Michael P Fay

Michael P Fay

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Michael P Fay

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Analysis of ordered composite endpoints.

Stat Med 2020 Feb 19;39(5):602-616. Epub 2019 Dec 19.

Department of Biostatistics & Bioinformatics, George Washington University, Washington, District of Columbia.

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http://dx.doi.org/10.1002/sim.8431DOI Listing
February 2020

Hypereosinophilic Syndrome Subtype Predicts Responsiveness to Glucocorticoids.

J Allergy Clin Immunol Pract 2018 Jan - Feb;6(1):190-195. Epub 2017 Jul 27.

Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Bethesda, Md.

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http://dx.doi.org/10.1016/j.jaip.2017.06.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5760470PMC
October 2019

Strong concordance between percent inhibition in oocyst and sporozoite intensities in a Plasmodium falciparum standard membrane-feeding assay.

Parasit Vectors 2019 May 6;12(1):206. Epub 2019 May 6.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 12735 Twinbrook Parkway, Rockville, MD, 20852, USA.

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http://dx.doi.org/10.1186/s13071-019-3470-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6501457PMC
May 2019

Benralizumab for -Negative Hypereosinophilic Syndrome.

N Engl J Med 2019 04;380(14):1336-1346

From the Laboratory of Parasitic Diseases (F.L.K., F.L., M.M., J.W., L.W., T.B., T.M., B.P., P.Y., P.K., A.D.K.) and Biostatistics Research Branch (M.P.F.), National Institute of Allergy and Infectious Diseases, the Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (H.A., S.K.), and the Laboratory of Pathology, National Cancer Institute (A.P., M.Q.), National Institutes of Health (NIH), and the Departments of Laboratory Medicine (J.H.E., X.S., I.M.) and Transfusion Medicine (S.R.P.), NIH Clinical Center, Bethesda, Washington Adventist Hospital, Takoma Park (T.M.), and MedImmune (N.L., R.K.) and AstraZeneca (P.N., M.G.), Gaithersburg - all in Maryland; the Department of Veteran Affairs, Tennessee Valley Healthcare System, Chattanooga (J.H.E.); and MedImmune, South San Francisco, CA (L.Y.).

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http://dx.doi.org/10.1056/NEJMoa1812185DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6557265PMC
April 2019

Confidence intervals of the Mann-Whitney parameter that are compatible with the Wilcoxon-Mann-Whitney test.

Stat Med 2018 11 8;37(27):3991-4006. Epub 2018 Jul 8.

Department of Mathematics and Statistics, University of Maryland, Baltimore County, Baltimore, Maryland.

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http://dx.doi.org/10.1002/sim.7890DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6377068PMC
November 2018

Causal estimands and confidence intervals associated with Wilcoxon-Mann-Whitney tests in randomized experiments.

Stat Med 2018 09 17;37(20):2923-2937. Epub 2018 May 17.

Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden.

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http://dx.doi.org/10.1002/sim.7799DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373726PMC
September 2018

Statistical Methods for Standard Membrane-Feeding Assays to Measure Transmission Blocking or Reducing Activity in Malaria.

J Am Stat Assoc 2018 12;113(522):534-545. Epub 2018 Jun 12.

National Institute of Allergy and Infectious Diseases, Laboratory of Malaria and Vector Research, National Institutes of Health, Rockville, MD.

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http://dx.doi.org/10.1080/01621459.2017.1356313DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6469714PMC
June 2018

Response to letter by Antonio Martín Andrés on "A boundary-optimized rejection region test for the two-sample binomial problem".

Stat Med 2018 06;37(14):2303-2306

Biostatistics Research Branch NIAID NIH Rockville, MD, USA.

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http://dx.doi.org/10.1002/sim.7684DOI Listing
June 2018

A boundary-optimized rejection region test for the two-sample binomial problem.

Stat Med 2018 03 26;37(7):1047-1058. Epub 2017 Dec 26.

Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.

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http://dx.doi.org/10.1002/sim.7579DOI Listing
March 2018

Measuring precision in bioassays: Rethinking assay validation.

Stat Med 2018 02 19;37(4):519-529. Epub 2017 Oct 19.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.

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http://dx.doi.org/10.1002/sim.7528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5771887PMC
February 2018

Pearson's chi-square test and rank correlation inferences for clustered data.

Biometrics 2017 09 9;73(3):822-834. Epub 2017 Feb 9.

Biostatistics Research Branch National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 20852, U.S.A.

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http://dx.doi.org/10.1111/biom.12653DOI Listing
September 2017

Confidence intervals for directly standardized rates using mid-p gamma intervals.

Biom J 2017 Mar 23;59(2):377-387. Epub 2016 Dec 23.

