ABSTRACT
This chapter explains the biopharmaceutical aspects of biologics while discussing the small molecules administered parenterally and physiochemical properties that are important considerations for discovery and development. It focuses on the physicochemical properties of small-molecule drugs that influence their adsorption by the parenteral route. The chapter discusses the basics of exposure Pharmacokinetics (PK) and exposure–response analysis that are applicable to both biotherapeutics and small molecules. Many biotherapeutics, especially macromolecules because of their structure and physicochemical properties, possess distinct the absorption, distribution, metabolism, and excretion properties from typical synthetic small molecules. Understanding the PK–pharmacodynamics relationship is critical in order to determine the clinical dose and dosing regimen. Drugs produce different types of pharmacological effects at the target tissue. There is a possibility of an impact on pharmacology and subsequently on clinical safety or efficacy of other biologics in the same class due to the antidrug antibody formation against one therapeutic.
