Use Your Pharmacokinetic Analysis Results to Optimize Your Drug Development

Online, October 24, 2013 (Newswire.com) - What is a Pharmacokinetic analysis? Go back to the basics: pharmacokinetic is the science which allows to study the future of a molecule in the organism: it studies absorption, distribution, metabolism and finally excretion. In the context of a drug development, it is absolutely necessary to run this type of analysis during preclinical studies (animal testing) and clinical trials (human testing). However, it is important to know that pharmacokinetic studies bring substantially more.

At PhinC Development, we have a broad enough scope to cover any of PK analysis requirements, including: bioequivalence studies, drug-to-drug interactions, food interactions, etc. Calculations of PK parameters are performed according to standard international definitions, then followed by an in-depth interpretation.

However, it is not enough: it turns out that information provided by PK data can also be used to run Modeling and Simulations as a supportive method from the early phases to lead drug development in a smarter way. Indeed, starting from pharmacokinetic data, Modeling & Simulation techniques allows to build a structural model which is used to simulate necessary doses to reach the expected exposure or effect on the organism. Results of those simulations are key to design appropriately the next clinical study. It can avoid unnecessary tests and so, participate to drug development optimization in time and money. Using pharmacokinetic analysis combined to Modeling & Simulation, PK Population analysis, PK/PD analysis and more generally pharmacometrics is the foundation of Model-Based Drug Development (MBDD) concept.

Pharmacometrics have been highly supported by the FDA and the EMA a long time ago, but the use of these techniques are just been recognized has powerful tools to drive the drug development since the early phases. PhinC Development is one of the few companies in Europe to promote and concretely apply pharmacometrics in early drug development in order to help sponsors to improve their drug development since discovery and preclinical phases.

PhinC Development multidisciplinary team of experts uses modeling & simulation, predictive tools and powerful statistic methods to adapt and optimize each study at each step (iterative process) without forgetting the objectives of the trial. PhinC Development experts have more than 20 years of experience in clinical pharmacology, pharmacokinetics, biostatistics and early stage development in a wide range of therapeutic areas. Whether it be for punctual problem solving or for long term support, PhinC Development services allow sponsors to significantly save time in their drug development.