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Over the past decade, there has been increased investment to the development of biotechnologically derived drug products or biologics (including peptides, proteins, and monoclonal antibodies, mAbs, aggregately referred as large molecule (LM) drugs) in pharmaceutical companies [1, 2]. These are attributable to the reported therapeutic success of this modality thus far, together with the rapid advancement and breakthroughs in the fields of recombinant DNA biotechnology and molecular biology.
However, reports on mechanistic investigation of absorption, distribution, metab- olism, and excretion (ADME) processes for LMs are sparse and our current understanding of the associated mechanisms and key determinants of pharmacokinetic (PK) properties is scant.
Conceivably, these are related to the fact that the biophar- maceutical industry is still at an early stage, relative to the traditional pharmaceutical counterpart; the first approved LM drug product was in 1980s , several decades after many small molecule (SM) drugs were on the market. In addition, unlike the discovery and development of SM drugs, where the sciences and the functional role of drug metabolism and phar- macokinetics (DMPK) in studying and understanding ADME processes have been well recognized as an indispensable and integral discipline spanning from early discovery to development and postmarketing spaces , the function of DMPK in support of LM drug development is somewhat limited to mostly in vivo PK and/or pharmacokinetics/pharmacodynamics (PK/PD) studies, typically after candidate selection and primarily in the clinical space. Despite the intrinsic difference between SM and LM drugs, it should be of particular interest to appraise the relevance and applicability of what we have learned over the past few decades from the discovery and development of SM drugs to the same process of LMs. Thus, in this chapter, a brief historical perspective is presented on how the roles of DMPK and the key enablers for studying
the ADME processes of SM drugs and their underlying mechanisms have evolved over time in order to influence internal de‐risking strategy and decisions. External factors, such as changing regulatory environments and evolving LM discovery and development landscape, are briefly reviewed.
Also presented is an overview of a DMPK concept analogy between SMs and LMs, as well as case examples to demon- strate the applicability of SM DMPK knowledge and experi- ences to LM drug discovery and development.
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