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Guidebook for Regulatory Pathways: Japan [Hard copy, Japanese version]
¥4,860($30.62)
Issue date:8/15/2019 Pages:86
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Guidebook for Regulatory Pathways: Japan [Hard copy, English version]
¥4,860($30.62)
Issue date:8/15/2019 Pages:86
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Complete Guide to PMDA consultation Meetings [Hard copy, Japanese version]
¥4,860($30.62)
Issue date:8/22/2018 Pages:172
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Complete Guide to PMDA consultation Meetings [Hard copy, English version]
¥4,860($30.62)
Issue date:8/22/2018 Pages:172
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Guideline for Drug Interactions for Drug Development and Labeling Recommendations
¥50,000($315.00)
Code: MU001 Issue date: 7/23/2018 Pages: 55
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Guidance for a Bioequivalency Study for Manufacturing Method Change of Oral Products
¥20,000($126.00)
Code: QA001 Issue date: 4/19/2013 Pages: 15
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Guidance for Quality Assessment of Antibody Drugs
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Code: QA002 Issue date: 12/14/2012 Pages: 16
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Q&A for "Guidance for Quality Assessment of Antibody Drugs"
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Code: QA003 Issue date: 12/14/2012 Pages: 2
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Handling of Ethical Products with Different Crystal Forms
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Code: QA007 Issue date: 6/16/2011 Pages: 4
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Guideline for Data Monitoring Committee
¥11,000($69.30)
Code: CL002 Issue date: 4/4/2013 Pages: 11
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Clinical Studies Utilizing Pharmacogenomics
¥4,000($25.20)
Code: CL004 Issue date: 9/30/2008 Pages: 4
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Guideline for Clinical Evaluation of Antibiotics
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Code: CL101 Issue date: 10/23/2017 Pages: 95
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Guidance for Clinical Evaluation of Anti-Tumor Drugs for Pediatric Malignant Tumors
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Code: CL103 Issue date: 9/30/2015 Pages: 12
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Guideline for Clinical Evaluation of Sleep Medicine
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Code: CL105 Issue date: 12/13/2011 Pages: 17
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Guideline for Clinical Evaluation of Renal Anemia Drugs
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Code: CL106 Issue date: 9/30/2011 Pages: 14
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Q&A for "Guideline for Clinical Evaluation of Renal Anemia Drugs"
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Code: CL107 Issue date: 9/30/2011 Pages: 2
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Guideline for Clinical Evaluation of Heart Failure Drugs
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Code: CL108 Issue date: 3/29/2011 Pages: 20
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Q&A for "Guideline for Clinical Evaluation of Heart Failure Drugs"
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Code: CL109 Issue date: 3/29/2011 Pages: 3
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Guideline for Clinical Evaluation of Anti-Depression Drugs
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Code: CL110 Issue date: 11/16/2010 Pages: 17
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Guideline for Clinical Evaluation of Overactive Bladder
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Code: CL114 Issue date: 6/28/2006 Pages: 14
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Q&A for "Guideline for Drug Interactions for Drug Development and Labeling Recommendations"
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Code: MU002 Issue date: 7/23/2018 Pages: 18
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Guidance for Microdose Clinical Studies
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Code: CL005 Issue date: 6/3/2008 Pages: 21
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OAB treatment algorythm
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Code: OAB01 Issue date: 2015 Pages: 10
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IBS Treatment Algorythm
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Code: IBS01 Issue date: 2014 Pages: 7