What Is Pharmacodynamics?

What is pharmacodynamics? Pharmacodynamics is the study of a drug’s molecular, biochemical, and physiological effects.

What Is Pharmacodynamics?

Pharmacodynamics (PD) is the study of drugs’ molecular, biochemical, and physiologic effects. In other words, it is how a certain drug concentration interacts with the body to produce biological effects.

What is Pharmacodynamics

Drugs work in our bodies in several ways. They interfere with microorganisms or germs that attack your body cells and alter how cells work in your body.

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Examples of Pharmacodynamics

Every drug wields its biological effects by interacting with receptors located on organs and tissues around the body. Some examples of these interactions in the body include the following:1 
  • Drugs binding to an active part of an enzyme 
  • Drugs that interact with cell surface signaling proteins
  • Drugs that act by binding molecules

There are two kinds of reactions that take place after consuming a drug: what the drug does to the body and what the body does to the drug. These two phenomena are known as pharmacodynamics and pharmacokinetics, respectively.

Difference Between Pharmacokinetics and Pharmacodynamics

Pharmacokinetics (PK) and pharmacodynamics are two vital aspects of pharmacology. As mentioned above, clinical pharmacodynamics studies a drug’s biochemical and physiological effects on the body. Pharmacokinetics is the study of drug absorption, distribution, and metabolism. So, pharmacodynamics is what the drug does to the body, and pharmacokinetics is what the body does to the drug.
Let’s take a detailed look at the phenomenon of pharmacokinetics:
  • Absorption: The process by which a drug is absorbed into the body from the stomach and intestine. 
  • Distribution: Distribution refers to how the drug is distributed through body fluids and tissues. 
  • Metabolism: The process by which the liver and other sense organs metabolize a drug.
  • Excretion: The process by which a drug is removed from the body through the urine, skin, and other organs. 

Main Drug Actions

The following includes the main drug actions:
  • Simulation: Selective enhancement of particular cells’ activity
  • Depression: Selective inhibition of particular cells’ activity
  • Block/Antagonize: The drug binds the receptor but does not activate it
  • Stabilize: The drug does not appear to act as a stimulant or a depressant
  • Exchange/Replace: Exchange or replace substances or gather them to form a reserve
  • Direct Chemical Reactions: Can be either beneficial (therapy) or have adverse effects

Why Pharmacodynamics Analysis Are Important

Pharmacodynamics analysis is important because it helps us understand how drugs react in the body and how the body reacts to drugs.

Why Is Applying Pharmacodynamics Models in Preclinical Trials Important?

Manufacturers apply the knowledge gained from clinical pharmacodynamics analysis to create better clinical trials. These clinical studies include what dose to use or how various drugs interact with one another.
Clinicians leverage the information from pharmacodynamics analyses to treat different patients, such as those with and without renal (kidney) impairment, older adults, and children.2 

How to Use Pharmacodynamics Analysis

Pharmacodynamics analysis can determine numerous vital drug development parameters connected to clinical study design. Pharmacodynamics can be used to:

Characterize Drug Exposure

Aside from intravenous (IV) drugs, only a small portion of the drug dose is assimilated. Therefore, measuring the rate and extent of drug exposure is essential for determining how to guide its use in the clinic.

Determine an Appropriate Dose for a Clinical Study

Pharmacodynamics modeling in its early development process can help predict dosing requirements.

Access Changes in Dose Requirements

Changes in dose requirements must be accessed and predicted early in the developmental process to provide insights into creating better clinical trials.

Estimate the Rate of Elimination and Absorption

Understanding how rapidly a drug is absorbed and eliminated can aid in formulation design and dosing regimen selection.

Access Relative Bioavailability/Bioequivalence

Evaluating the extent of absorption of a new formulation compared to an existing formulation can help show therapeutic benefits.

Characterize Intra- and Inter-subject Variability

Knowing how a drug’s pharmacodynamics alter within and between individuals can help develop clinical trials to eliminate variability and increase credibility.

Understand the Concentration-Effect Relationship

Pharmacodynamics is built around the concentration-effect relationship. Therefore, a successful development program must identify the variables that influence the relationship.

Establish Safety Margins and Efficacy Characteristics

Effective drugs have different therapeutic windows. Thus, dosing limits can be ascertained using pharmacodynamics modeling.

Pharmacodynamics Services

There are various pharmacodynamics services that can be taken on:

PD Analysis and Reporting

This includes noncompartmental analysis (NCA) and PD modeling and simulation. NCAs are vital for evaluating exposure to a drug.3 

On the other hand, PD modeling techniques are essential in answering crucial questions like how much of the dose gets into the brain?

Designing and Interpreting Preclinical ADME and Clinical Studies

These include first-in-human studies, single ascending dose studies, food effect studies, drug-drug interaction studies, renal impairment studies, etc.

Dosing Simulations

Following the development of a model, different dosing regimens can be simulated to access exposure.

Risk Analysis

Predictive risk analysis, which integrates PD models with preclinical data, can make drug development more efficient by excluding candidates with a high risk of failure in clinical trials.

Creating Integrated Study Reports or Stand-Alone Reports

The study report should communicate the necessary information to health authorities, which necessitates delicate messaging and meticulous attention to detail.

Data Management and CDISC Dataset Generation

This is used to maximize the dataset’s utility after it has been locked; data collection and interrogation should be considered at the start of a study. Furthermore, clinical studies must be submitted to health authorities in the Clinical Data Interchange Standard Consortium (CDISC) format.
Creating Integrated Study Reports for Pharmacodynamics Services

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Resources

  1. https://www.ncbi.nlm.nih.gov/books/NBK507791/
  2. https://www.pharmacologyeducation.org/pharmacology/pharmacodynamics
  3. https://cran.r-project.org/web/packages/ubiquity/vignettes/NCA.html
  4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4014033/