Modernizing Preclinical Drug Development: The Role of New Approach Methodologies

Krina Mehta; Christian Maass; Lourdes Cucurull-Sanchez; Cesar Pichardo-Almarza; Kalyanasundaram Subramanian; Ioannis P. Androulakis; Jogarao Gobburu; Stephan Schaller; Catherine M. Sherwin

doi:10.1021/acsptsci.5c00162

Modernizing Preclinical Drug Development: The Role of New Approach Methodologies

Krina Mehta, Christian Maass, Lourdes Cucurull-Sanchez, Cesar Pichardo-Almarza, Kalyanasundaram Subramanian, Ioannis P. Androulakis, Jogarao Gobburu, Stephan Schaller, Catherine M. Sherwin

Research output: Contribution to journal › Review article › peer-review

Original language	English
Pages (from-to)	1513-1525
Number of pages	13
Journal	ACS Pharmacology and Translational Science
Volume	8
Issue number	6
DOIs	https://doi.org/10.1021/acsptsci.5c00162
State	Published - Jun 13 2025
Externally published	Yes

ASJC Scopus Subject Areas

Pharmacology
Pharmacology (medical)

Keywords

microphysiological system
new approach methodologies (NAM)
organ-on-chip
physiologically based pharmacokinetic (PBPK)
preclinical drug development
quantitative systems pharmacology (QSP)

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10.1021/acsptsci.5c00162

Cite this

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title = "Modernizing Preclinical Drug Development: The Role of New Approach Methodologies",

keywords = "microphysiological system, new approach methodologies (NAM), organ-on-chip, physiologically based pharmacokinetic (PBPK), preclinical drug development, quantitative systems pharmacology (QSP)",

author = "Krina Mehta and Christian Maass and Lourdes Cucurull-Sanchez and Cesar Pichardo-Almarza and Kalyanasundaram Subramanian and Androulakis, {Ioannis P.} and Jogarao Gobburu and Stephan Schaller and Sherwin, {Catherine M.}",

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T1 - Modernizing Preclinical Drug Development

T2 - The Role of New Approach Methodologies

AU - Mehta, Krina

AU - Maass, Christian

AU - Cucurull-Sanchez, Lourdes

AU - Pichardo-Almarza, Cesar

AU - Subramanian, Kalyanasundaram

AU - Androulakis, Ioannis P.

AU - Gobburu, Jogarao

AU - Schaller, Stephan

AU - Sherwin, Catherine M.

PY - 2025/6/13

Y1 - 2025/6/13

KW - microphysiological system

KW - new approach methodologies (NAM)

KW - organ-on-chip

KW - physiologically based pharmacokinetic (PBPK)

KW - preclinical drug development

KW - quantitative systems pharmacology (QSP)

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U2 - 10.1021/acsptsci.5c00162

DO - 10.1021/acsptsci.5c00162

M3 - Review article

AN - SCOPUS:105006806360

SN - 2575-9108

VL - 8

SP - 1513

EP - 1525

JO - ACS Pharmacology and Translational Science

JF - ACS Pharmacology and Translational Science

IS - 6

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Modernizing Preclinical Drug Development: The Role of New Approach Methodologies

ASJC Scopus Subject Areas

Keywords

Access to Document

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