Regulatory and Clinical Trial Systems in Japan (English)
- New search for: Satake, Mamiko
- New search for: Hosoda, Natsuko
- New search for: Griffin, John P.
- New search for: Posner, John
- New search for: Barker, Geoffrey R.
- New search for: Satake, Mamiko
- New search for: Hosoda, Natsuko
In:
The Textbook of Pharmaceutical Medicine
;
537-553
;
2013
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ISBN:
- Article/Chapter (Book) / Electronic Resource
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Title:Regulatory and Clinical Trial Systems in Japan
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Contributors:Griffin, John P. ( editor ) / Posner, John ( editor ) / Barker, Geoffrey R. ( editor ) / Satake, Mamiko ( author ) / Hosoda, Natsuko ( author )
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Published in:The Textbook of Pharmaceutical Medicine ; 537-553
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Publisher:
- New search for: Blackwell Publishing Ltd.
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Place of publication:Oxford, UK
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Publication date:2013-04-18
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Size:17 pages
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ISBN:
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DOI:
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Type of media:Article/Chapter (Book)
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Type of material:Electronic Resource
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Language:English
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Keywords:
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Source:
Table of contents eBook
The tables of contents are generated automatically and are based on the data records of the individual contributions available in the index of the TIB portal. The display of the Tables of Contents may therefore be incomplete.
- 1
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Discovery of New MedicinesRibeill, Yves J. et al. | 2013
- 32
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Pharmaceutical DevelopmentGamlen, Michael / Cummings, Paul et al. | 2013
- 42
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Preclinical Safety TestingMüller, Lutz / Husar, Elisabeth et al. | 2013
- 82
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Exploratory DevelopmentPosner, John et al. | 2013
- 113
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Clinical PharmacokineticsRolan, Paul / Molnár, Valéria et al. | 2013
- 132
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Biological TherapeuticsLloyd, Peter / Sims, Jennifer et al. | 2013
- 143
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Objectives and Design of Clinical TrialsPosner, John / Warrington, Steve et al. | 2013
- 155
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Conduct of Clinical Trials: Good Clinical PracticeDarwin, Kate L. R. et al. | 2013
- 189
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Medical StatisticsGrieve, Andrew P. et al. | 2013
- 219
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Development of Medicines: Full DevelopmentStonier, Peter D. et al. | 2013
- 235
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PharmacovigilanceHobbiger, Stephen F. / Patel, Bina / Swain, Elizabeth et al. | 2013
- 254
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VaccinesBeadle, John et al. | 2013
- 270
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Drugs for CancerSpicer, James / De Bono, Johann et al. | 2013
- 286
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Ethics of Human ExperimentationBarrett, Jane et al. | 2013
- 295
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Drug Development in Paediatrics and NeonatologyMerchant, Nazakat M. / Azzopardi, Denis V. et al. | 2013
- 306
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Due Diligence and the Role of the Pharmaceutical PhysicianBarker, Geoffrey R. et al. | 2013
- 317
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A History of Drug Regulation in the UKGriffin, John P. et al. | 2013
- 347
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The Clinical Trials DirectiveSweeney, Fergus / Raymond, Agnès Saint et al. | 2013
- 360
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Human Medicinal Products in the European Union: Regulations, Directives and StructuresRaymond, Agnès Saint / Humphreys, Anthony J. et al. | 2013
- 379
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Human Medicinal Products in the European Union: ProceduresRaymond, Agnès Saint / Humphreys, Anthony J. et al. | 2013
- 418
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European Regulation of Medical DevicesMason, Shuna et al. | 2013
- 435
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Paediatric RegulationRabe, Heike / Saint‐Raymond, Agnès et al. | 2013
- 447
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Technical Requirements for Registration of Pharmaceuticals for Human Use: The ICH ProcessHarron, Dean W. G. et al. | 2013
- 461
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The Regulation of Drug Products by the US Food and Drug AdministrationHutt, Peter Barton et al. | 2013
- 501
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The US FDA in the Drug Development, Evaluation and Approval ProcessSpivey, Richard N. / Jones, Judith K. / Wardell, William / Vodra, William W. et al. | 2013
- 518
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Future Prospects of the Pharmaceutical Industry and its Regulation in the USASpivey, Richard N. / Vodra, William W. / Jones, Judith K. / Wardell, William et al. | 2013
- 537
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Regulatory and Clinical Trial Systems in JapanSatake, Mamiko / Hosoda, Natsuko et al. | 2013
- 554
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The Regulation of Therapeutic Products in Australiade Somer, Elizabeth / Monk, Deborah / Hirshorn, Janice et al. | 2013
- 587
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An Introduction to Life Cycle Management of MedicinesGillen, David et al. | 2013
- 597
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Availability of Medicines Online and Counterfeit MedicinesDiazaraque, Ruth / Gillen, David et al. | 2013
- 610
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The Supply of Unlicensed Medicines for Individual Patient UseDodds‐Smith, Ian / Townsend, Ewan et al. | 2013
- 632
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Legal and Ethical Issues Relating to Medicinal ProductsBeckett, Nick / Hanson, Sarah / Mason, Shuna et al. | 2013
- 653
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Medical MarketingGalloway, David B. / Thottakam, Bensita M. V. et al. | 2013
- 670
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Information and PromotionDe Wet, Charles et al. | 2013
- 692
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Economics of Health CareBradley, Carole A. / Griffin, Jane R. et al. | 2013
- 707
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Controls on NHS Medicines Prescribing and Expenditure in the UK (a Historical Perspective) with some International ComparisonsGriffin, John P. / Barker, Geoffrey R. et al. | 2013
- 728
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Pharmaceutical Medicine in the Emerging MarketsSreeharan, Nadarajah / Sykes, Jennie A. / Nieman, Richard B. et al. | 2013
- 744
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BiosimilarsHuml, Raymond A. / Posner, John et al. | 2013
- 751
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Appendix 1: Declaration of Helsinki| 2013
- 755
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Appendix 2: Agreements and Guidelines for Implementation of Clinical Trials| 2013
- 771
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Appendix 3: Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001, 771| 2013
- 783
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Appendix 4: PharmaTrain Syllabus 2010| 2013
- 788
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Index| 2013
- i
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Front Matter| 2013