PK/PD & Biostatistics

Trust the PK/PD and statistics experts to help you navigate through your clinical data.

Biostatistics

ARI’s Biostatistics department can assist the sponsor in the design, analysis and interpretation of study data from First-in-man to Phase IV. Our expert biostatisticians have broad experience in various aspects of clinical trials within the drug development arena, from sample size calculation and design issues at the planning stage, to analyzing, displaying and interpreting data in the final stages of the study.

ARI’s Biostatistics department comprises of senior biostatisticians and SAS programmers who are specialists in designing a statistical analysis plan that carefully and clearly details all of the statistical analyses that will be performed for your study. Following study conduct, the biostatistics group will provide statistical summaries, efficacy and safety analyses while ensuring fast turnaround times and accurate results.

The PK/PD and Biostatistics department at ARI are involved in the study from the initial stages right through to final report. They ensure that the study design and statistical plan are created to answer the study objectives. During the studies they are actively involved in all safety discussions to provide input as needed.

Pharmacokinetic/Pharmacodynamic Analysis

ARI’s PK/PD group has the experience to guide and assist you in any type of PK/PD analyses from pre-clinical to phase IV studies. Our experts use both noncompartmental and compartmental techniques from an individual and population perspective in order to:

  • Enhance understanding of pre-clinical data from both an efficacy and toxicity standpoint. We predict the PK of the compound in humans, as well as estimate First-in-man dose ranges.
  • Go beyond the traditional methods of analyzing and presenting Phase I data to allow proof of concept studies be completed within Phase I. This allows the sponsor to make pivotal decisions on dosing regimens for Phase II and III studies.
  • Assess all formulation options of the active ingredient and assist sponsor in deciding whether pilot studies are necessary, and/or whether the formulation has the potential to be bioequivalent.
  • Correctly determine and assess the PK/PD of your compound from all possible study designs from a population perspective.
  • Simulate and predict the efficacy and toxicity of different dosing regimens using Monte-Carlo techniques.
  • Design optimal sampling strategy for Phase II and III studies.
  • Perform diverse in vitro / in vivo correlation techniques (IVIVC).

ARI’s pharmacokineticists, pharmacometricians and clinical pharmacology experts have experience in using a vast variety of tools and software applications including WinNonlin® and SAS® for noncompartmental analyses, ADAPT-II® for individual compartmental analyses, and NONMEM® and IT2S® for population compartmental analyses.

Lost in the numbers? Find answers by contacting us today.