1. |
News |
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International Journal of Pharmaceutical Medicine,
Volume 18,
Issue 1,
2004,
Page 1-1
&NA;,
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ISSN:1364-9027
出版商:ADIS
年代:2004
数据来源: ADIS
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2. |
The European Clinical Trials Directive: Will it Promote Clinical Research in Europe? |
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International Journal of Pharmaceutical Medicine,
Volume 18,
Issue 1,
2004,
Page 3-3
Richard Tiner,
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ISSN:1364-9027
出版商:ADIS
年代:2004
数据来源: ADIS
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3. |
Impact of the Clinical Trials Directive on the Research-Based Pharmaceutical Industry |
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International Journal of Pharmaceutical Medicine,
Volume 18,
Issue 1,
2004,
Page 5-8
Moira Daniels,
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ISSN:1364-9027
出版商:ADIS
年代:2004
数据来源: ADIS
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4. |
Directive 2001/20/EC on Good Clinical Practice in Clinical TrialsOverview with Reference to Pharmacovigilance |
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International Journal of Pharmaceutical Medicine,
Volume 18,
Issue 1,
2004,
Page 9-12
Joy I. Chukwujindu,
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ISSN:1364-9027
出版商:ADIS
年代:2004
数据来源: ADIS
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5. |
Releasing the Human Spirit in Developing DrugsIncreasing Clinical Pharmacokinetics Productivity |
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International Journal of Pharmaceutical Medicine,
Volume 18,
Issue 1,
2004,
Page 13-17
J Robert Powell,
Edward J. Randinitis,
Jack A. Cook,
Richard L. Lalonde,
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摘要:
A common problem in drug development is that highly trained people become trapped in doing the work of their respective discipline without taking individual responsibility for the most important questions. ‘Getting the dosage regimen right’ is a fundamental problem in drug development that is often not well performed. The experience described here transformed a department from completing required clinical pharmacokinetic studies to focusing on the most important questions in dosage regimen design that did not have a unique solution. Elements of the story include vision, quality, best practice, automation, transformation and impact. Productivity was increased by 81% within 2 years by one measure and there was a substantial positive financial impact.
ISSN:1364-9027
出版商:ADIS
年代:2004
数据来源: ADIS
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6. |
The Changing European Regulatory LandscapePresent and Future Challenges to the Development of Biotechnological and Emerging Technology Products |
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International Journal of Pharmaceutical Medicine,
Volume 18,
Issue 1,
2004,
Page 19-29
Lincoln Tsang,
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摘要:
Whilst the US has traditionally been considered the Agency that sets the gold standard for medicines regulation, with the increasing demand for global cooperation and harmonisation of technical conformity and regulatory control, consideration should be given to regulatory requirements in jurisdictions other than the US. The European Union is becoming an important region for global product development. This review sets out scientific and public policy aspects that underpin the European legislative framework for certain healthcare products, including those derived from novel technological platforms. This review attempts to highlight some of the current and new challenges to the development of biotechnological and emerging technology products. There seems little doubt that the whole area of regulatory laws and policy will present new challenges to companies and their advisors in the coming years.It should be recognised that the development of high technology products is more costly and carries higher business risks compared with conventional pharmaceutical products. A successful product development should therefore be underpinned by not only good science, but a thorough understanding of the regulatory environment, which is increasingly complex. The development programme should integrate regulatory strategy at the early stages. This will help identify, address and manage potential regulatory risks that will greatly facilitate the progress of research and development, and the timeliness of the commercial launch of a product.
ISSN:1364-9027
出版商:ADIS
年代:2004
数据来源: ADIS
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7. |
First Reports of Adverse Drug Reactions (ADRs) in Recent Weeks |
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International Journal of Pharmaceutical Medicine,
Volume 18,
Issue 1,
2004,
Page 31-37
&NA;,
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ISSN:1364-9027
出版商:ADIS
年代:2004
数据来源: ADIS
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8. |
Summary of Recent Deal ActivitiesDrug Discovery Technologies |
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International Journal of Pharmaceutical Medicine,
Volume 18,
Issue 1,
2004,
Page 39-46
&NA;,
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PDF (136KB)
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ISSN:1364-9027
出版商:ADIS
年代:2004
数据来源: ADIS
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9. |
New in the Marketplace |
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International Journal of Pharmaceutical Medicine,
Volume 18,
Issue 1,
2004,
Page 47-47
&NA;,
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PDF (117KB)
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ISSN:1364-9027
出版商:ADIS
年代:2004
数据来源: ADIS
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10. |
SPM News |
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International Journal of Pharmaceutical Medicine,
Volume 18,
Issue 1,
2004,
Page 49-58
&NA;,
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PDF (221KB)
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ISSN:1364-9027
出版商:ADIS
年代:2004
数据来源: ADIS
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