skip to Main Content
(919) 657-0660

Analyze. Design. Optimize.

Pharmacokinetic (PK) modeling is a powerful and cost-effective tool for developing, optimizing and de-risking clinical trial designs.

Our team of pharmacokineticists/modelers use sophisticated software such as WinNonLin® and GastroPlus® as well as internally developed tools to generate multi-compartmental predictive models of in vivo drug release, absorption, distribution, metabolism, and excretion.

The goals of these models are to:

  • Predict clinical outcomes from animal data that go beyond allometric scaling
  • Assess outcomes of different dosing regimens
  • Identify the dosing regimen most likely to provide the desired plasma concentration profile
  • Predict outcomes with other release profiles, dosing regimens, and even in different species

Determining the Optimal Dosing Regimen

When we observe non-linear PK, very rapid clearance or significant accumulation in preclinical or early clinical studies, we use predictive PK modeling to evaluate dosing paradigms and determine what is most likely to work and what isn’t. This goes a long way toward de-risking the program and may result in significant cost and time savings.

Designing CR Dosage Forms

Zero-order release is not always the ideal profile for a CR dosage form. With predictive PK modeling, we work backward from the target plasma profile to generate an ideal release profile that becomes our target for formulation development.

Assessing Dosage Form Feasibility

Will an enteric-coated tablet do the trick? Is a controlled release product even feasible? Predictive PK modeling is an excellent tool to assess feasibility with relatively little time or cost outlay.

Intellectual Property Generation

Predictive PK modeling is especially effective in the generation of protective IP. In many cases, the ideal release profile for a dosage form is not immediately obvious. That said, once we determine what it is, we can help prepare a patent that covers not just one CR dosage form, but also multiple formulation approaches used to meet the target.

, PharmaDirections
, PharmaDirections

Drug Developers

We have seasoned experts in many different therapeutic moieties and indications that will strategize and build a full-spectrum team around your innovation to push it forward, into patients and toward approval.

, PharmaDirections

Program Managers

Our Program Leaders and Project Managers drive the execution of coordinated campaigns from drug discovery to preclinical research to clinical trials.

, PharmaDirections

Drug Discoverers

Our experts design and execute a variety of studies aimed at rational lead selection and optimization based on pre-established target product profiles.

, PharmaDirections

CMC Experts & Quality Managers

From sourcing starting materials to formulating your drug product, we provide expertise in chemistry, biology, formulation and manufacturing of both small and large molecules.

, PharmaDirections

Preclinical Experts

We design and oversee the in vivo and in vitro studies you need to assure regulators your molecule is safe enough to treat humans.

, PharmaDirections

Predictive Pharmacokinetic Modelers

We analyze PK data and use sophisticated computer tools to design dosage forms and optimize dosing regimens.

, PharmaDirections

Regulatory Experts & Managers

Our seasoned experts have helped advance countless new and repurposed drugs from investigational applications (e.g. INDs) through to marketing approval in the U.S. and abroad.

, PharmaDirections

Intellectual Property Inventors

Patent applications are part of regular routine. We generate your IP but we take no ownership stake in it.

, PharmaDirections

REQUEST A CONSULTATION

Contact Cathi Clark, our VP of Business Development to Get Started!

Back To Top