Skip to 0 minutes and 15 seconds Dear fellow students, good morning or good afternoon depending on when and where you are. So without further self-introduction, we are going to discuss part five of this mini biotechnology series. Part 5 is pharmacokinetic and pharmacodynamic correlations of biotechnology product or PK/PD correlations of biotechnology product.
Skip to 0 minutes and 49 seconds And the reading material is taken from this reference.
Skip to 0 minutes and 58 seconds Learning objectives. What do I expect you to learn from this lecture? To be able to illustrate the PK differences between small molecule drugs and large therapeutic proteins. To describe the differences in absorption between drugs and biologics and the approaches to enhancing the absorption of biologics.
Skip to 1 minute and 30 seconds To explain the effect of macromolecule binding on the distribution and elimination of protein and peptide drugs. To describe the renal excretion of biologics. And to describe the hepatic metabolism of biologics.
Skip to 1 minute and 53 seconds Also to discuss the effect of immunogenic response on pharmacokinetics of therapeutic proteins. And to summarize the structural modifications to change the pharmacokinetics of peptide. To illustrate the PK/PD models and the correlations for therapeutic proteins.
Skip to 2 minutes and 19 seconds So what is pharmacokinetics and pharmacodynamics? First, pharmacodynamics. What does the drug do to the body? That’s pharmacodynamics. And that is also the drug’s action on the body. In this relationship, we look at the effect versus concentration or the effect versus dose.
Skip to 2 minutes and 48 seconds On the other hand, pharmacokinetics is what the body does to the drug. And that is the body’s reaction to the drug. In this regard, we look at the concentration-time relationship of the drug or the biologics. So when we put two together, PK/PD correlation, we integrate the pharmacokinetics and pharmacodynamics into effect-time relationship. And this relationship is what exactly we need for dosing arrangement adjustment. So to quickly summarize, the concentration-time response or the relationship rather is pharmacokinetics, the effect-concentration relationship is pharmacodynamics. And when the two are integrated together, it becomes the effect versus time relationship. There are important applications of PK/PD correlation. First, what drug to use? That is to determine the rational use of drugs. And how to use it?
Skip to 4 minutes and 10 seconds That is the effective dosing regimens. Also individualized medicine. Discovery of new drugs with greater efficiency is one important application of PK/PD correlation.
Introduction to PK/PD correlation
Welcome to week 5. This week, we are going to learn PK/PD (pharmacokinetic/pharmacodynamic) Correlations of Biotechnology Products. Pharmacodynamics (PD) is the drug’s action on the body, and Pharmacokinetics (PK) is the reaction of the body system to the drug. When the two elements are combined, the response-time course relationship is established, which enable optimization of dosing regimen for an individual patient or a certain patient population. Expedited drug discovery also becomes possible by being able to predict the PK/PD characteristics of the drug candidate.
Starting with the definition of PK and PD, the latter is defined as drug’s action on the body, and the former is the reaction of the body system to the drug Five commonly used PK/PD correlation models and the accompanied mechanisms are reviewed, The applications of PK/PD modeling are elaborated as follows: Firstly, to elucidate biochemical process and mechanism of biologics action, thereby to guide decision and selection of drug candidates for streamlining the development. Secondly, to assist with the optimization of dosing regimen, and to customize medication for the individual patient or specific population. Please note here DRUG and BIOLOGICS are used interchangeably.