Clinical pharmacology to support monoclonal antibody drug development

Sharon Lu; Sharon Lu

doi:10.3934/medsci.2022014

AIMS Medical Science

2022, Volume 9, Issue 2: 322-341. doi: 10.3934/medsci.2022014

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Review

Clinical pharmacology to support monoclonal antibody drug development

Sharon Lu ^,

Scholar Rock, 301 Binney Street 3^rd floor, Cambridge, Massachusetts 02142, affiliation at the time of the study, USA

Received: 22 December 2021 Revised: 29 March 2022 Accepted: 19 April 2022 Published: 10 May 2022

Citation: Sharon Lu. Clinical pharmacology to support monoclonal antibody drug development[J]. AIMS Medical Science, 2022, 9(2): 322-341. doi: 10.3934/medsci.2022014

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Abbreviations

QSP

Quantitative systems pharmacology

BLA

Biologics license application

Pharmacokinetics

Pharmacodynamics

DDI

Drug-drug interaction

FIH

First in human

NOAEL

No observed adverse effect level

MABEL

Minimum anticipated biological effect level

HED

Human equivalent dose

STD10

Dose severely toxic to 10% rodent

MTD

Maximum tolerated dose

Pharmacology activity

Receptor occupancy

HNSTD

Highest non-severely toxic dose

TMDD

Target mediated drug disposition

MID3

Model-informed drug discovery and development

iMID3

Integrated model-informed drug discovery and development

TQT study

Thorough QT/QTc study

Acknowledgments

Author would like to thank George Nomikos, MD PhD, Amy Place, PhD, Hongcheng Liu, PhD, Deborah Meshulam, PhD, Jose Rossello, MD, and Nathalie Kertesz, PhD at Scholar Rock for scientific input and technical review.

Conflict of interest

The author declares no conflict of interest.

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