National Institute of Allergy and Infectious Diseases, Biostatistics Research Branch, 5601 Fishers Lane, Bethesda, MD, 20892-9820, USA.

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http://dx.doi.org/10.1002/bimj.201600111DOI Listing
March 2017

Non-inferiority tests for anti-infective drugs using control group quantiles.

Clin Trials 2016 12 17;13(6):632-640. Epub 2016 Jul 17.

Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.

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http://dx.doi.org/10.1177/1740774516654861DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5133167PMC
December 2016

A rank test for bivariate time-to-event outcomes when one event is a surrogate.

Stat Med 2016 08 5;35(19):3413-23. Epub 2016 Apr 5.

Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, U.S.A.

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http://dx.doi.org/10.1002/sim.6950DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4938716PMC
August 2016

Finite sample pointwise confidence intervals for a survival distribution with right-censored data.

Stat Med 2016 07 18;35(16):2726-40. Epub 2016 Feb 18.

National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, MSC 9820, Bethesda, MD 20892, U.S.A.

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http://dx.doi.org/10.1002/sim.6905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4899279PMC
July 2016

Transmission-blocking activity is determined by transmission-reducing activity and number of control oocysts in Plasmodium falciparum standard membrane-feeding assay.

Vaccine 2016 07 29;34(35):4145-4151. Epub 2016 Jun 29.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 12735 Twinbrook Parkway, Rockville, MD 20852, USA.

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http://dx.doi.org/10.1016/j.vaccine.2016.06.066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4958521PMC
July 2016

Dihydroartemisinin-piperaquine resistance in Plasmodium falciparum malaria in Cambodia: a multisite prospective cohort study.

Lancet Infect Dis 2016 Mar 8;16(3):357-65. Epub 2016 Jan 8.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA. Electronic address:

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http://dx.doi.org/10.1016/S1473-3099(15)00487-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4792715PMC
March 2016

Ex-vivo cytoadherence phenotypes of Plasmodium falciparum strains from Malian children with hemoglobins A, S, and C.

PLoS One 2014 19;9(3):e92185. Epub 2014 Mar 19.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0092185PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3960211PMC
December 2015

Artemisinin-resistant Plasmodium falciparum clinical isolates can infect diverse mosquito vectors of Southeast Asia and Africa.

Nat Commun 2015 Oct 20;6:8614. Epub 2015 Oct 20.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 12735 Twinbrook Parkway, Rockville, Maryland 20852, USA.

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http://dx.doi.org/10.1038/ncomms9614DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4616032PMC
October 2015

Bayesian hierarchical regression on clearance rates in the presence of "lag" and "tail" phases with an application to malaria parasites.

Biometrics 2015 Sep 7;71(3):751-9. Epub 2015 Apr 7.

Department of Statistics, The Wharton School, University of Pennsylvania, Philadelphia, Pennsylvania 19104, U.S.A.

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http://dx.doi.org/10.1111/biom.12307DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4575239PMC
September 2015

Incidence of active pulmonary tuberculosis in patients with coincident filarial and/or intestinal helminth infections followed longitudinally in South India.

PLoS One 2014 11;9(4):e94603. Epub 2014 Apr 11.

Helminth Immunology Section, Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0094603PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3984271PMC
May 2015

Combining one-sample confidence procedures for inference in the two-sample case.

Biometrics 2015 Mar 1;71(1):146-156. Epub 2014 Oct 1.

National Institute of Allergy and Infectious Diseases, 6700B Rockledge Dr. MSC 7630, Bethesda, Maryland, 20892-7630, U.S.A.

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http://dx.doi.org/10.1111/biom.12231DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4852749PMC
March 2015

Treatment of W. bancrofti (Wb) in HIV/Wb coinfections in South India.

PLoS Negl Trop Dis 2015 Mar 20;9(3):e0003622. Epub 2015 Mar 20.

Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.

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http://dx.doi.org/10.1371/journal.pntd.0003622DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4368731PMC
March 2015

Effect of ingested human antibodies induced by RTS, S/AS01 malaria vaccination in children on Plasmodium falciparum oocyst formation and sporogony in mosquitoes.

Malar J 2014 Jul 9;13:263. Epub 2014 Jul 9.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 12735 Twinbrook Parkway, Rockville, MD 20852, USA.

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http://dx.doi.org/10.1186/1475-2875-13-263DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4100490PMC
July 2014

Functional comparison of Plasmodium falciparum transmission-blocking vaccine candidates by the standard membrane-feeding assay.

Infect Immun 2013 Dec 16;81(12):4377-82. Epub 2013 Sep 16.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.

