Drug compounding, in the context of Phase 1 and early-phase drug development, is the process of preparing customized investigational drug formulations from individual ingredients or components. During these early stages of drug development, the pharmaceutical compound...
One of the unique characteristics of human beings is our urge to go beyond the limits set for us by our environment. Science is one of the tools that humans use to achieve this goal. In 1968, Malcolm Dole reported unusual ion current traces after atmospheric pressure...
Abstract: In this paper, we provide a brief review of conventional ANOVA and its counterpart mixed model. We provide a comparison of the two models and briefly discuss the models recommended by the agencies. Analysis of Variance, also known as ANOVA, is one of the...
First-in-human (FIH) studies are a critical step in the development of new therapeutic interventions, providing the initial opportunity to assess their safety, tolerability, and pharmacokinetics in humans. However, these studies can pose various challenges and risks,...
An Introduction to Multiple-dose Study Dose and dose regimen are some of the features that need to be determined first when designing a clinical trial for an investigational product (IP). While providing a single dose of study drug is often facilitated to quickly...
Who is the Standards Council of Canada (SCC)? The Standards Council of Canada (SCC) is a Crown corporation established by an act of the Canadian Parliament in 1970 to foster and promote voluntary standardization in Canada. Good Laboratory Practice (GLP) accreditation...
