Japan.

1 reference

https://api.crossref.org/works/10.1016%2FS1040-8428%2802%2900010-0

7 January 2021

10.1016/S1040-8428(02)00010-0

Identifiers

DOI

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3 August 2017

1 reference