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EXPERTISE

PK & PD Analysis

Discover what the body does to your investigational drug and where it goes with Pharmacokinetic (PK) and Pharmacodynamics (PD) analysis.

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What is PK/PD Analysis?

Pharmacokinetic (PK) is defined as the movement of the drug throughout the body, i.e. what the body does to the drug. It looks at the absorption, distribution, metabolism and elimination of the drug within the human body.

PK studies enable drug developers to interpret the relationship of dose (or effect of other covariates e.g. blood pressure, heart rate etc.) to blood or plasma concentrations of drugs in various patient populations. Furthermore, PK studies help determine the need for dose adjustment based on PK differences among demographic subgroups or subgroups with impaired elimination. PK studies also provide the basis for therapeutic drug monitoring in rare patient populations, in the treatment of certain cancers (e.g. methotrexate) or when effective drugs with very narrow safe therapeutic windows must be used.

PK integrates with both Statistics and Programming or can be used as a stand-alone service, where the client already has Statistics and Programming support.

PK work with Bioanalysis labs (labs that quantify the concentrations of drugs from clinical trials) and on receipt of Bioanalytical data (Excel or SAS format) can run this through PK software (Phoenix WinNonlin) to calculate PK parameters. The PK Team can work alongside Statistics and Programming at other companies (if they have this capability) or can work alongside our own Statistics and Programming department if needed (not always needed if quick interim analyses, ad-hoc analyses).

Pharmacodynamics (PD) analysis allow drug developers to quantify the relationship between the drug dose and the pharmacologic or toxicologic effect it has on patients. The results of PD studies can often be impacted by the response of the receptor. This is often the due to the presence of drugs competing for the same receptor. 

Pharmacokinetic & Pharmacodynamic Services

One of the main reasons for drug attrition in clinical development is poor pharmacokinetics. To reduce this risk, it is essential to fully investigate the pharmacokinetics of a new drug during each stage of development.

Quanticate’s automated systems use the latest versions of Phoenix WinNonlin® and SAS® to deliver high quality PK reports, along with additional PK, PD, and PK/PD services, including:

Input into study design, including sample size estimation and optimization of PK sampling

Non-compartmental PK modelling

Fast turnaround interim PK analyses in support of first-time-in-man studies

Input into Clinical Study Reports

Compartmental PK modelling

Statistical analyses including bioequivalence, bioavailability, food-effect, drug-drug interactions, dose-proportionality and special populations

PK Handover  Document Production

PD analyses using various graphical and statistical approaches

PK/PD linear and non-linear mixed modeling techniques

Simulation to help predict systemic exposure (and PD effects) for alternative dosing regimens

Get the specialist software and expertise you need to discover what the regulatory body does to your investigational drug and where it goes with PK and PD analysis

 

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Resources to help you produce high quality PK/PD reports

WHITEPAPER

Discover the benefits of what to include in a PK Handover Document

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WHITEPAPER

Use PK analyses to prove clinical comparability between biologics and biosimilars

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WHITEPAPER

Significantly reduce the risk of failure in Phase 3 trials with PK modelling

Reduce your risks

WHITEPAPER

Learn how to ensure safe and effective dosing of an IMP in clinical trials

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