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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 second
of the 3-volume book series. The topics covered include:
Statistical Approaches to the Meta-analysis of Randomized Clinical
Trials, Collaborative Targeted Maximum Likelihood Estimation to
Assess Causal Effects in Observational Studies, Generalized Tests
in Clinical Trials, Discrete Time-to-event and Score-based Methods
with Application to Composite Endpoint for Assessing Evidence of
Disease Activity-Free , Imputing Missing Data Using a Surrogate
Biomarker: Analyzing the Incidence of Endometrial Hyperplasia,
Selected Statistical Issues in Patient-reported Outcomes, Network
Meta-analysis, Detecting Safety Signals Among Adverse Events in
Clinical Trials, Applied Meta-analysis Using R, Treatment of
Missing Data in Comparative Effectiveness Research, Causal
Estimands: A Common Language for Missing Data, Bayesian Subgroup
Analysis with Examples, Statistical Methods in Diagnostic Devices,
A Question-Based Approach to the Analysis of Safety Data, Analysis
of Two-stage Adaptive Seamless Trial Design, and Multiplicity
Problems in Clinical Trials - A Regulatory Perspective.
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 Other Data Quality Issues in Clinical Trials,
Development and Evaluation of High Dimensional Prognostic Models,
and Design and Analysis of Biosimilar Studies.
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 Other Data Quality Issues in Clinical Trials,
Development and Evaluation of High Dimensional Prognostic Models,
and Design and Analysis of Biosimilar Studies.
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 second
of the 3-volume book series. The topics covered include:
Statistical Approaches to the Meta-analysis of Randomized Clinical
Trials, Collaborative Targeted Maximum Likelihood Estimation to
Assess Causal Effects in Observational Studies, Generalized Tests
in Clinical Trials, Discrete Time-to-event and Score-based Methods
with Application to Composite Endpoint for Assessing Evidence of
Disease Activity-Free , Imputing Missing Data Using a Surrogate
Biomarker: Analyzing the Incidence of Endometrial Hyperplasia,
Selected Statistical Issues in Patient-reported Outcomes, Network
Meta-analysis, Detecting Safety Signals Among Adverse Events in
Clinical Trials, Applied Meta-analysis Using R, Treatment of
Missing Data in Comparative Effectiveness Research, Causal
Estimands: A Common Language for Missing Data, Bayesian Subgroup
Analysis with Examples, Statistical Methods in Diagnostic Devices,
A Question-Based Approach to the Analysis of Safety Data, Analysis
of Two-stage Adaptive Seamless Trial Design, and Multiplicity
Problems in Clinical Trials - A Regulatory Perspective.
The Small Think Big Book offers unique insights, inspirational
stories, and actionable ideas to help small businesses thrive in a
hyper-connected market place. From creating an on-line presence to
harnessing the power of data, the authors show how small businesses
today are using the web to win.
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