Pharmacokinetics and Pharmacodynamics of Biologics: Analyzing the Unique Characteristics of Biologics in Terms of Their Absorption, Distribution, Metabolism, and Excretion

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Autore principale: Punam Bangar*, Sejal Bhandari, Swapnil Kale, Sneha Kanase
Natura: Recurso digital
Pubblicazione: Zenodo 2025
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author Punam Bangar*, Sejal Bhandari, Swapnil Kale, Sneha Kanase
author_facet Punam Bangar*, Sejal Bhandari, Swapnil Kale, Sneha Kanase
contents <p><span lang="EN-US">Biologics, such as monoclonal antibodies, fusion proteins or recombinant cytokines, have changed the landscape in the treatment of many diseases. On the other hand, due to their large molecule size, advanced structure, and being native like endogeneous substances, the pharmacokinetics (PK) and pharmacodynamics (PD) of these drugs are fundamentally different from those of small molecule drugs. PD of biologics are generally target driven; however, they are closely related to its PK through TMDD and immunogenicity. This review highlights that the intricate relationship of the biologic structure, its target and the patients’ immune system determines the clinical exposure, efficacy and safety of a therapeutic. Appreciation for these distinct ADME characteristics is vital for rational design, preclinical development, and clinical dosing of biologic therapeutics.</span></p>
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spellingShingle Pharmacokinetics and Pharmacodynamics of Biologics: Analyzing the Unique Characteristics of Biologics in Terms of Their Absorption, Distribution, Metabolism, and Excretion
Punam Bangar*, Sejal Bhandari, Swapnil Kale, Sneha Kanase
Pharmacokinetics of biologics, Routes of administration, Difference in bioavailability across routes, Cause of low bioavailability, assessing bioavailability, Plasma protein binding, Volume of distribution, tissue penetration and bio-distribution, Pharmacodynamics of biologics, Dose-response relationship, Factors influencing PK/PD of biologics
<p><span lang="EN-US">Biologics, such as monoclonal antibodies, fusion proteins or recombinant cytokines, have changed the landscape in the treatment of many diseases. On the other hand, due to their large molecule size, advanced structure, and being native like endogeneous substances, the pharmacokinetics (PK) and pharmacodynamics (PD) of these drugs are fundamentally different from those of small molecule drugs. PD of biologics are generally target driven; however, they are closely related to its PK through TMDD and immunogenicity. This review highlights that the intricate relationship of the biologic structure, its target and the patients’ immune system determines the clinical exposure, efficacy and safety of a therapeutic. Appreciation for these distinct ADME characteristics is vital for rational design, preclinical development, and clinical dosing of biologic therapeutics.</span></p>
title Pharmacokinetics and Pharmacodynamics of Biologics: Analyzing the Unique Characteristics of Biologics in Terms of Their Absorption, Distribution, Metabolism, and Excretion
topic Pharmacokinetics of biologics, Routes of administration, Difference in bioavailability across routes, Cause of low bioavailability, assessing bioavailability, Plasma protein binding, Volume of distribution, tissue penetration and bio-distribution, Pharmacodynamics of biologics, Dose-response relationship, Factors influencing PK/PD of biologics
url https://doi.org/10.5281/zenodo.17539300