Jane P F Bai

Jane P F Bai

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Jane P F Bai

Jane P F Bai

Publications by authors named "Jane P F Bai"

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29Publications

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A Computational Platform and Guide for Acceleration of Novel Medicines and Personalized Medicine.

Methods Mol Biol 2019 ;1939:181-198

Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://link.springer.com/10.1007/978-1-4939-9089-4_10
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http://dx.doi.org/10.1007/978-1-4939-9089-4_10DOI Listing
July 2019

American Society for Clinical Pharmacology and Therapeutics 2019 Annual Meeting Pre-Conferences.

CPT Pharmacometrics Syst Pharmacol 2019 Jun 4;8(6):333-335. Epub 2019 Jun 4.

Bill & Melinda Gates Foundation, Seattle, Washington, USA.

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http://dx.doi.org/10.1002/psp4.12424DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6617844PMC
June 2019

Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices.

AAPS J 2019 Jun 3;21(4):72. Epub 2019 Jun 3.

Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA.

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http://dx.doi.org/10.1208/s12248-019-0339-5DOI Listing
June 2019

Drug Repurposing for Ebola Virus Disease: Principles of Consideration and the Animal Rule.

J Pharm Sci 2019 Feb 19;108(2):798-806. Epub 2018 Sep 19.

Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

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https://linkinghub.elsevier.com/retrieve/pii/S00223549183053
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http://dx.doi.org/10.1016/j.xphs.2018.09.010DOI Listing
February 2019

Translational systems pharmacology-based predictive assessment of drug-induced cardiomyopathy.

CPT Pharmacometrics Syst Pharmacol 2018 03 17;7(3):166-174. Epub 2018 Jan 17.

Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1002/psp4.12272DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5869547PMC
March 2018

Advances in omics for informed pharmaceutical research and development in the era of systems medicine.

Expert Opin Drug Discov 2018 01 27;13(1):1-4. Epub 2017 Oct 27.

d College of Pharmacy , University of Illinois at Chicago , Chicago , Illinois , USA.

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http://dx.doi.org/10.1080/17460441.2018.1394839DOI Listing
January 2018

A Biologically-Based Computational Approach to Drug Repurposing for Anthrax Infection.

Toxins (Basel) 2017 03 10;9(3). Epub 2017 Mar 10.

School of Mechanical Engineering, National Technical University of Athens, Zografou 15780, Greece.

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http://dx.doi.org/10.3390/toxins9030099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5371854PMC
March 2017

Trastuzumab-Related Cardiotoxic Effects in Taiwanese Women: A Nationwide Cohort Study.

JAMA Oncol 2016 Oct;2(10):1317-1325

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1001/jamaoncol.2016.1269DOI Listing
October 2016

Pharmacodynamics and Systems Pharmacology Approaches to Repurposing Drugs in the Wake of Global Health Burden.

Authors:
Jane P F Bai

J Pharm Sci 2016 10 12;105(10):3007-3012. Epub 2016 Aug 12.

Office of Clinical Pharmacology, Center for Drug Research and Evaluation, U.S. Food and Drug Administration, Silver Spring, Maryland 20993. Electronic address:

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http://dx.doi.org/10.1016/j.xphs.2016.07.004DOI Listing
October 2016

Computational Approaches to Accelerating Novel Medicine and Better Patient Care from Bedside to Benchtop.

Adv Protein Chem Struct Biol 2016 29;102:147-79. Epub 2015 Oct 29.

Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. Electronic address:

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http://dx.doi.org/10.1016/bs.apcsb.2015.09.005DOI Listing
August 2016

Computed Biological Relations among Five Select Treatment-Related Organ/Tissue Toxicities.

Chem Res Toxicol 2016 05 21;29(5):914-23. Epub 2016 Apr 21.

Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration , Silver Spring, Maryland 20993, United States.

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http://dx.doi.org/10.1021/acs.chemrestox.6b00060DOI Listing
May 2016

Literature Review of Gastrointestinal Physiology in the Elderly, in Pediatric Patients, and in Patients with Gastrointestinal Diseases.

J Pharm Sci 2016 Feb 12;105(2):476-483. Epub 2016 Jan 12.

Division of Gastroenterology and Inborn Error Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.

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https://linkinghub.elsevier.com/retrieve/pii/S00223549150016
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http://dx.doi.org/10.1002/jps.24696DOI Listing
February 2016

Identification of drug-specific pathways based on gene expression data: application to drug induced lung injury.

