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Statistical Methods in Biomarker and Early Clinical Development by Liang Fang
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Artikelmerkmale
- Artikelzustand
- Book Title
- Statistical Methods in Biomarker and Early Clinical Development
- Publication Date
- 2019-12-27
- Pages
- 348
- ISBN
- 9783030315023
Über dieses Produkt
Product Identifiers
Publisher
Springer International Publishing A&G
ISBN-10
3030315029
ISBN-13
9783030315023
eBay Product ID (ePID)
26038552665
Product Key Features
Number of Pages
Xii, 348 Pages
Publication Name
Statistical Methods in Biomarker and Early Clinical Development
Language
English
Subject
Biostatistics, Applied
Publication Year
2019
Type
Textbook
Subject Area
Mathematics, Medical
Format
Hardcover
Dimensions
Item Weight
24.9 Oz
Item Length
9.3 in
Item Width
6.1 in
Additional Product Features
Number of Volumes
1 vol.
Illustrated
Yes
Table Of Content
Predictive Subgroup/Biomarker Identification and Machine Learning Methods.- Characterize and Dichotomize a Continuous Biomarker.- Surrogate Biomarkers.- Innovative Designs for Biomarker Guided Trials.- Statistical Considerations in the Development of Companion Diagnostic Device.- Biomarker Assay Development, Qualification and Validation.- Validation of Genomic Based Assay.- Clinical Application of Molecular Features in Therapeutic Selection and Drug Development.- Big data, real-world data, and machine learning.- Design and Analysis of Clinical Pharmacology Studies.- Statistical Considerations in Proof of Concept Studies.- Safety in Early Phase Studies.- Statistical Evaluation of QT/QTc Interval Prolongation.- Phase II Dose Finding.- Pharmacometrics.
Synopsis
Predictive Subgroup/Biomarker Identification and Machine Learning Methods.- Characterize and Dichotomize a Continuous Biomarker.- Surrogate Biomarkers.- Innovative Designs for Biomarker Guided Trials.- Statistical Considerations in the Development of Companion Diagnostic Device.- Biomarker Assay Development, Qualification and Validation.- Validation of Genomic Based Assay.- Clinical Application of Molecular Features in Therapeutic Selection and Drug Development.- Big data, real-world data, and machine learning.- Design and Analysis of Clinical Pharmacology Studies.- Statistical Considerations in Proof of Concept Studies.- Safety in Early Phase Studies.- Statistical Evaluation of QT/QTc Interval Prolongation.- Phase II Dose Finding.- Pharmacometrics., This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.
LC Classification Number
QH323.5
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AlibrisBooks
98,6% positive Bewertungen•1.9 Mio. Artikel verkauft
Angemeldet als gewerblicher Verkäufer
Verkäuferbewertungen (513'670)
- n***g (383)- Bewertung vom Käufer.Letzter MonatBestätigter KaufThe book is in great condition. and as described. Great seller, fast shipping. Thank you!
- d***1 (25)- Bewertung vom Käufer.Letzter MonatBestätigter KaufSeller did not send the right book, possibly on purpose, and has not issued my refund yet
- a***2 (140)- Bewertung vom Käufer.Letzter MonatBestätigter KaufIt’s perfect 😍!!! Thank you.