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Review
. 2012 Sep;14(3):410-9.
doi: 10.1208/s12248-012-9353-6. Epub 2012 Apr 7.

ADME of Biologics-What Have We Learned From Small Molecules?

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Free PMC article
Review

ADME of Biologics-What Have We Learned From Small Molecules?

Thomayant Prueksaritanont et al. AAPS J. .
Free PMC article

Abstract

Thorough characterization and in-depth understanding of absorption, distribution, metabolism, and elimination (ADME) properties of a drug candidate have been well recognized as an important element in small molecule (SM) drug discovery and development. This has been the area of focus for drug metabolism and pharmacokinetics (DMPK) scientists, whose role has been evolving over the past few decades from primarily being involved in the development space after a preclinical candidate was selected to extending their involvement into the discovery stage prior to candidate selection. This paradigm shift has ensured the entry into development of the best candidates with optimal ADME properties, and thus has greatly impacted SM drug development through significant reduction of the failure rate for pharmacokinetics related reasons. In contrast, the sciences of ADME and DMPK have not been fully integrated into the discovery and development processes for large molecule (LM) drugs. In this mini-review, we reflect on the journey of DMPK support of SM drug discovery and development and highlight the key enablers that have allowed DMPK scientists to make such impacts, with the aim to provide a perspective on relevant lessons learned from SM drugs that are applicable to DMPK support strategies for LMs.

Figures

Fig. 1
Fig. 1
Structure of MK-4305
Fig. 2
Fig. 2
An illustration of pharmacokinetics and pharmacodynamics and DMPK concept analogy
Fig. 3
Fig. 3
ADME and pharmacokinetic concept analogy between SMs and LMs
Fig. 4
Fig. 4
Isomerization of aspartate in the solution

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