Statistical Issues in Drug Development
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(37)- Epistemology of causal inference in pharmacology, Towards a framework for the assessment of harms
- Optimal designs for dose-escalation trials and individual allocations in cohorts
- End-to-end drug supply management in multicenter trials
- Optimal approximate designs for comparison with control in dose-escalation studies
- Confidence intervals for dependent data: equating non-overlap with statistical significance
- Predictive Hierarchic Modeling of Operational Characteristics in Clinical Trials
- Biosimilars. Design and analysis of follow-on biologics
- Theory of drug development
- Statistical modeling of clinical trials (Recruitment and randomization)
- scientific article; zbMATH DE number 5946617 (Why is no real title available?)
- Statistical Methods for Dose‐Finding Experiments
- GROUP SEQUENTIAL TESTS WITH OUTCOME-DEPENDENT TREATMENT ASSIGNMENT
- Phase I (or Phase II) Dose-Ranging Clinical Trials: Proposal of a Two-Stage Bayesian Design
- Nonclinical statistics for pharmaceutical and biotechnology industries
- Drug discovery
- E- and R-optimality of block designs for treatment-control comparisons
- Simulation of clinical trials: a review with emphasis on the design issues
- scientific article; zbMATH DE number 2201812 (Why is no real title available?)
- Proportional hazards models with random effects to examine centre effects in multicentre cancer clinical trials
- The design of multicentre trials
- The design of multicentre trials
- Basic statistics and pharmaceutical statistical applications.
- A Five-Decision Testing Procedure to Infer the Value of a Unidimensional Parameter
- Friction and Decision Rules in Portfolio Decision Analysis
- Statistical issues in the drug evaluation process: some issues in applying the ICH guidelines
- Recruitment prediction for multicenter clinical trials based on a hierarchical Poisson–gamma model: Asymptotic analysis and improved intervals
- The assessment of replication success based on relative effect size
- Beyond the two-trials rule: Type-I error control and sample size planning with the sceptical $p$-value
- A tutorial on individualized treatment effect prediction from randomized trials with a binary endpoint
- Two-tailed significance tests for 2 2 contingency tables: what is the alternative?
- Confidence bounds for nonlinear dose-response relationships
- Variance reduction in randomised trials by inverse probability weighting using the propensity score
- A note regarding `random effects'
- A regulatory perspective on missing data in the aftermath of the NRC report
- Mastering variation: variance components and personalised medicine
- Seven myths of randomisation in clinical trials
- Supplementation of a clinical trial by historical control data: is the prospect of dynamic borrowing an illusion?
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