Abstract
Abstract This chapter presents a brief historical perspective on how the roles of drug metabolism and pharmacokinetics (DMPK) and the key enablers for studying the absorption, distribution, metabolism, and excretion (ADME) processes of small molecule (SM) drugs and their underlying mechanisms have evolved over time in order to influence internal de‐risking strategy and decisions. It reviews external factors, such as changing regulatory environments and evolving large molecule (LM) discovery and development landscape. The chapter also provides an overview of a DMPK concept analogy between SMs and LMs, as well as case examples to demonstrate the applicability of SM DMPK knowledge and experiences to LM drug discovery and development. The commonly used bioanalytical methods for the determination of LMs in biological fluids are ligand‐binding assays that are immunological in nature. These assays usually have an associated degree of nonspecificity.
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