PK/PD Analysis and Modeling

PK/PD Analysis and Modeling

Pharmacokinetic/pharmacodynamic (PK/PD)-modeling links dose-concentration relationships (PK) and concentration-effect relationships (PD), thereby facilitating the description and prediction of the time course of drug effects resulting from a certain dosing regimen. Pharmacokinetic/pharmacodynamic (PK/PD)-modeling is a part of the drug development process, and is a mathematical technique that predicts changes in drug efficacy over time and dose.

PK/PD-modeling is applied in the pre-clinical and drug development stages, and its analysis of data will be beneficial to drug development. In addition, the concepts of PK/PD will provide a more rational basis for patient-specific individualization treatment and thus may guide applied pharmacotherapy to a higher level of performance in clinical treatment.

Our Services

PK/PD analysis and modeling can be applied both in the pre-clinical and clinical stage. During drug development, they will provide valuable support to make important decisions. Our following services are provided for PK/PD analysis and modeling at different stages of drug development (Figure 1):

Figure 1. The steps of PK/PD-modeling.

• In preclinical phase

The preclinical phase of drug development includes a number of in vitro and animal studies to screen compounds for efficacy and safety. In preclinical phase, the PK/PD analysis and modeling service we provide has a lot of advantages, such as selecting the optimal compound, if more than one is available, predicting clinical potency estimates (EC50), providing the guidance for the dose range to be tested in early clinical trials, providing guidance for optimal sampling, assessing the margin of safety on the basis of target efficacy concentrations, predicting oral bioavailability, predicting hepatic clearance and assessing the potential for drug–drug interactions.

• In clinical phase

The usefulness of PK/PD analysis and modeling in the clinical stage can be divided into three stages:

Phase I studies provide initial human data for the tested compound and include a small number of short studies in healthy subjects or patients. They provide early data on human tolerability, PK and sometimes PD.

Phase II includes studies in carefully selected patients from the patient population of interest. They provide data across a dose range and help to assess a dose–response relationship.

Phase III studies provide the final confirmation of the efficacy and safety of the tested drug in a wide patient population of interest. They provide the ultimate safety and efficacy data for the approval of drug’s use in clinical practice.

We guarantee the confidentiality and sensitivity of our customers' data. We are committed to providing you timely and high-quality deliverables. At the same time, we guarantee cost-effective, complete and concise reports.

If you are unable to find the specific service you are looking for, please feel free to contact us.

References:
1. Rajman, I. (2008) ‘PK/PD modelling and simulations: utility in drug development.’ Drug Discovery Today, 13(7), 341-346.
2. Derendorf, Hartmut, and B. Meibohm. (1999) ‘Modeling of Pharmacokinetic/Pharmacodynamic (PK/PD) Relationships: Concepts and Perspectives.’ Pharmaceutical Research, 16(2), 176-85.
3. Karlsson, Mats O., et al. (2005) ‘Pharmacokinetic/Pharmacodynamic Modelling in Oncological Drug Development.’ Basic & Clinical Pharmacology & Toxicology, 96(3), 206-211.