Sam Haidar

Sam Haidar

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Sam Haidar

Sam Haidar

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Regulatory efforts in response to a decade of scientific advancement in bioanalytical methods.

Authors:
Sam H Haidar

Bioanalysis 2019 Apr 4;11(7):583-586. Epub 2019 Apr 4.

US Food & Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.

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http://dx.doi.org/10.4155/bio-2019-0034DOI Listing
April 2019

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Bioanalysis 2018 Nov 29. Epub 2018 Nov 29.

Amador Bioscience, Pleasanton, CA, USA (formerly of OncoMed, Redwood City, CA, USA).

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http://dx.doi.org/10.4155/bio-2018-0287DOI Listing
November 2018

Bioanalytical inspections: organizational changes and regulatory perspectives.

Bioanalysis 2016 May 15;8(10):999-1002. Epub 2016 Apr 15.

US Food & Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.

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http://dx.doi.org/10.4155/bio-2016-0052DOI Listing
May 2016

Orally administered colony stimulating factor 1 receptor inhibitor PLX3397 in recurrent glioblastoma: an Ivy Foundation Early Phase Clinical Trials Consortium phase II study.

Neuro Oncol 2016 Apr 8;18(4):557-64. Epub 2015 Oct 8.

University of California at San Francisco, San Francisco, California (N.B., A.P., J.P., A.M.M, M.P.); Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah (H.C.); The University of Texas MD Anderson Cancer Center, Houston, Texas (J.F.D.G.); Department of Neurology, Memorial Sloan Kettering Cancer Hospital, New York, New York (A.M.O.); Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (L.N., P.Y.W., S.H., K.L.L.); UCLA Medical Center, Los Angeles, California (T.F.C.); Plexxikon Inc., Berkeley, California (A.M., B.L.W., K.B.N., H.H.H.); Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts (K.L.L.); Department of Pathology, Memorial Sloan Kettering Cancer Hospital, New York, New York (J.H.).

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http://dx.doi.org/10.1093/neuonc/nov245DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4799682PMC
April 2016

Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir.

J Pharm Sci 2016 Feb 12;105(2):996-1005. Epub 2016 Jan 12.

Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland 21201. Electronic address:

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http://dx.doi.org/10.1002/jps.24643DOI Listing
February 2016

Clinical implementation of integrated whole-genome copy number and mutation profiling for glioblastoma.

Neuro Oncol 2015 Oct 9;17(10):1344-55. Epub 2015 Mar 9.

Center for Molecular Oncologic Pathology, Dana-Farber Cancer Institute, Boston, Massachusetts (S.H.R., L.A.R., S.H., D.K., Y.J.K., K.L.L.); Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts (S.E.S., L.B., M.B., D.A.R., E.Q.L., M.L.R., A.D.N., L.N., S.R., L.M.D., D.C.L., P.K., B.J.R., P.Y.W., R.B., K.L.L.); Department of Neurosurgery, Brigham and Women's Hospital, Boston, Massachusetts (W.L.B., E.B.C, O.A.-M., M.D.J., A.J.G., I.F.D., E.A.C.); Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts (L.T.); Department of Radiation Oncology, Brigham and Women's Hospital, Boston, Massachusetts (M.H., A.A.A., N.D.A., B.M.A.); Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts (M.H., A.A.A., N.D.A., B.M.A.); Harvard Radiation Oncology Program, Boston, Massachusetts (A.R.); Kravis Center for Molecular Oncology & Department of Epidemiology and Biostatistics, Memorial Sloan- Kettering Cancer Center, New York, New York (N.S.); Broad Institute, Cambridge, Massachusetts (R.B.); Department of Pathology, Boston Children's Hospital, Boston, Massachusetts (K.L.L.); Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts (S.H.R., A.D., J.B.C., M.A., S.S., R.D.F., N.I.L., A.H.L., K.L.L.)

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http://dx.doi.org/10.1093/neuonc/nov015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4578577PMC
October 2015

Prominin-1 (CD133) defines both stem and non-stem cell populations in CNS development and gliomas.

PLoS One 2014 3;9(9):e106694. Epub 2014 Sep 3.

Center for Molecular Oncologic Pathology, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, United States of America; Department of Pathology, Boston Children's Hospital, Boston, Massachusetts, United States of America; Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts, United States of America; Department of Pathology, Harvard Medical School, Boston, Massachusetts, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0106694PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4153667PMC
May 2015

Phase II trial of sunitinib for recurrent and progressive atypical and anaplastic meningioma.

Neuro Oncol 2015 Jan 6;17(1):116-21. Epub 2014 Aug 6.

Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, New York (T.J.K., S.K., A.B.L., C.P.N., L.M.D., I.G., L.E.A., A.O.); Center for Neuro-Oncology, Dana-Farber Cancer Institute/Brigham and Women's Center, Boston, Massachusetts (P.W., K.L., S.H., A.N., J.D., E.Q.L.); Department of Neurology, University of Virginia, Charlottesville, Virginia (D.S., B.P.); Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts (S.R.P., T.B.).

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http://dx.doi.org/10.1093/neuonc/nou148DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4483051PMC
January 2015

Phase II study of monthly pasireotide LAR (SOM230C) for recurrent or progressive meningioma.

Neurology 2015 Jan 19;84(3):280-6. Epub 2014 Dec 19.

