On Biostatistics and Clinical Trials

For Poisson distribution, there are many different ways for calculating the confidence interval. The paper by Patil and Kulkarni discusses...

To calculate the sample size for a crossover design for bioequivalence study, a key assumption is the intra-subject variation. The intra-su...

In an early article " Cookbook SAS Codes for Bioequivalence Test in 2x2x2 Crossover Design ", I provided the analysis using Proc M...

I am not sure if there is any practical use for sending emails through SAS. But this SAS micro was picked up from RTP SAS User Group Email...

The research triangle area in North Carolina is one of the area with the concentrated talents in statistics and biostatistics. All three bi...

FDA's Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct ou...

Adaptive designs have been more and more commonly used from early phase clinical trials to late phase pivotal clinical trials and from the ...

To meet the requirements by PDUFA V  and FDASIA , FDA organized a public workshop on "Complex Issues in Developing Drug and Biological ...

On Wednesday, January 29, 2014, from 2:00PM - 3:00PM EST, FDA will present a webinar on the final guidance for industry Electronic Source Da...

We all may have difficulties in remembering the drug names and wonder why many drug names are so awkward and difficult to read. For drug ma...

When we conduct a clinical trial using an approved product, we may run into the requests for the list of common, very common adverse events...

This Monday, FDA issued a new guidance titled “ Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA ”. ...