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Pharmacokinetics and Pharmacodynamics (PK/PD) Studies

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Pharmacokinetics and Pharmacodynamics (PK/PD) Studies

By medicilon | Featured Stories | 20 July, 2017 |

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.

Pharmacokinetics and Pharmacodynamics (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 test / toxicokinetic test

Pharmacokinetic Research Services

ADME, Pharmacokinetics, pk study
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  • Home
  • About
    • Medicilon Overview
    • Executive Team
    • CEO Message
    • Corporate Culture
    • Company History
    • Honor
  • Services
    • Integrated Projects
      • Antibody-Drug-Antibody (ADC)
      • Preclinical Research Services
      • IND Filing
      • Bio Drug Development
      • Chemical Drug Development
      • Chemical Compound Druggability Assessment
      • Molecular Imaging & Radiochemistry
      • OINDP Development
      • Preclinical Ophthalmic Research Platform
    • Pharmacology Services
      • Cancer Xenograft Models
      • Orthotopic Models
      • Syngeneic Mouse Models
      • Transgenic Mouse Model
      • Humanized Mouse Model (hPBMCEngrafted)
      • PDX Model
      • Digestive System Models
      • Neurological Disorders Models
      • Metabolic Disease Models
      • Inflammation & Immunological Disease Models
      • Other Disease Models
    • Chemistry Services
      • Medicinal Chemistry Services
      • Synthetic Chemistry
      • Process Development Services
      • Analytical Chemistry
    • Drug Formulation
      • Pre Formulation Development
      • Analytical Development
      • Formulation Development Services
      • Generics Consistency Evaluation
      • Research on Quality Control
      • Clinical Trial Material
      • OINDP Development
    • Biology Services
      • Discovery Biology Services
      • Recombinant Protein Services
      • Computational Biology & Molecular Modeling
      • Crystallization & Structural Determination
      • Kinase Services
      • SeMet Media Sales
    • Bioanalytical Services
      • Large Molecule Bioanalysis
      • Small Molecule Bioanalysis
    • Pharmacokinetic Services
      • In Vivo Assays
      • In Vitro Assays
    • Drug Safety Evaluation
      • Inhalation Toxicity Assessment
  • Customer
    • Customer Reviews
    • New Models of Collaboration
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    • Medicilon Events
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