In previous blogs, we’ve examined the statistics behind Non-Compartmental PK/PD analysis. The existence of the Non-Compartmental Analysis (NCA) implies the existence of compartmental analysis, and, indeed, it is among... read more →
In our blog introducing bioequivalence, we described how studies establishing bioequivalence can be a way to avoid expensive clinical trials without compromising on the safety or efficacy of a... 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 →