Our Subject Volunteers are the most important part of our Clinical Trials and without them, there is no data. Without good, quality data, there is no accurate statistical analysis. So, how do we ensure the data we collect are quality data that we can use in clinical...

This article is prepared to provide an overview of suggested steps to take prior to and during an FDA GCP Inspection of a Clinical Research Organization to achieve success. TYPE OF FDA INSPECTIONS FDA conducts several types of inspections routinely to assist in the...

Repeated measures design has been widely used in the early phase hap study, such as the two-way crossover design for a regular Bioequivalence study. Since the same subjects receive multiple measures, one obvious advantage of the repeated measures design is that fewer...

Abstract: In this paper, a few properties of logarithmic and exponential functions will be reviewed by presenting problems arising from real studies. The properties are presented under 3 topics. Introduction The logarithmic (ln) and the exponential (exp) functions are...

A drug-drug interaction (DDI) is a reaction between two (or more) drugs. A DDI can have pharmacology effect and Pharmacokinetic (PK) effect. The pharmacological effect of one or both drugs may be increased or decreased, or a new and unanticipated adverse effect may be...