Statistical Intervals
Confidence Interval
Process Validation
Life Science Consulting
Aug 15, 2013 12:00:00 AM
Understanding Statistical Intervals: Part 2 - Prediction Intervals
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
General Regulatory
Drug Approval
Regulatory Sciences
Mar 29, 2022 12:00:00 AM
FDA’s Expedited Programs Explained
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Biostatistics
Clinical Research Solutions
Dec 22, 2020 12:00:00 AM
How Important is Biostatistics?
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
ICH
MW
QC
CSR
Clinical Research Solutions
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Dec 8, 2020 12:00:00 AM
A Guide to the Clinical Study Report
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
General Regulatory
FDA Meetings
Regulatory Sciences
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Feb 28, 2017 12:00:00 AM
Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products
On March 10, 2015, the FDA published a draft guidance, providing a number of recommendations regarding the conduct of formal meetings between the FDA and Sponsors. These meetings are intended to...
Regulatory Sciences
Oct 12, 2022 12:00:00 AM
Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings: A New Mechanism for Interacting with FDA
For those who have been awaiting Congressional reauthorization of PDUFA, the wait is over. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. We...
