Publications by authors named "Lynne Yao"

32Publications

Creatinine-Based Renal Function Assessment in Pediatric Drug Development: An Analysis Using Clinical Data for Renally Eliminated Drugs.

Clin Pharmacol Ther 2020 Jul 22. Epub 2020 Jul 22.

Office of Drug Evaluation IV, Office of New Drugs, 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/cpt.1991DOI Listing
July 2020

Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018.

Clin Pharmacol Ther 2020 Nov 22;108(5):1018-1025. Epub 2020 Jun 22.

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/cpt.1886DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7572516PMC
November 2020

Exposure-Response Assessment in Pediatric Drug Development Studies Submitted to the US Food and Drug Administration.

Clin Pharmacol Ther 2020 Jul 16;108(1):90-98. Epub 2020 Mar 16.

Office of Drug Evaluation IV, Office of New Drugs, 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/cpt.1809DOI Listing
July 2020

Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology.

Clin Pharmacol Ther 2020 04 26;107(4):707-709. Epub 2020 Jan 26.

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/cpt.1763DOI Listing
April 2020

Protecting Pregnant Women With Substance Use Disorders and Their Neonates Participating in Research.

JAMA 2019 Jul 12. Epub 2019 Jul 12.

Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2019.9002DOI Listing
July 2019

Collaboration in Regulatory Science to Facilitate Therapeutic Development for Pregnant Women.

Curr Pharm Des 2019 ;25(5):609-614

Food and Drug Administration: 10903 New Hampshire Ave, Silver Spring, MD, United States.

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http://dx.doi.org/10.2174/1381612825666190328112202DOI Listing
February 2020

Renal Clearance in Newborns and Infants: Predictive Performance of Population-Based Modeling for Drug Development.

Clin Pharmacol Ther 2019 06 10;105(6):1462-1470. Epub 2019 Feb 10.

Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, 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/cpt.1332DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6513721PMC
June 2019

Paediatric extrapolation: A necessary paradigm shift.

Br J Clin Pharmacol 2019 04 18;85(4):675-679. Epub 2018 Dec 18.

Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, USA.

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http://doi.wiley.com/10.1111/bcp.13809
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http://dx.doi.org/10.1111/bcp.13809DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6422664PMC
April 2019

Bone Mineral Density to Assess Pediatric Bone Health in Drug Development.

Ther Innov Regul Sci 2017 Nov 11;51(6):756-760. Epub 2017 May 11.

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

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http://dx.doi.org/10.1177/2168479017709047DOI Listing
November 2017

Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.

Clin Pharmacol Ther 2019 03 9;105(3):555-557. Epub 2018 Aug 9.

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/cpt.1117DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6481930PMC
March 2019

Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA.

J Clin Pharmacol 2018 07 17;58(7):885-890. Epub 2018 Apr 17.

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

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http://dx.doi.org/10.1002/jcph.1109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6112107PMC
July 2018

Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.

Clin Pharmacol Ther 2018 11 13;104(5):983-988. Epub 2018 Feb 13.

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/cpt.971DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6441612PMC
November 2018

Development of Drug Therapies for Newborns and Children: The Scientific and Regulatory Imperatives.

Pediatr Clin North Am 2017 12;64(6):1185-1196

Division of Pediatric and Maternal Health, CDER US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.

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http://dx.doi.org/10.1016/j.pcl.2017.08.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5765998PMC
December 2017

Neonatal Safety Information Reported to the FDA During Drug Development Studies.

Ther Innov Regul Sci 2017 28;2017:1-9. Epub 2017 Jun 28.

Office of Drug Evaluation IV, CDER, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1177/2168479017716713DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5549935PMC
June 2017

Glomerular Diseases: Registries and Clinical Trials.

Clin J Am Soc Nephrol 2016 12 26;11(12):2234-2243. Epub 2016 Sep 26.

Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.

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http://dx.doi.org/10.2215/CJN.00540116DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5142054PMC
December 2016

Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.

J Clin Pharmacol 2016 11;56(11):1326-1334

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

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http://dx.doi.org/10.1002/jcph.744DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5482171PMC
November 2016

Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products.

Birth Defects Res A Clin Mol Teratol 2015 Aug 27;103(8):718-20. Epub 2015 Jul 27.

Division of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1002/bdra.23403DOI Listing
August 2015

Adverse Event Detection and Labeling in Pediatric Drug Development: Antiretroviral Drugs.

Ther Innov Regul Sci 2015 Mar;49(2):302-309

4 Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1177/2168479014565471DOI Listing
March 2015

Defining new surrogate markers for CKD progression.

Pediatr Nephrol 2015 Feb 5;30(2):193-8. Epub 2014 Nov 5.

Department of Pediatrics, Northwestern University Feinberg School of Medicine, Morton Building Room 4-685G, 320 E. Superior, Chicago, IL, 60611, USA,

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http://dx.doi.org/10.1007/s00467-014-2995-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282962PMC
February 2015

Drug development for pediatric neurogenic bladder dysfunction: dosing, endpoints, and study design.

J Clin Pharmacol 2014 Nov 24;54(11):1239-46. Epub 2014 Jun 24.

Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, CA.

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http://dx.doi.org/10.1002/jcph.345DOI Listing
November 2014

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

The role of immune tolerance induction in restoration of the efficacy of ERT in Pompe disease.

Am J Med Genet C Semin Med Genet 2012 Feb 17;160C(1):30-9. Epub 2012 Jan 17.

Office of Pharmaceutical Science, Office of Biotechnology Products, Division of Therapeutic Proteins, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1002/ajmg.c.31316DOI Listing
February 2012

Extrapolation of adult data and other data in pediatric drug-development programs.

Pediatrics 2011 Nov 24;128(5):e1242-9. Epub 2011 Oct 24.

Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1542/peds.2010-3487DOI Listing
November 2011

Management patterns of childhood-onset nephrotic syndrome.

Pediatr Nephrol 2009 Nov 12;24(11):2193-201. Epub 2009 Aug 12.

University of North Carolina at Chapel Hill, 27599-7155, USA.

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http://dx.doi.org/10.1007/s00467-009-1282-yDOI Listing
November 2009

Management of childhood onset nephrotic syndrome.

Pediatrics 2009 Aug 27;124(2):747-57. Epub 2009 Jul 27.

Division of Nephrology and Hypertension, Department ofMedicine and Pediatrics, University of North Carolina, ChapelHill, North Carolina 27599-7155, USA.

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http://pediatrics.aappublications.org/content/pediatrics/124
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http://pediatrics.aappublications.org/cgi/doi/10.1542/peds.2
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http://dx.doi.org/10.1542/peds.2008-1559DOI Listing
August 2009