On Biostatistics and Clinical Trials

Biosimilars or Follow-on biologics are terms used to describe officially approved new versions of innovator biopharmaceutical products, fo...

I have been thought that the chinese traditional medicine from herbal is typically safe. However, recent discussions with my friends make me...

Sub-grouping damages the balance obtained by randomization If the randomization is stratified for one factor (for example, disease severity)...

The following annoucement really makes sense. Previously, FDA could issue an "approvable" letter that could be very confusing. A p...

In an article by Willke et al (Controlled Clinical Trials, 25, 2004), the study endpoints were classified as three major categories. Endpoin...

The newly released Declaration of Helsinki was issued by the 59th World Medical Association General Assembly in October 2008. This document ...

Words that end up in court Altered records, defect, falsification, hazardous, illegal, incompetence, inferior, negligent, reckless, wrongdoi...

One of my friends asked me what would be the source data and how to verify if the data was directly entered into EDC. A recent article in cl...

The recent effort to standardize the clinical data acquisition results in a lot of new acronyms . Some of them are listed below. A lot of th...

Training & Resources: Acrobat for life sciences blog - http://blogs.adobe.com/acrobatforlifesciences/ Acrobat legal links online - https...

The book by Drs Tozer and Rowland is pretty good. About dose "To paraphrase Paracelsus, who lived some 500 years ago, "all drugs a...

Target Product Profile (TPP) is a new concept to me. However, it may not be a new term at all. Recently, I was asked to review a TPP and I s...

In biological field, it is pretty common to collect and analyze the adverse events that are temporally associated with an infusion. For exam...

Typically, the physicians will listen to statisticians for statistical analysis approaches. In some cases, the physicians can be very smart ...

Four rules to adapt by: Allocation rule: how subjects will be allocated to the avaialble arms Sampling rule: how many subjects will be sam...

A recent article by Mr Getz in Applied Clinical Trials elaborated the heavy burden of protocol design in modern clinical trials. The clinica...

My fellow colleague expressed his frustration about exlaining a statistical concept to our clinical operation colleagues. I fully undertood ...

Rule of three states that consider a Bernoulli random variable with unknown probability p, if in n independent trials no events occur, a qui...

In regulatory setting, can we showing the treatment difference by comparing the slopes between two treatment groups? In a COPD study (e.g., ...

In bioavailability and bioequivalence studies, the pharmacokinetic parameters ( AUC , Cmax ) are often assumed to follow the log normal d...