What does SBR mean in STATISTICS

SBR is a specialized field that applies statistical methods to the development and evaluation of biopharmaceuticals, including drugs, biologics, and medical devices. It involves the design and analysis of clinical trials, data management, and statistical modeling to ensure the safety and efficacy of biopharmaceutical products.

SBR plays a crucial role in all phases of clinical trials. It helps researchers design studies that are ethical, efficient, and capable of providing reliable data. Statisticians analyze the data from clinical trials to assess the safety and efficacy of the investigational product, identify potential risks and benefits, and determine whether the product meets regulatory requirements.

SBR ensures that data collected during clinical trials is accurate, complete, and reliable. Statisticians develop data management plans, establish data standards, and implement data collection and storage systems. They also perform data cleaning and validation to ensure the quality of data used for statistical analysis.

SBR utilizes a range of statistical modeling techniques, including:

• Linear and nonlinear regression: Modeling relationships between variables
• Analysis of variance (ANOVA): Comparing multiple groups
• Logistic regression: Predicting the probability of an event
• Survival analysis: Studying time-to-event outcomes
• Bayesian statistics: Incorporating prior knowledge into statistical models

SBR plays a vital role in preparing regulatory submissions to health authorities such as the FDA and EMA. Statisticians provide statistical analyses and reports that demonstrate the safety and efficacy of the investigational product, support the proposed indications and dosage regimens, and address potential safety concerns.