Affiliations 

  • 1 Department of Pharmaceutical Chemistry, School of Pharmacy, International Medical University, 126, Jalan Jalil Perkasa 19, Bukit Jalil, 57000 Kuala Lumpur, Malaysia; Centre of Excellence for Bioactive Molecules and Drug Delivery, Institute for Research, Development & Innovation, International Medical University, 126, Jalan Jalil Perkasa 19, Bukit Jalil, 57000 Kuala Lumpur, Malaysia; School of Postgraduate Studies and Research, International Medical University, 126, Jalan Jalil Perkasa 19, Bukit Jalil, 57000 Kuala Lumpur, Malaysia
  • 2 Drug Discovery Unit, Wellcome Centre for Anti-Infectives Research (WCAIR), Division of Biological Chemistry and Drug Discovery, School of Life Sciences, University of Dundee, Dundee, UK
  • 3 Department of Pharmaceutical Chemistry, School of Pharmacy, International Medical University, 126, Jalan Jalil Perkasa 19, Bukit Jalil, 57000 Kuala Lumpur, Malaysia; Centre of Excellence for Bioactive Molecules and Drug Delivery, Institute for Research, Development & Innovation, International Medical University, 126, Jalan Jalil Perkasa 19, Bukit Jalil, 57000 Kuala Lumpur, Malaysia. Electronic address: mallikarjunarao@imu.edu.my
Drug Discov Today, 2021 Nov 10.
PMID: 34774767 DOI: 10.1016/j.drudis.2021.11.005

Abstract

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.