Biopharmaceutical Applied Statistics Symposium

Volume 3 Pharmaceutical Applications

Karl E. Peace, Ding-Geng Chen, Sandeep Menon (Herausgeber)

Buch | Hardcover

426 Seiten

2018 | 1st ed. 2018
Springer Verlag, Singapore
978-981-10-7819-4 (ISBN)

Artikel merken

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter.
The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications.

This book is the third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and OtherData Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.

Part I: Personalized Medicine.- 1 Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints.- 2 Uses of Mixture Normal Distribution in Genomics and Otherwise.- 3 Personalized Medicine – Design Considerations.- 4 Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials.- 5 High Dimensional Data in Genomics.- Part II: Novel Applications.- 6 Synergy or Additivity - The Importance of Defining the Primary Endpoint.- 7 Full Bayesian Adaptive Dose Finding using Toxicity Probability Interval (TPI).- 8 Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials.- 9 Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals.- 1 Clinical Trials in Orphan Drug Development.- 11 Mediation Modeling in Randomized Trials with Non-normal Outcome Variables.- 12 Statistical Considerations in Using Images in Clinical Trials.- 13 Interesting Applications over 30 Years of Consulting.- 14 Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials.- 15 Development and Evaluation of High Dimensional Prognostic Models.- 16 Design and Analysis of Biosimilar Studies.

Erscheinungsdatum	09.04.2018
Reihe/Serie	ICSA Book Series in Statistics
Zusatzinfo	46 Illustrations, color; 28 Illustrations, black and white; XV, 426 p. 74 illus., 46 illus. in color.
Verlagsort	Singapore
Sprache	englisch
Maße	155 x 235 mm
Themenwelt	Mathematik / Informatik ► Mathematik ► Statistik
	Mathematik / Informatik ► Mathematik ► Wahrscheinlichkeit / Kombinatorik
	Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie
	Naturwissenschaften ► Biologie
Schlagworte	Alpha-recycling • Carcinogenicity Studies • Clinical Trials • Defining the Primary Endpoint • genomics • Mixture Normal Distribution • Optimal Individualized Treatment Rules • Personalized medicine • Phase III Oncology Genomics Trials • Toxicity Probability Interval
ISBN-10	981-10-7819-X / 981107819X
ISBN-13	978-981-10-7819-4 / 9789811078194
Zustand	Neuware