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Pharmacokinetics and Pharmacodynamics (PK/PD) Studies

2017-07-20
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Pharmacokinetic / pharmacodynamics (PK/PD) modeling, an integral component of the drug development process, is a mathematical technique for predicting the effect and efficacy of drug dosing over time. 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 model is an important tool in guiding the design of future experiments and trials.

PK PD Studies

PK/PD Modeling Services

    • Development of PK/PD strategy as part of the drug development plan

    • Design of standalone Pharmacokinetic(PK) studies and sub-studies

    • Sample size and power calculations

    • Generation of randomization codes

    • Preparation of analysis plans

    • Compartmental and non-compartmental pharmacokinetic analysis

    •  Pharmacodynamic analysis

    • Assessment of PK/PD relationship

    • Assessment of Bioequivalence/Bioavailability

    • Drug interaction evaluations

    • Reporting

    • PK = Pharmacokinetics

    – relationship between the dose administered and the changes in the drug concentration in the body with time. (Measured by drug concentration in blood, plasma, tissue)

    ADME

    • » Absorption

    • » Distribution

    • » Metabolism

    • » Elimination

    • PD = Pharmacodynamics

    – relationship between drug concentration and its pharmacologic effect (Effects of a drug on the body / disease)

    PK is a determinant of PD

    Pharmacokinetics is the study of what the body does to the drug.Pharmacodynamics is the study of what the drug does to the body.

    • Pharmacodynamic Parameters

    • Dose-Response Relationships

    • Therapeutic Index

    • Dose–Response Relationship

      • » The numbers of receptors

      • » The willingness of a drug to associate with a receptor = receptor affinity

      • » The presence of other compounds competing for the binding site on the receptor = agonist /antagonist

      • » The concentration of the free drug in the vicinity of the receptor = pharmacokinetics

    Therapeutic Index

    The therapeutic index (also known as therapeutic ratio), is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes death (in animal studies) or toxicity (in human studies).

    PK-PD Changes in Critical Illness

    • »  Circulatory Failure

    • » Hepatic Failure

    • » Renal Failure

    • » Systemic Inflammatory Response Syndrome

    • » Changes in Receptors in Acute Illness

    • » Protein Binding

    Related Articles:

    Preclinical Pharmacokinetic Study Service

    Drug Metabolism and Pharmacokinetics (DMPK) Studies

    Medicilon’s Preclinical Pharmacokinetic Study Services

    Medicilon’s Drug ADME/PK Assays Services

    Pharmacokinetic Assay Service

    Pharmacokinetic test / toxicokinetic test

    Pharmacokinetic Research Services

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