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http://dx.doi.org/10.1128/IAI.01056-13DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3838000PMC
December 2013

Qualification of standard membrane-feeding assay with Plasmodium falciparum malaria and potential improvements for future assays.

PLoS One 2013 6;8(3):e57909. Epub 2013 Mar 6.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Rockville, MD, USA.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0057909PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3590281PMC
September 2013

Pointwise confidence intervals for a survival distribution with small samples or heavy censoring.

Biostatistics 2013 Sep 30;14(4):723-36. Epub 2013 Apr 30.

National Institute of Allergy and Infectious Diseases, 6700B Rockledge Dr. MSC 7630, Bethesda, MD 20892-7630, USA.

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http://dx.doi.org/10.1093/biostatistics/kxt016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3769999PMC
September 2013

Phase 1 study in malaria naïve adults of BSAM2/Alhydrogel®+CPG 7909, a blood stage vaccine against P. falciparum malaria.

PLoS One 2012 4;7(10):e46094. Epub 2012 Oct 4.

Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIAID/NIH), Rockville, Maryland, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0046094PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3464250PMC
April 2013

Delayed-type hypersensitivity to sand fly saliva in humans from a leishmaniasis-endemic area of Mali is Th1-mediated and persists to midlife.

J Invest Dermatol 2013 Feb 20;133(2):452-9. Epub 2012 Sep 20.

Vector Molecular Biology Section, Laboratory of Malaria and Vector Research (LMVR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rockville, Maryland, USA.

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http://dx.doi.org/10.1038/jid.2012.315DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3529997PMC
February 2013

Weighted logrank tests for interval censored data when assessment times depend on treatment.

Stat Med 2012 Dec 11;31(28):3760-72. Epub 2012 Jul 11.

National Institute of Allergy and Infectious Diseases, 6700-B Rockledge Dr, MSC 7630, Bethesda, MD 20892-7630, USA.

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http://dx.doi.org/10.1002/sim.5447DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4029411PMC
December 2012

Circulating microbial products and acute phase proteins as markers of pathogenesis in lymphatic filarial disease.

PLoS Pathog 2012 7;8(6):e1002749. Epub 2012 Jun 7.

National Institutes of Health, International Center for Excellence in Research, Chennai, India.

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http://dx.doi.org/10.1371/journal.ppat.1002749DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3369944PMC
November 2012

A valid formulation of the analysis of noninferiority trials under random effects meta-analysis.

Biostatistics 2012 Sep 30;13(4):637-49. Epub 2012 Mar 30.

Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892-7630, USA.

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http://dx.doi.org/10.1093/biostatistics/kxs006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3658490PMC
September 2012

Anthrax vaccine-induced antibodies provide cross-species prediction of survival to aerosol challenge.

Sci Transl Med 2012 Sep;4(151):151ra126

Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive, Bethesda, MD 20892-7630, USA.

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http://dx.doi.org/10.1126/scitranslmed.3004073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668972PMC
September 2012

IL-5 receptor α levels in patients with marked eosinophilia or mastocytosis.

J Allergy Clin Immunol 2011 Nov 16;128(5):1086-92.e1-3. Epub 2011 Jul 16.

Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.

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http://dx.doi.org/10.1016/j.jaci.2011.05.032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3205313PMC
November 2011

Infection parameters in the sand fly vector that predict transmission of Leishmania major.

PLoS Negl Trop Dis 2011 Aug 23;5(8):e1288. Epub 2011 Aug 23.

Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.

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http://dx.doi.org/10.1371/journal.pntd.0001288DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3160291PMC
August 2011

Immunological responses against Plasmodium falciparum Apical Membrane Antigen 1 vaccines vary depending on the population immunized.

Vaccine 2011 Mar 31;29(12):2255-61. Epub 2011 Jan 31.

Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA.

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http://dx.doi.org/10.1016/j.vaccine.2011.01.043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3046304PMC
March 2011

Anaemia in a phase 2 study of a blood stage falciparum malaria vaccine.

Malar J 2011 Jan 19;10:13. Epub 2011 Jan 19.

Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIAID/NIH), Rockville, Maryland, USA.

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http://dx.doi.org/10.1186/1475-2875-10-13DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3036666PMC
January 2011

Exact and Asymptotic Weighted Logrank Tests for Interval Censored Data: The interval R package.

J Stat Softw 2010 Aug;36(2)

National Institute of Allergy and Infectious Diseases.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4184046PMC
http://dx.doi.org/10.18637/jss.v036.i02DOI Listing
August 2010

The IC(50) of anti-Pfs25 antibody in membrane-feeding assay varies among species.

Vaccine 2010 Jun 29;28(27):4423-9. Epub 2010 Apr 29.

