TY - JOUR
T1 - The role of DMPK science in improving pharmaceutical research and development efficiency
AU - Mak, Kit-Kay
AU - Epemolu, Ola
AU - Pichika, Mallikarjuna Rao
N1 - Funding - International Medical University, Kuala Lumpur, Malaysia, for financial support [Project ID: PMHS I-2018 (02)].
Copyright © 2021 Elsevier Ltd. All rights reserved.
PY - 2022/3/2
Y1 - 2022/3/2
N2 - The successful regulatory authority approval rate of drug candidates in the drug development pipeline is crucial for determining pharmaceutical research and development (R&D) efficiency. Regulatory authorities include the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceutical and Food Safety Bureau Japan (PFSB), among others. Optimal drug metabolism and pharmacokinetics (DMPK) properties influence the progression of a drug candidate from the preclinical to the clinical phase. In this review, we provide a comprehensive assessment of essential concepts, methods, improvements, and challenges in DMPK science and its significance in drug development. This information provides insights into the association of DMPK science with pharmaceutical R&D efficiency.
AB - The successful regulatory authority approval rate of drug candidates in the drug development pipeline is crucial for determining pharmaceutical research and development (R&D) efficiency. Regulatory authorities include the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceutical and Food Safety Bureau Japan (PFSB), among others. Optimal drug metabolism and pharmacokinetics (DMPK) properties influence the progression of a drug candidate from the preclinical to the clinical phase. In this review, we provide a comprehensive assessment of essential concepts, methods, improvements, and challenges in DMPK science and its significance in drug development. This information provides insights into the association of DMPK science with pharmaceutical R&D efficiency.
KW - DMPK
KW - ADME/T
KW - Drug discovery and development
KW - Pharmaceutical R&D efficiency
KW - PBPK modelling
KW - Allometric scaling
UR - http://www.scopus.com/inward/record.url?scp=85119663740&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2021.11.005
DO - 10.1016/j.drudis.2021.11.005
M3 - Review article
C2 - 34774767
SN - 1359-6446
VL - 27
SP - 705
EP - 729
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 3
ER -