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PKPD model

Class of models in pharmacology

Class of models in pharmacology

PKPD modeling (pharmacokinetic pharmacodynamic modeling) (alternatively abbreviated as PK/PD or PK-PD modeling) is a technique that combines the two classical pharmacologic disciplines of pharmacokinetics and pharmacodynamics. It integrates a pharmacokinetic and a pharmacodynamic model component into one set of mathematical expressions that allows the description of the time course of effect intensity in response to administration of a drug dose. PKPD modeling is related to the field of pharmacometrics.

Central to PKPD models is the concentration-effect or exposure-response relationship. A variety of PKPD modeling approaches exist to describe exposure-response relationships. PKPD relationships can be described by simple equations such as linear model, Emax model or sigmoid Emax model. However, if a delay is observed between the drug administration and the drug effect, a temporal dissociation needs to be taken into account and more complex models exist:

  • Direct vs Indirect link PKPD models
  • Direct vs Indirect response PKPD models
  • Time variant vs time invariant
  • Cell lifespan models
  • Complex response models PKPD modeling has its importance at each step of the drug development and it has shown its usefulness in many diseases. The Food and Drug Administration also provides guidances for Industry to recommend how exposure-response studies should be performed.

References

References

  1. (2011). "Two-stage vs mixed-effect approach to pharmacodynamic modeling of propofol in children using state entropy". Pediatric Anesthesia.
  2. (2008). "The Hill equation: A review of its capabilities in pharmacological modelling". Fundamental & Clinical Pharmacology.
  3. (1999). "Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: Concepts and perspectives". Pharmaceutical Research.
  4. (2014). "Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development: Part 3-Introduction to Pharmacodynamic Modeling Methods". CPT: Pharmacometrics & Systems Pharmacology.
  5. (October 1997). "Basic concepts of pharmacokinetic/pharmacodynamic (PK/PD) modelling". International Journal of Clinical Pharmacology and Therapeutics.
  6. Pharmaceutical Biotechnology: Fundamentals and Applications. Crommelin, Daan; Meibohm, Bernd; Sindelar, Robert. Third Edition. Informa Healthcare USA. 2008.
  7. (2003-05-01). "Diversity of Mechanism-Based Pharmacodynamic Models". Drug Metabolism and Disposition.
  8. (August 1993). "Comparison of Four Basic Models of Indirect Pharmacodynamic Responses". Journal of Pharmacokinetics and Biopharmaceutics.
  9. (May 2001). "Role of modelling and simulation in Phase I drug development". European Journal of Pharmaceutical Sciences.
  10. Rajman, Iris. (2008-04-01). "PK/PD modelling and simulations: utility in drug development". Drug Discovery Today.
  11. (2005-03-01). "Pharmacokinetic/Pharmacodynamic Modelling in Oncological Drug Development". Basic & Clinical Pharmacology & Toxicology.
  12. Food and Drug Administration. (2018-08-24). "Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications".
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