National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA.

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http://dx.doi.org/10.1016/j.vaccine.2010.04.036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2880321PMC
June 2010

Confidence intervals that match Fisher's exact or Blaker's exact tests.

Authors:
Michael P Fay

Biostatistics 2010 Apr 30;11(2):373-4. Epub 2009 Nov 30.

Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892-7609, USA.

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http://dx.doi.org/10.1093/biostatistics/kxp050DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2852239PMC
April 2010

Phase 1 safety and immunogenicity trial of the Plasmodium falciparum blood-stage malaria vaccine AMA1-C1/ISA 720 in Australian adults.

Vaccine 2010 Mar 4;28(10):2236-2242. Epub 2010 Jan 4.

Malaria Vaccine Development Branch (MVDB), National Institute of Allergy and Infectious Disease, National Institutes of Health (NIAID/NIH), Rockville, MD, United States.

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http://dx.doi.org/10.1016/j.vaccine.2009.12.049DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2847846PMC
March 2010

Geographic patterns of Plasmodium falciparum drug resistance distinguished by differential responses to amodiaquine and chloroquine.

Proc Natl Acad Sci U S A 2009 Nov 2;106(45):18883-9. Epub 2009 Nov 2.

Laboratory of Malaria and Vector Research and Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1073/pnas.0911317106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2771746PMC
November 2009

Chop-lump tests for vaccine trials.

Biometrics 2009 Sep 5;65(3):885-93. Epub 2009 Feb 5.

Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, MSC 7609, Bethesda, Maryland 20892, USA.

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http://dx.doi.org/10.1111/j.1541-0420.2008.01131.xDOI Listing
September 2009

Robust Non-inferiority Tests for Potency of a Test Drug Against a Reference Drug: (To appear in Statistics in Biopharmaceutical Research ).

Stat Biopharm Res 2009 Aug;1(3):291-300

Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive MSC 7609, Bethesda, Maryland 20892-7609. (email: ).

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http://dx.doi.org/10.1198/sbr.2009.0023.DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2739393PMC
August 2009

A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel with CPG 7909, using two different formulations and dosing intervals.

Vaccine 2009 Jun 15;27(31):4104-9. Epub 2009 May 15.

Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Twinbrook I, MD 20852, USA.

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http://dx.doi.org/10.1016/j.vaccine.2009.04.077DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2722923PMC
June 2009

Disruption of a Plasmodium falciparum multidrug resistance-associated protein (PfMRP) alters its fitness and transport of antimalarial drugs and glutathione.

J Biol Chem 2009 Mar 31;284(12):7687-96. Epub 2008 Dec 31.

Laboratory of Malaria and Vector Research, Research Technologies Branch, and Biostatistical Research Branch, NIAID, National Institutes of Health, Bethesda, Maryland 20892-8132, USA.

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http://dx.doi.org/10.1074/jbc.M806944200DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2658063PMC
March 2009

Phase 1 trial of AMA1-C1/Alhydrogel plus CPG 7909: an asexual blood-stage vaccine for Plasmodium falciparum malaria.

PLoS One 2008 Aug 13;3(8):e2940. Epub 2008 Aug 13.

Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0002940PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2491586PMC
August 2008

Changes in the plasmodial surface anion channel reduce leupeptin uptake and can confer drug resistance in Plasmodium falciparum-infected erythrocytes.

Antimicrob Agents Chemother 2008 Jul 28;52(7):2346-54. Epub 2008 Apr 28.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland 20892, USA.

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http://dx.doi.org/10.1128/AAC.00057-08DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2443925PMC
July 2008

Quantification of the infectious dose of Leishmania major transmitted to the skin by single sand flies.

Proc Natl Acad Sci U S A 2008 Jul 14;105(29):10125-30. Epub 2008 Jul 14.

Laboratories of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.

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http://www.pnas.org/cgi/doi/10.1073/pnas.0802331105
Publisher Site
http://dx.doi.org/10.1073/pnas.0802331105DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2481378PMC
July 2008

Monitoring rare serious adverse events from a new treatment and testing for a difference from historical controls.

Clin Trials 2007 ;4(6):598-610

Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive, Bethesda, MD 20892-7609, USA.

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http://dx.doi.org/10.1177/1740774507084978DOI Listing
March 2008

On Using Truncated Sequential Probability Ratio Test Boundaries for Monte Carlo Implementation of Hypothesis Tests.

J Comput Graph Stat 2007 ;16(4):946-967

National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive MSC 7609, Bethesda, MD 20892-7609.

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http://dx.doi.org/10.1198/106186007X257025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2467508PMC
January 2007