Birol Emir's Books

Interface between Regulation and Statistics in Drug Development

By: Demissie Alemayehu,Birol Emir,Michael Gaffney

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Interface between Regulation and Statistics in Drug Development

By: Demissie Alemayehu,Birol Emir,Michael Gaffney

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors’ decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.

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Page Count

173

Publisher

CRC Press

Published Date

ISBN 10

1000215709

ISBN 13

9781000215700

Turkey and Qatar in the Tangled Geopolitics of the Middle East

By: Birol Başkan

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Turkey and Qatar in the Tangled Geopolitics of the Middle East

By: Birol Başkan

This book narrates how Turkey and Qatar have come to forge a mutually special relationship. The book argues that throughout the 2000s Turkey and Qatar had pursued similar foreign policies and aligned their positions on many critical and controversial issues. By doing so, however, they increasingly isolated themselves in the Middle East as states challenging the status quo. The claim made here is that it is this isolation—which became acute in the summer of 2013—that led the two countries to forge much stronger relations.

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Page Count

153

Publisher

Springer

Published Date

ISBN 10

1137517719

ISBN 13

9781137517715

The Emerging European Union

By: Birol Yesilada

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The Emerging European Union

By: Birol Yesilada

Surveying the European Union's evolution from the Rome Treaty to the present, The Emerging European Union captures the full story of Europe's ongoing integration, its changing identity, and its increasing importance as a global actor in the 21st Century. This text's concise but comprehensive overview of the history, institutions, and policies of the European Union lays out the major elements of the European integration and explain how the European Union functions. Emphasizing competing intergovernmental and supranational forces, The Emerging European Union explains the origins and future of the European Union as well as its political uniqueness.

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Page Count

257

Publisher

Routledge

Published Date

ISBN 10

1317343409

ISBN 13

9781317343400

Interface between Regulation and Statistics in Drug Development

By: Demissie Alemayehu,Birol Emir,Michael Gaffney

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Interface between Regulation and Statistics in Drug Development

By: Demissie Alemayehu,Birol Emir,Michael Gaffney

Average ratings

N/A

Write a review

Solve jigsaw puzzle

Age

Page Count

173

Publisher

CRC Press

Published Date

ISBN 10

1000215709

ISBN 13

9781000215700

Book's by Birol Emir

Interface between Regulation and Statistics in Drug Development

Interface between Regulation and Statistics in Drug Development

Turkey and Qatar in the Tangled Geopolitics of the Middle East

Turkey and Qatar in the Tangled Geopolitics of the Middle East

The Emerging European Union

The Emerging European Union

Interface between Regulation and Statistics in Drug Development

Interface between Regulation and Statistics in Drug Development

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