Bruce binkowitz (34 risultati)

hardcover. Condizione: Fine. Open Books is a nonprofit social venture that provides literacy experiences for thousands of readers each year through inspiring programs and creative capitalization of books.

hardcover. Condizione: Like New. Most items will be dispatched the same or the next working day. An apparently unread copy in perfect condition. Dust cover is intact with no nicks or tears. Spine has no signs of creasing. Pages are clean and not marred by notes or folds of any kind.

Paperback. Condizione: New. Brand new book, sourced directly from publisher. Dispatch time is 7-8 days from our warehouse. Book will be sent in robust, secure packaging to ensure it reaches you securely.

Condizione: New.

Condizione: As New. Unread book in perfect condition.

Condizione: New.

Condizione: As New. Unread book in perfect condition.

Paperback / softback. Condizione: New. New copy - Usually dispatched within 4 working days.

Condizione: New.

Paperback. Condizione: New. Global simultaneous development is becoming more necessary as the cost of developing medical products continues to grow. The strategy of using multiregional clinical trials (MRCTs) has become the preferred method for developing new medicines. Implementing the same protocol to include subjects from many geographical regions around the world, MRCTs can speed up the patient enrolment, thus resulting in quicker drug development and obtaining faster approval of the drug globally.After the publication of the editors' first volume on this topic, there have been new developments on MRCTs. The International Council for Harmonisation (ICH) issued ICH E17, a guideline document on MRCTs, in November 2017, laying out principles on MRCTs. Beyond E17, new methodologies have been developed as well.Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17 collects chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. In addition, in contrast to the first book, new perspectives are brought to MRCT from regulatory agencies. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products. It will also be especially helpful for statisticians in regulatory agencies, and medical research institutes.This book is comprehensive across the MRCT topic spectrum, includingIssues regarding ICH E17 ImplementationMRCT Design and Analysis MethodologiesPerspectives from authorities in regulatory agencies, as well as statisticians practicing in the medical product industryMany examples of real-life applications based on actual MRCTs.…

Condizione: As New. Unread book in perfect condition.

Paperback. Condizione: Brand New. 1st edition. 302 pages. 9.50x6.50x0.75 inches. In Stock.

Condizione: New.

hardcover. Condizione: new.

hardcover. Condizione: New. Open Books is a nonprofit social venture that provides literacy experiences for thousands of readers each year through inspiring programs and creative capitalization of books.

paperback. Condizione: New. NEW. SHIPS FROM MULTIPLE LOCATIONS. book.

Hardcover. Condizione: New. Brand new book, sourced directly from publisher. Dispatch time is 7-8 days from our warehouse. Book will be sent in robust, secure packaging to ensure it reaches you securely.

Paperback. Condizione: New. Global simultaneous development is becoming more necessary as the cost of developing medical products continues to grow. The strategy of using multiregional clinical trials (MRCTs) has become the preferred method for developing new medicines. Implementing the same protocol to include subjects from many geographical regions around the world, MRCTs can speed up the patient enrolment, thus resulting in quicker drug development and obtaining faster approval of the drug globally.After the publication of the editors' first volume on this topic, there have been new developments on MRCTs. The International Council for Harmonisation (ICH) issued ICH E17, a guideline document on MRCTs, in November 2017, laying out principles on MRCTs. Beyond E17, new methodologies have been developed as well.Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17 collects chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. In addition, in contrast to the first book, new perspectives are brought to MRCT from regulatory agencies. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products. It will also be especially helpful for statisticians in regulatory agencies, and medical research institutes.This book is comprehensive across the MRCT topic spectrum, includingIssues regarding ICH E17 ImplementationMRCT Design and Analysis MethodologiesPerspectives from authorities in regulatory agencies, as well as statisticians practicing in the medical product industryMany examples of real-life applications based on actual MRCTs.…

Condizione: New.

Condizione: As New. Unread book in perfect condition.

Condizione: New.

Condizione: New. 1st edition NO-PA16APR2015-KAP.

Condizione: New.

Condizione: New.

Hardback. Condizione: New. New copy - Usually dispatched within 4 working days.

Hardcover. Condizione: Brand New. 1st edition. 302 pages. 9.75x6.50x0.75 inches. In Stock.

PAP. Condizione: New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.

PAP. Condizione: New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.

Condizione: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Dr. Gang Li is Senior Director, Real World Evidence (RWE) and Medical Value, the Neurology Business Group of Eisai Inc. He received his PhD in Mathematical Statistics from the State University of New York at Binghamton. He co-authored ov.…

Taschenbuch. Condizione: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - This book contains chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products.…