Pharmacokinetic/pharmacodynamics – PK PK modeling, an integral component of the drug development process, is a mathematical technique for predicting the effect and efficacy of drug dosing over time. The derived dataset from preclinical PK PD Studies may contain any PK data along with safety or efficacy data. Understanding the exposure-response relationship in the form of PK PD studies is key to the development and approval of every drug. Data from our preclinical PK PD services contribute to much of what is on a drug package insert. Strategic planning of the overall program for a drug and intelligent pharmacokinetic study design can speed the development process.
Assessment of data from PK PD studies variability population along with safety or efficacy data in early phases of clinical trials is an important aspect of clinical data analysis. Broadly speaking, pharmacokinetic models describe how the body reacts to a drug in terms of absorption, distribution, metabolism, and excretion. Pharmacodynamic models describe how a drug affects the body by linking the drug concentration to an efficacy (or safety) metric. A well-characterized PK PD studies are an important tool in guiding the design of future experiments and trials.
The PK PD modelling process includes the following steps:
- Import, process, and visualize time-course data
- Select a pharmacokinetic model from a library, or create mechanism-based models of PK PD studies using the interactive block-diagram editor
- Estimate model parameters using nonlinear regression or NLME methods
- Explore system dynamics, using parameter sweeps and sensitivity analysis
- Simulate dosing strategies and what-if scenarios
PK PD Studies are used to:
- Characterize drug exposure: With the exception of drugs delivered intravenously, only a fraction of a drug’s dose is absorbed and pharmacologically active. Quantifying the rate and magnitude of exposure to a drug is critical for determining how best to guide its use in the clinic.
- Predict dosage requirements: PK PD modelling can help predict dosing requirements early in the development process, making the first dose-range finding studies more informative and consequential.
- Assess changes in dosage requirements: Predicting the biological effect of small dosing changes is important early in the development process, when alterations and formulation changes are common.
- Estimate rate of elimination and rate of absorption: Knowing how quickly a drug is absorbed and eliminated can help make decisions regarding formulation design and dosing regimens.
- Assess relative bioavailability / bioequivalence: Comparing the extent of a new formulation’s absorption to an existing formulation can often help demonstrate therapeutic advantages.
- Characterize intra- and inter-subject variability: High variability can quickly derail clinical development programs. Understanding how a drug’s PK PD properties change within and between individuals can help design clinical trials in ways that reduce variability and make the results more robust.
- Understand concentration-effect relationships: The concentration-effect relationship is the cornerstone of pharmacodynamics. Identifying the variables that affect the relationship is critical for a successful development program.
- Establish safety margins and efficacy characteristics: Successful drugs have clearly defined therapeutic windows. PK PD studies can help determine dosing thresholds. Sola dosis facit venenum… “The dose makes the poison.”
We embrace the notion that simplicity and clarity lead to good decisions. We take complex pharmacokinetic principles and make them understandable and usable for common sense drug development. Many of our Pharmacokinetics Consultants have 15-30 years of industry experience. They conduct highly experienced analyses in a fully validated computing environment with the latest PK modeling software.
GVK BIO stands out among other CROs providing biology solutions in terms of our expertise and customer service. With focus on providing quality
PK PD modelling and simulation
We design, plan, analyze and report:
- FTIM, single dose PK, metabolic, PD (markers, surrogates),
- Absolute bioavailability, bioequivalence,
- Repeat-dose PK, dose-proportionality,
- Drug, food or disease interaction studies.
We perform PK and PK PD Analysis:
- Non-compartmental PK analysis
- Individual modeling
- Population PK PD modelling
As a reliable partner of the top global pharma companies and research agencies, GVK BIO brings together the market-leading expertise PK PD services. We are recognized as the world leader for providing the largest and most diverse portfolio of standard and custom PK PD studies.