KJC Statistics is proud to be part of the Kidney Health Initiative. The aim of the KHI is to “advance…
Novel, adaptive designs are seen by many drug developers as highly attractive as they seemingly offer more for less: more…
FDA reviews the learning from 22 case studies. Despite what are often reported as promising phase II data, the subsequent…
As if justifying one wasn’t tough enough…now Sponsor have two non-inferiority margins to deal with?! Dealing with FDA’s new guidance…
KJC statistics is pleased to announce a working collaboration with Ms Claire Watkins, MSc, of ClaroStat Consulting. Claire has over…
KJC Statistics will be attending Kidney Week 2016 in Chicago. Kidney Week, which takes place from the 15th – 20th…
KJC statistics is pleased to announce the commencement of a formal collaboration with Mr Aaron Dane, MSc, CStat, of DaneStat…
In standard bioequivalence assessment, typically the pharmacokinetic characteristics of a single batch of a reference product is compared to a…
Most people involved in drug development have heard of surrogate endpoints and many continue to argue that they are needed…
