We offer pharmacometrics services that will help our clients to address their key drug development. We have a wide experience in different areas including Non-Compartmental Analysis (NCA's). Compartmental Analysis, Population PK analysis, Physiologically PK analysis (PBPK), PK/PD, IVIC, Modelling and Simulation.

According to the FDA Division of Pharmacometrics, pharmacometrics is an emerging science defined as the science that quantifies drug, disease and trial information to aid efficient drug development and/or regulatory decisions. Drug models describe the relationship between exposure (or pharmacokinetics), response (or pharmacodynamics) for both desired and undesired effects, and individual patient characteristics. Disease models describe the relationship between biomarkers and clinical outcomes, time course of disease and placebo effects. The trial models describe the inclusion/exclusion criteria, patient dis-continuation and adherence.

We have expertise in all these models and for special populations including pediatric populations.  We use : concentration-effect, dose-response, PKPD relationships to support your drug development process  at any stage of the pipeline.

We can perform  compartmental and non-compartmental PK analysis including performing  interim PK analyses to inform dosing, Design/analyze dataset specifications using several  PK software packages that meet your needs including   (NONMEM for population PK , PHEONIX WINNONLIN/NLME  for non compartmental analysis, PK/PD, compartmental Analysis , PKSIM for physiologically based modelling [PBPK]).  

We can use any of these software to help you with dose selection/optimization at any stage of the trail process, identify mechanism of action, model probability of adverse effects (AE's)   as function of exposure (and covariates)

Children differ from adults in their response to drugs. While this may be the result of changes in dose exposure (pharmacokinetics [PK]) and/or exposure response (pharmacodynamics [PD]) relationships, the magnitude of these changes may not be solely reflected by differences in body weight. 

As a consequence, dosing recommendations empirically derived from adults dosing regimens using linear extrapolations based on body weight, can result in therapeutic failure, occurrence of adverse effect or even fatalities. In order to define rational, patient-tailored dosing schemes, population PK–PD studies in children are needed. 

We use population modelling using to analysis of sparse, opportunistic and unbalanced datasets from pediatric populations (preterm, neonates, infants and older children). Additionally we are able to  explore the influence of different covariates such as body weight and age to explain the variability in drug response.

We use several approaches to to obtain the maximum information on the PK–PD parameters with the highest precision. The goals is to improve the efficacy/safety balance of dosing guidelines, which will be of benefit to the individual child.

 We provide seminars and training programs can be uniquely designed to meet your specific Company needs (bioanalytical analysis, pharmacometrics, pharmacokinetics ).  Additional services may also be available upon request, contact us for additional details.