PK and PD analyses are important because they help us understand how drugs behave in the body and how the body reacts to drugs, respectively. The Importance of Pharmacokinetic and Pharmacodynamic Analyses Strategic planning of the overall drug development program and an intelligent pharmacokinetic study design can accelerate the development process to help ensure safety and efficacy endpoints are achievable. PK and PD data contribute to about 25% of what is in a drug package insert or drug label.
Understanding the exposure-response relationship (PK/PD) is key to the development and approval of every drug. PK/PD together can be thought of as an exposure/response relationship. While PK describes a drug’s exposure by characterizing its ADME properties and bioavailability as a function of time, PD describes a drug’s response in terms of biochemical or molecular interactions. Put in the simplest terms, pharmacokinetics is what the body does to the drug and pharmacodynamics is what the drug does to the body. In other words, PK describes a drug’s absorption, distribution, metabolism, and excretion (also known as ADME) and PD describes how biological processes in the body respond to or are impacted by a drug. The main difference between pharmacokinetics and pharmacodynamics is that pharmacokinetics (PK) is defined as the movement of drugs through the body, whereas pharmacodynamics (PD) is defined as the body’s biological response to drugs. Understanding the safety and effectiveness of any drug depends, in part, on pharmacokinetics and pharmacodynamics. Regulatory agencies are also responsible for ensuring that all available drugs are effective and safe for human use. Regulatory agencies, such as the FDA, are responsible for approving new drugs or deciding whether or not a drug should be taken off the market. The complex, biochemical interactions that occur between the body’s natural processes and the chemical composition of a pharmaceutical drug are measured and described by pharmacokinetics and pharmacodynamics which both play a pivotal role in determining a drug’s safety and efficacy. Pharmacokinetics and pharmacodynamics are two broad divisions within clinical pharmacology. Clinical pharmacology is the study of the interactions between drugs and the human body.
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