Validation of statistical software is required for use in regulatory work. Many auditors expect to see the traditional IQ, OQ, PQ approach applied to the base system (SAS, R,... read more →
Blogs
A common discussion we at Quantics have with our clients surrounds the issue of pseudo-replicates. It’s an area of tension between scientist and statistician – pseudo-replicates reduce the cost... read more →
The United States Pharmacopeia (USP) guidance on biological assay validation, General Chapter <1033>, will soon be updated. In the leadup to the publication of the new guidance,... read more →
Validation of statistical software is required for use in regulatory work. Many auditors expect to see the traditional IQ, OQ, PQ approach applied to the base system (SAS, R,... read more →
One of the greatest challenges in the development of new drugs and therapeutics is that it’s just plain expensive. The average spend on a drug which passes clinical trial... read more →
Crucial in understanding the safety and efficacy of a drug are how it percolates through the body, or pharmacokinetics (PK), and how the body responds to its presence,... read more →
Validation of statistical software is required for use in regulatory work. Many auditors expect to see the traditional IQ, OQ, PQ approach applied to the base system (SAS, R,... read more →
A common discussion we at Quantics have with our clients surrounds the issue of pseudo-replicates. It’s an area of tension between scientist and statistician – pseudo-replicates reduce the cost... read more →
The United States Pharmacopeia (USP) guidance on biological assay validation, General Chapter <1033>, will soon be updated. In the leadup to the publication of the new guidance,... read more →
Population Pharmacokinetics (PopPK) is the gold standard method of understanding drug safety and efficacy, particularly as it provides a unique insight into the variation of drug behaviour from person... read more →
This is the third blog in our trilogy on techniques for population adjustment in network meta-analysis (NMA). Here we will focus on an approach called Multi-Level Network Meta-Regression (ML-NMR),... read more →
In this blog we will describe an alternative approach to indirect comparison - Simulated Treatment Comparison (STC) and discuss the key aspects to consider when looking to use the... read more →
Unless you’ve been hiding under a rock for the past few months (and, honestly, who could blame you), you will have interacted with artificial intelligence (AI) in some form.... read more →
When James Lind (of Edinburgh, no less) first tested vitamin C as a cure for scurvy in 1747, he happened upon an experiment design which has persisted to this... read more →
Designing and running a clinical trial for a medical device is expensive, and to avoid wasting money, time and risking the validity of the trial, it is important to get... read more →
In a previous blog, we looked at fitting dose-response models to quantal data in ecotoxicology scenarios. To recap, quantal data refers to data where the response variable takes a binary... read more →
Recently our team at Quantics were working on an analysis for an ecotoxicology client which called for us to use the Jonckheere-Terpstra test for ordered differences which is recommended... read more →
In ecotoxicology statistics there are three main types of data: continuous discrete quantal / binary Continuous data is that which can take a (numerical) value over a continuous range (e.g.... read more →