PMID- 33619657
OWN - NLM
STAT- MEDLINE
DCOM- 20211108
LR  - 20211108
IS  - 1550-7416 (Electronic)
IS  - 1550-7416 (Linking)
VI  - 23
IP  - 2
DP  - 2021 Feb 22
TI  - Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption 
      Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug 
      Administration for New Drugs.
PG  - 31
LID - 10.1208/s12248-021-00564-2 [doi]
AB  - Physiologically based pharmacokinetic (PBPK) absorption modeling and simulation 
      is increasingly used as a tool in drug product development, not only in support 
      of clinical pharmacology applications (e.g., drug-drug interaction, dose 
      selection) but also from quality perspective, enhancing drug product 
      understanding. This report provides a summary of the status and the application 
      of PBPK absorption modeling and simulation in new drug application (NDA) 
      submissions to the U.S. Food and Drug Administration to support drug product 
      quality (e.g., clinically relevant dissolution specifications, active 
      pharmaceutical ingredient (API) particle size distribution specifications). 
      During the 10 years from 2008 to 2018, a total of 24 NDA submissions included the 
      use of PBPK absorption modeling and simulations for biopharmaceutics-related 
      assessment. In these submissions, PBPK absorption modeling and simulation served 
      as an impactful tool in establishing the relationship of critical quality 
      attributes (CQAs) including formulation variables, specifically in vitro 
      dissolution, to the in vivo performance. This article also summarizes common 
      practices in PBPK approaches and proposes future directions for the use of PBPK 
      absorption modeling and simulation in drug product quality assessment.Graphical 
      abstract.
FAU - Wu, Fang
AU  - Wu F
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, 
      USA. Fang.Wu@fda.hhs.gov.
AD  - Division of Quantitative Methods and Modeling, Office of Research and Standard, 
      Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, 
      USA. Fang.Wu@fda.hhs.gov.
FAU - Shah, Heta
AU  - Shah H
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, Silver Spring, Maryland, 20993, USA.
FAU - Li, Min
AU  - Li M
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, 
      USA.
FAU - Duan, Peng
AU  - Duan P
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, Silver Spring, Maryland, 20993, USA.
FAU - Zhao, Ping
AU  - Zhao P
AD  - Office of Clinical Pharmacology, Office of Translational Sciences, Center for 
      Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, 
      Maryland, 20993, USA.
AD  - Bill & Melinda Gates Foundation, Seattle, Washington, 98109, USA.
FAU - Suarez, Sandra
AU  - Suarez S
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, Silver Spring, Maryland, 20993, USA.
FAU - Raines, Kimberly
AU  - Raines K
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, 
      USA.
FAU - Zhao, Yang
AU  - Zhao Y
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, 
      USA.
AD  - Office of Clinical Pharmacology, Office of Translational Sciences, Center for 
      Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, 
      Maryland, 20993, USA.
FAU - Wang, Meng
AU  - Wang M
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, 
      USA.
AD  - Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, Silver Spring, Maryland, 20993, USA.
FAU - Lin, Ho-Pi
AU  - Lin HP
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, 
      USA.
FAU - Duan, John
AU  - Duan J
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, Silver Spring, Maryland, 20993, USA.
FAU - Yu, Lawrence
AU  - Yu L
AD  - Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug 
      Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, 
      Maryland, 20993, USA.
FAU - Seo, Paul
AU  - Seo P
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, 
      USA. Paul.Seo@fda.hhs.gov.
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20210222
PL  - United States
TA  - AAPS J
JT  - The AAPS journal
JID - 101223209
SB  - IM
MH  - Chemistry, Pharmaceutical/standards
MH  - Computer Simulation/standards
MH  - *Drug Approval
MH  - Drug Development/*methods/standards
MH  - Drug Liberation/physiology
MH  - Gastrointestinal Absorption/*physiology
MH  - Humans
MH  - Metabolic Clearance Rate/physiology
MH  - *Models, Biological
MH  - Tissue Distribution/physiology
MH  - United States
MH  - United States Food and Drug Administration/*standards
OTO - NOTNLM
OT  - biopharmaceutics
OT  - clinically relevant drug product specifications (CRDPS)
OT  - dissolution
OT  - physiologically based pharmacokinetics (PBPK)
OT  - quality risk assessment
EDAT- 2021/02/24 06:00
MHDA- 2021/11/09 06:00
CRDT- 2021/02/23 06:17
PHST- 2020/10/16 00:00 [received]
PHST- 2021/02/01 00:00 [accepted]
PHST- 2021/02/23 06:17 [entrez]
PHST- 2021/02/24 06:00 [pubmed]
PHST- 2021/11/09 06:00 [medline]
AID - 10.1208/s12248-021-00564-2 [pii]
AID - 10.1208/s12248-021-00564-2 [doi]
PST - epublish
SO  - AAPS J. 2021 Feb 22;23(2):31. doi: 10.1208/s12248-021-00564-2.