Integr Biol (Camb) 2015 Aug;7(8):904-20

Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://xlink.rsc.org/?DOI=C4IB00294F
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http://dx.doi.org/10.1039/c4ib00294fDOI Listing
August 2015

Systems pharmacological analysis of drugs inducing stevens-johnson syndrome and toxic epidermal necrolysis.

Chem Res Toxicol 2015 May 3;28(5):927-34. Epub 2015 Apr 3.

§Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, United States.

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http://dx.doi.org/10.1021/tx5005248DOI Listing
May 2015

Drug-induced rhabdomyolysis: from systems pharmacology analysis to biochemical flux.

Chem Res Toxicol 2014 Mar 28;27(3):421-32. Epub 2014 Jan 28.

Department of Neurology, University of Michigan , Ann Arbor, Michigan 48109, United States.

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http://dx.doi.org/10.1021/tx400409cDOI Listing
March 2014

Systems pharmacology modeling: an approach to improving drug safety.

Biopharm Drug Dispos 2014 Jan 20;35(1):1-14. Epub 2013 Nov 20.

Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993, USA.

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http://dx.doi.org/10.1002/bdd.1871DOI Listing
January 2014

Quantitative systems pharmacology for shifting the drug discovery and development paradigm.

Authors:
Jane P F Bai

Biopharm Drug Dispos 2013 Dec;34(9):475-6

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http://dx.doi.org/10.1002/bdd.1870DOI Listing
December 2013

Systems pharmacology to predict drug toxicity: integration across levels of biological organization.

Annu Rev Pharmacol Toxicol 2013 5;53:451-73. Epub 2012 Nov 5.

Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1146/annurev-pharmtox-011112-140248DOI Listing
July 2013

Strategic applications of gene expression: from drug discovery/development to bedside.

AAPS J 2013 Apr 15;15(2):427-37. Epub 2013 Jan 15.

Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA.

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http://ccdlab.org/paper-pdfs/aaps_2013.pdf
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http://link.springer.com/10.1208/s12248-012-9447-1
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http://dx.doi.org/10.1208/s12248-012-9447-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3675744PMC
April 2013

Strategic biomarkers for drug development in treating rare diseases and diseases in neonates and infants.

AAPS J 2013 Apr 19;15(2):447-54. Epub 2013 Jan 19.

Office of Clinical Pharmacology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.

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http://dx.doi.org/10.1208/s12248-013-9452-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3675740PMC
April 2013

Modeling and simulation of the effect of proton pump inhibitors on magnesium homeostasis. 1. Oral absorption of magnesium.

Mol Pharm 2012 Dec 2;9(12):3495-505. Epub 2012 Nov 2.

Office of Generic Drugs, Office of Pharmaceutical Science, §Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, and †Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation, Food and Drug Administration , Rockville, Maryland, United States.

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http://dx.doi.org/10.1021/mp300323qDOI Listing
December 2012

Monoclonal antibodies: from benchtop to bedside.

Authors:
Jane P F Bai

Ther Deliv 2011 Mar;2(3):329-31

Office of Clinical Pharmacology, Center for Drug Evaluation & Research, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

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March 2011

Individualizing therapy of monoclonal antibodies and fusion proteins: emerging potential in the age of personalized medicine.

Ther Deliv 2011 Mar;2(3):369-81

Office of Clinical Pharmacology, Center for Drug Evaluation & Research, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

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March 2011

Drug delivery to the brain: considerations of genetic polymorphisms of blood-brain barrier transporters and imaging technologies.

Authors:
Jane P F Bai

Ther Deliv 2010 Oct;1(4):563-70

US FDA, Silver Spring, MD 20993, USA.

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October 2010

Ongoing challenges in drug interaction safety: from exposure to pharmacogenomics.

Authors:
Jane P F Bai

Drug Metab Pharmacokinet 2010 ;25(1):62-71

Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA.

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June 2010

Understanding the genetic basis for adverse drug effects: the calcineurin inhibitors.

Pharmacotherapy 2010 Feb;30(2):195-209

Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1592/phco.30.2.195DOI Listing
February 2010

Use of classification regression tree in predicting oral absorption in humans.

J Chem Inf Comput Sci 2004 Nov-Dec;44(6):2061-9

ZyxBio, LLC, PO Box 2255, Hudson, Ohio 44236, USA.

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http://dx.doi.org/10.1021/ci040023nDOI Listing
November 2005