From the Division of Cancer Neurology, Department of Neurology (A.D.N., E.Q.L., P.Y.W.), and Departments of Pathology (K.L.L.) and Medicine (R.B.), Brigham and Women's Hospital, Boston, MA; Center for Neuro-Oncology (A.D.N., S.N.H., D.A.R., R.B., E.Q.L., L.D., D.L., M.G., K.H.S., C.M., P.Y.W.), Dana-Farber/Brigham and Women's Cancer Center; Department of Medicine (R.B.), Harvard Medical School (A.D.N., K.L.L., D.A.R., T.T.B., S.R.P., E.T.W., R.B., E.Q.L., P.Y.W.), Boston; Department of Medical Oncology, Center for Molecular Oncologic Pathology (K.L.L., S.H.), and Departments of Medical Oncology and Cancer Biology (R.B.), Dana-Farber Cancer Institute, Boston; Massachusetts General Hospital Biostatistics Center (A.M.); Brain Tumor Center (T.J.K.), Memorial Sloan-Kettering Cancer Center, New York, NY; Pappas Center for Neuro-Oncology (T.T.B., S.R.P.), Massachusetts General Hospital, Boston; Department of Neurology (J.J.R.), Northwestern University Feinberg School of Medicine, Chicago, IL; Brain Tumor Center (E.T.W.), Beth-Israel Deaconess Medical Center, Boston; Adult Neuro-Oncology Program (J.D.), University of Pittsburgh Medical Center, Pittsburgh, PA; Comprehensive Cancer Center (G.J.L.), Wake Forest University Baptist Medical Center, Winston-Salem, NC; and Departments of Neurosurgery and Neurology (S.P.), Cedars-Sinai Medical Center, Los Angeles, CA.

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http://dx.doi.org/10.1212/WNL.0000000000001153DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4335993PMC
January 2015

EGFR variant heterogeneity in glioblastoma resolved through single-nucleus sequencing.

Cancer Discov 2014 Aug 3;4(8):956-71. Epub 2014 Jun 3.

Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts. Center for Molecular Oncologic Pathology, Dana-Farber Cancer Institute, Boston, Massachusetts. Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts. Department of Pathology, Boston Children's Hospital, Boston, Massachusetts. Department of Pathology, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1158/2159-8290.CD-13-0879DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4125473PMC
August 2014

Pten loss in Olig2 expressing neural progenitor cells and oligodendrocytes leads to interneuron dysplasia and leukodystrophy.

Stem Cells 2014 Jan;32(1):313-26

Department of Medical Oncology, Center for Molecular Oncologic Pathology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1002/stem.1590DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4096461PMC
January 2014

Common reasons for "for-cause" inspections in bioequivalence studies submitted to the Food and Drug Administration.

AAPS J 2013 Jan 28;15(1):10-4. Epub 2012 Sep 28.

Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, USA.

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http://dx.doi.org/10.1208/s12248-012-9415-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3535114PMC
January 2013

Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.

AAPS J 2012 Dec 13;14(4):915-24. Epub 2012 Sep 13.

Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7520 Standish Place, Metro Park North One, Rockville, Maryland 20855, USA.

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http://dx.doi.org/10.1208/s12248-012-9406-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475857PMC
December 2012

Integrative functional genomics identifies RINT1 as a novel GBM oncogene.

Neuro Oncol 2012 Nov 16;14(11):1325-31. Epub 2012 Oct 16.

Department of Medical Oncology, Dana-Farber Cancer Institute, Dana-Farber Cancer Institute, Boston, MA 02215, USA.

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http://dx.doi.org/10.1093/neuonc/nos246DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3480269PMC
November 2012

Effects of commonly used excipients on the expression of CYP3A4 in colon and liver cells.

Pharm Res 2010 Aug 26;27(8):1703-12. Epub 2010 May 26.

Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, 20 Penn Street, Baltimore, Maryland 21201, USA.

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http://dx.doi.org/10.1007/s11095-010-0170-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3718039PMC
August 2010

Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.

Ann Pharmacother 2009 Oct 23;43(10):1583-97. Epub 2009 Sep 23.

Division of Bioequivalence II, Office of Generic Drugs, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Derwood, MD 20855, USA.

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http://dx.doi.org/10.1345/aph.1M141DOI Listing
October 2009

Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications.

AAPS J 2008 5;10(1):148-56. Epub 2008 Mar 5.

US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, 7520 Standish Place, Rockville, Maryland 20855, USA.

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http://pubmedcentralcanada.ca/pmcc/articles/PMC2751460/pdf/1
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http://dx.doi.org/10.1208/s12248-008-9015-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751460PMC
September 2008

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

AAPS J 2008 Sep 26;10(3):450-4. Epub 2008 Aug 26.

Office of Generic Drugs, CDER/FDA, 7519 Standish Place, HFD-600, Rockville, Maryland 20855, USA.

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http://dx.doi.org/10.1208/s12248-008-9053-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2761698PMC
September 2008

Bioequivalence approaches for highly variable drugs and drug products.

Pharm Res 2008 Jan 22;25(1):237-41. Epub 2007 Sep 22.

Office of Generic Drugs, Food and Drug Administration, 7500 Standish Place, Rockville, Maryland, 20855, USA,

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http://dx.doi.org/10.1007/s11095-007-9434-xDOI Listing
January 2008

Modeling the pharmacokinetics and pharmacodynamics of a unique oral hypoglycemic agent using neural networks.

Pharm Res 2002 Jan;19(1):87-91

Office of Clinical Pharmacology and Biopharmaceutics, FDA, Rockville, Maryland 20857, USA.

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http://dx.doi.org/10.1023/a:1013611617787DOI Listing
January 2002