Key Physicochemical Characteristics Influencing ADME Properties of Therapeutic Proteins

Xing Jing; Yan Hou; William Hallett; Chandrahas G Sahajwalla; Ping Ji

doi:10.1007/978-981-13-7709-9_6

Key Physicochemical Characteristics Influencing ADME Properties of Therapeutic Proteins

Adv Exp Med Biol. 2019:1148:115-129. doi: 10.1007/978-981-13-7709-9_6.

Authors

Xing Jing¹, Yan Hou², William Hallett², Chandrahas G Sahajwalla², Ping Ji²

Affiliations

¹ U.S. Food and Drug Administration, Office of Clinical Pharmacology, DV II, Silver Spring, MD, USA. xing.jing@fda.hhs.gov.
² U.S. Food and Drug Administration, Office of Clinical Pharmacology, DV II, Silver Spring, MD, USA.

PMID: 31482497
DOI: 10.1007/978-981-13-7709-9_6

Abstract

Therapeutic proteins are a rapidly growing class of drugs in clinical settings. The pharmacokinetics (PK) of therapeutic proteins relies on their absorption, distribution, metabolism, and excretion (ADME) properties. Moreover, the ADME properties of therapeutic proteins are impacted by their physicochemical characteristics. Comprehensive evaluation of these characteristics and their impact on ADME properties are critical to successful drug development. This chapter summarizes all relevant physicochemical characteristics and their effect on ADME properties of therapeutic proteins.

Keywords: ADME; Pharmacokinetics (PK); Physicochemical characteristics; Protein therapeutics.

Publication types

Review

MeSH terms

Chemical Phenomena
Proteins / chemistry
Proteins / pharmacokinetics*
Proteins / pharmacology*
Structure-Activity Relationship

Substances

Proteins