Drug Regulator FDA, Publishes Guidance on the Use of Bayesian Statistics in Medical Device Clinical Trials
Full Text Here
This document provides guidance on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistical methods.
The purpose of this guidance is to discuss important statistical issues in Bayesian clinical trials for medical devices. The purpose is not to describe the content of a medical device submission. Further, while this document provides guidance on many of the statistical issues that arise in Bayesian clinical trials, it is not intended to be all-inclusive. The statistical literature is rich with books and papers on Bayesian theory and methods; a selected bibliography has been included for further discussion of specific topics.
Click Here – Regulatory Services – Click Here
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
