What is clinical pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD)?
Clinical Pharmacology (ClinPharm) is the study and use of drugs in humans – such as how drugs affect the body (PK) and how the body affects drugs (PD). Pharmacokinetics describes each drug’s:
- absorption – how drugs get in the body (e.g. absorption into the blood after oral dosing)
- distribution – how drugs get around the body (e.g. distribution to different tissues in the body)
- metabolism – how drugs get broken down by the body
- excretion – how drugs get out of the body (e.g. excretion in urine)
What is a PK/PD analysis?
Clinical pharmacology investigations involve enrolling subjects (healthy volunteers or patients with disease) into a clinical study and having them take a test compound or study drug. Blood or other human fluids (e.g., urine, saliva, spinal fluid, etc.) are collected from the study subjects at specific timepoints after dosing. For example, a subject might take study drug at time zero and have blood collected at 1, 2, 3, 4, 8, 12, and 24 hours after dosing for PK analysis. These samples are sent to a bioanalytical laboratory to measure the concentration of drug in each sample.
This concentration data is then inputted into sophisticated PK software programs that look at the concentration of drug over the time intervals that samples were collected. This PK analysis determines the pharmacokinetic fingerprint (i.e., PK characteristics or PK parameters) for each drug. These parameters include the:
- maximum concentration (Cmax) of a drug after dosing
- time it takes to get to this maximum concentration (Tmax)
- total exposure to the drug (AUC – area under the curve)
- half-life of the drug in blood
- rate of clearance of the drug from the blood stream
- volume of distribution of the drug
- and many other parameters
These PK parameters give drug developers an understanding of the drug and insight into how to design next steps in their program or how to advise physicians using the drug in clinical practice after approval by the FDA. For example, pharmacokinetics tells us how often you should take drugs (once daily, twice daily, once weekly, etc.) by determining the half-life. Drugs are typically dosed on the half-life, for example, a drug with a 20-24 hour half-life will typically be taken once daily.
Do I need to do a PK/PD analysis?
Every drug on the pharmacy shelf has had some manner of clinical pharmacology and pharmacokinetic evaluation conducted in order for it to be used by physicians in general practice. However, not all clinical pharmacology and pharmacokinetic evaluations are created equal. There are multiple and complex considerations that must be considered when designing, executing, analyzing, and reporting clinical studies that involve pharmacokinetic evaluations.
Why Nuventra for my PK/PD analysis?
At Nuventra, we are experts at clinical pharmacology investigations and conducting a Phase 1 study with an emphasis on PK analysis. We do pharmacokinetic analysis using sophisticated software to determine the PK fingerprint (i.e., PK characteristics or PK parameters) for a given drug. We conduct both noncompartmental and compartmental traditional PK analysis (rich sampling – e.g., sampling blood multiple times from an individual subject) using validated PK/PD software. We also perform population PK analyses (sparse sampling – e.g., sampling blood only a few times from multiple individuals in a study population) using the software package NONMEM.
Nuventra does not have a clinic to enroll subjects into a study nor do we have a bioanalytical laboratory to measure the concentration of drug in each PK sample. Nuventra takes a common sense approach based on scientific principles to provide excellence in clinical pharmacology and pharmacokinetics and successfully navigate companies through the drug development process leading to marketing approval (i.e. approval by regulatory agencies like the FDA and EMA). Nuventra utilizes regulatory guidance documents, therapeutic area understanding, drug class characteristics, knowledge of current FDA requirements, past experience with similar development programs, and extensive knowledge of clinical pharmacology options to enable successful drug development programs.
We also function as an extension of each of our clients, offering clinical pharmacology consulting services including detailed program strategy, IND planning, regulatory affairs, medical and regulatory writing, PK analysis, and Phase 1 clinical operations management.
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