Getting Faster Regulatory Approval through PK/PD

July 14, 2023
Getting Faster Regulatory Approval through PK/PD
Getting Faster Regulatory Approval through PK/PD

Getting Faster Regulatory Approval through PK/PD

Clinical pharmacology is the study of how medications interact with the human body. Clinical pharmacology is divided into two sections: pharmacokinetics and pharmacodynamics. Pharmacokinetics and pharmacodynamics, which both play a key role in assessing a medication's safety and efficacy, measure and explain the complex biochemical interactions that occur between the body's natural processes and the chemical composition of a pharmaceutical drug.

Regulatory authorities such as the FDA are in charge of approving new pharmaceuticals and deciding whether or not a drug should be removed from the market. Regulatory bodies are also in charge of ensuring that all pharmaceuticals on the market are both effective and safe for human consumption. Pharmacokinetics and pharmacodynamics play a role in determining the safety and efficacy of any medicine.

PK and PD: The Difference

The major distinction between pharmacokinetics and pharmacodynamics is that pharmacokinetics (PK) refers to drug movement in the body, whereas pharmacodynamics (PD) refers to the body's biological reaction to medications.

In other words, PK refers to a medication's absorption, distribution, metabolism and excretion (often referred to as ADME), whereas PD refers to how biological systems in the body respond to or are influenced by a drug. Simply put, pharmacokinetics is what the body does to the medication and pharmacodynamics is what the drug does to the body.

PD depicts a drug's reaction in terms of biochemical or molecular interactions, whereas PK describes a drug's exposure by measuring its ADME characteristics and bioavailability as a function of time. When PK and PD are combined, they form an exposure/response connection.

Every drug's development and approval hinges on an understanding of the exposure-response connection (PK/PD). About 25%  of the information in a medicine package insert or label comes from PK and PD statistics. An effective pharmacokinetic study design and strategic planning of the whole drug development programme can assist and speed up the development process and guarantee that safety and efficacy objectives are met.

Why is PK/PD Important?

The importance of PK and PD studies is that they assist us to understand how medications function in the body and how the body reacts to drugs.

Drug developers utilize the information gleaned from PK and PD assessments to help plan clinical trials (i.e., what dose to use or how different drugs interact with each other in the body).

Clinicians treat distinct groups of patients using the information from PK and PD studies (as reported on the medicine label or package insert). For example, patients with and without renal impairment or elderly versus younger patients.

PK and PD: Uses

A variety of essential drug development factors linked to clinical study design may be determined using PK and PD analysis. Analyses of PK and PD can be utilized to:

  • Characterize drug exposure
  • Determine an appropriate dose for a clinical study
  • Assess changes in dose requirements
  • Estimate the rate of elimination and absorption
  • Assess relative bioavailability/bioequivalence
  • Characterize intra- and inter-subject variability
  • Understand concentration-effect relationships
  • Establish safety margins and efficacy characteristics

Learn More

Aside from the basics mentioned in the above article, understanding PK and PD for regulatory purposes requires knowledge of an even broader variety of topics, such as:

  • Preclinical and Clinical PK/PD studies
  • The dose-exposure-effects
  • Clockwise and counter-clockwise hysteresis
  • The application of MRSD and MABEL approaches
  • Microdosing
  • Biological and advanced therapies
  • Population pharmacokinetics (study design, data interpretation, etc.)
  • Temporal placement throughout the drug R&D programme and more

If you are a regulatory professional, clinical/non-clinical scientist, medical affairs officer or are in any way related to the drug development sector, it is crucial that you have a firm grasp of pharmacokinetics and pharmacodynamics.

PK/PD in Streamlining Drug Development is a two-day live virtual masterclass conducted by Keynotive to help such individuals obtain the knowledge required to achieve a successful regulatory submission. This detailed course will be conducted by Dr. Stefano Persiani (Director - Translational Sciences and Pharmacokinetics, Rottapharm Biotech, Italy).

Spots are limited, so sign up today!