Peter A Lachenbruch

Peter A Lachenbruch

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Peter A Lachenbruch

Peter A Lachenbruch

Publications by authors named "Peter A Lachenbruch"

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37Publications

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Scientific factors and current issues in biosimilar studies.

J Biopharm Stat 2014 ;24(6):1138-53

a Department of Biostatistics and Bioinformatics , School of Medicine, Duke University , Durham , North Carolina , USA.

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http://dx.doi.org/10.1080/10543406.2014.948961DOI Listing
June 2015

Comments on the FDA draft guidance on biosimilar products.

Stat Med 2013 Feb 18;32(3):364-9. Epub 2012 Aug 18.

Duke University School of Medicine, Durham, NC, U.S.A.

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http://dx.doi.org/10.1002/sim.5572DOI Listing
February 2013

Scientific considerations for assessing biosimilar products.

Stat Med 2013 Feb 30;32(3):370-81. Epub 2012 Aug 30.

Duke University School of Medicine, Durham, NC, U.S.A.

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http://doi.wiley.com/10.1002/sim.5571
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http://dx.doi.org/10.1002/sim.5571DOI Listing
February 2013

Variable selection when missing values are present: a case study.

Stat Methods Med Res 2011 Aug 4;20(4):429-44. Epub 2010 May 4.

Department of Public Health, Oregon State University, Corvallis, OR, USA.

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http://dx.doi.org/10.1177/0962280209358003DOI Listing
August 2011

Guest authorship, mortality reporting, and integrity in rofecoxib studies.

JAMA 2008 Aug;300(8):904; author reply 905-6

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http://dx.doi.org/10.1001/jama.300.8.904-aDOI Listing
August 2008

Alternative scoring of the Cutaneous Assessment Tool in juvenile dermatomyositis: results using abbreviated formats.

Arthritis Rheum 2008 Mar;59(3):352-6

Izaak Walton Killam Health Centre and Dalhousie University, Halifax, Nova Scotia, Canada.

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http://dx.doi.org/10.1002/art.23313DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2598766PMC
March 2008

Developing international consensus on measures of improvement for patients with myositis.

Stat Methods Med Res 2007 Feb;16(1):51-64

FDA Center for Biologics Evaluation and Research, USA.

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http://dx.doi.org/10.1177/0962280206070652DOI Listing
February 2007

Quantification of hepatitis B virus genomes and infectivity in human serum samples.

Transfusion 2006 Oct;46(10):1829-35

Division of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Bethesda, Maryland, USA.

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http://dx.doi.org/10.1111/j.1537-2995.2006.00974.xDOI Listing
October 2006

Some aspects of the application of internal pilot studies.

Biom J 2006 Aug;48(4):556-7; discussion 558

US Food and Drug Administration, USA.

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http://dx.doi.org/10.1002/bimj.200610243DOI Listing
August 2006

Opening the adaptive toolbox.

Biom J 2006 Aug;48(4):598-603; discussion 613-22

Statistics Collaborative, 1625 Massachusetts Ave., NW, Washington, DC 20036, USA.

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http://dx.doi.org/10.1002/bimj.200610240DOI Listing
August 2006

Potential use of the scan statistic for quality control in blood product manufacturing.

J Biopharm Stat 2005 ;15(2):353-66

Division of Biostatistics, FDA/CBER/OBE, Rockville, MD 20852, USA.

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http://dx.doi.org/10.1081/BIP-200048790DOI Listing
July 2005

Preventive vaccines against bioterrorism: evaluation of efficacy and safety.

Vaccine 2004 Nov;23(1):84-90

Division of Biostatistics, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research (CBER), FDA, HFM-217, 1401 Rockville Pike, Rockville, MD 20852-1448, USA.

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http://dx.doi.org/10.1016/j.vaccine.2004.04.037DOI Listing
November 2004

Fatalities caused by TRALI.

Transfus Med Rev 2004 Jul;18(3):184-8

Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA.

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http://dx.doi.org/10.1016/j.tmrv.2004.03.004DOI Listing
July 2004

International consensus on preliminary definitions of improvement in adult and juvenile myositis.

Arthritis Rheum 2004 Jul;50(7):2281-90

National Institute of Environmental Health Sciences, NIH, Bethesda, Maryland 20892, USA.

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http://dx.doi.org/10.1002/art.20349DOI Listing
July 2004

Biomarkers and surrogate endpoints in renal transplantation: present status and considerations for clinical trial design.

Am J Transplant 2004 Apr;4(4):451-7

Division of Biostatistics, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Rockville, MD, USA.

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http://doi.wiley.com/10.1111/j.1600-6143.2004.00386.x
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http://dx.doi.org/10.1111/j.1600-6143.2004.00386.xDOI Listing
April 2004

Proper metrics for clinical trials: transformations and other procedures to remove non-normality effects.

Stat Med 2003 Dec;22(24):3823-42

FDA/CBER/Office of Biostatistics and Epidemiology, 1401 Rockville Pike, HFM-215, Rockville, MD 20852, USA.

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http://dx.doi.org/10.1002/sim.1675DOI Listing
December 2003

Defining Clinical Improvement in Adult and Juvenile Myositis.

J Rheumatol 2003 Mar;30(3):603-17

Enviromental Autoimmunity Group, National Institute of Enviromental Health Sciences, National Institutes of Health, Bethesda, MD 20892, USA.

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March 2003

Neopterin and quinolinic acid are surrogate measures of disease activity in the juvenile idiopathic inflammatory myopathies.

Clin Chem 2002 Oct;48(10):1681-8

Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA.

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October 2002

Analysis of data with excess zeros.

Stat Methods Med Res 2002 Aug;11(4):297-302

FDA Center for Biologics Research and Review, Office of Biostatistics and Epidemiology, Rockville, MD, USA.

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http://dx.doi.org/10.1191/0962280202sm289raDOI Listing
August 2002