Publications

  • Hampshire V. Anticoagulation therapy in animal research. Lab Anim (NY). 2016 Oct 20;45(11):431-432. doi: 10.1038/laban.1133. PubMed PMID: 27763601.
  • Hampshire V. Using the SOAP format and a minimum database with clinical chemistry. Lab Anim (NY). 2016 Jun 21;45(7):259-61. doi: 10.1038/laban.1040. PubMed PMID: 27327013.
  • Hampshire V. CRISPR/Cas9 and the future of clinical research. Lab Anim (NY). 2016 Mar;45(3):89-90. doi: 10.1038/laban.955. PubMed PMID: 26886665.
  • Hampshire V. Altered states part 2: addressing nausea in canine research subjects. Lab Anim (NY). 2016 Feb;45(2):61-2. doi: 10.1038/laban.931. PubMed PMID: 26814351.
  • Hampshire V. Altered states part 1: ancillary refinements in managing perioperative distress with canines. Lab Anim (NY). 2016 Jan;45(1):17-8. doi: 10.1038/laban.907. PubMed PMID: 26684953.
  • Hampshire V, Robertson S. Using the facial grimace scale to evaluate rabbit wellness in post-procedural monitoring. Lab Anim (NY). 2015 Jul;44(7):259-60. doi: 10.1038/laban.806. PubMed PMID: 26091129.
  • Hampshire V, Rippy M. Optimizing research animal necropsy and histology practices. Lab Anim (NY). 2015 May;44(5):170-2. doi: 10.1038/laban.765. PubMed PMID: 25897936.
  • Hampshire V. A systematic process for physical examination in preclinical research. Lab Anim (NY). 2015 Mar;44(3):89-90. doi: 10.1038/laban.706. PubMed PMID: 25693104.
  • Hampshire VA. Evaluation of efficacy of heartworm preventive products at the FDA. Vet Parasitol. 2005 Oct 24;133(2-3):191-5. PubMed PMID: 16099105.
  • Hampshire VA, Doddy FM, Post LO, Koogler TL, Burgess TM, Batten PO, Hudson R, McAdams DR, Brown MA. Adverse drug event reports at the United States Food And Drug Administration Center for Veterinary Medicine. J Am Vet Med Assoc. 2004 Aug 15;225(4):533-6. PubMed PMID: 15344359.
  • Harvey ED: “Resolving Disputes with Your US FDA Review Team,” J Medical Device Regulation, May 2008. [view article]
  • Harvey ED: “You Have Met with the US FDA – Now What?,” J Medical Device Regulation, November 2007. [view article]
  • Harvey ED: “Successfully Interacting with the US FDA,” J Medical Device Regulation, May 2007. [view article]
  • Harvey ED, Herman WA, and Mendelson M: “Food and Drug Administration (U.S. FDA) Medical Device Research Considerations. Touch Briefing,” Drug Development, accepted for publication March 2006.
  • Harvey ED and Whang JM: “Preclinical Testing Guidelines for New Abdominopelvic Adhesion Barriers,” Infertility and Reproductive Medicine Clinics of North America, vol 14, 2003.
  • Harvey E, Oktay S, Chwirut D, and Danielson J: “How to Submit Preclinical Data to ODE,” MD&DI, July 2008. [view article]
  • Hilbert SL, Ferrans VJ, Tomita Y, Jones M: “The morphologic evaluation of explanted polyurethane trileaflet cardiac valve prostheses,” Journal of Thoracic and Cardiovascular Surgery 94:419-429, 1987.
  • Hilbert SL, Ferrans VJ, Jones M: “The Effects of Preimplantation Processing on Bioprosthetic and Biologic Cardiac Valve Morphology,” in Hopkins RA, Cardiac Reconstructions with Allograft Valves, New York, Springer-Verlag, pp 65-94, 1989.
  • Hilbert SL, Ferrans VJ, McAllister HA, Cooley DA: “Ionescu-Shiley bovine pericardial bioprostheses: histologic and ultrastructural studies,” The American Journal of Pathology 140:1195-1204, 1992.
  • Hilbert SL, Luna RE, Zhang J, Wang Y, Hopkins RA, Yu ZX, Ferrans VJ. Allograft heart valves: the role of apoptosis-mediated cell loss. Journal of Thoracic and Cardiovascular Surgery 117:454-462, 1999.
  • Hilbert SL, Schoen FJ, Jones M, Ferrans VJ: Allograft Heart Valves: Morphologic, Biomechanical and Explant Pathology Studies, in Hopkins RA, Cardiac Reconstructions with Allograft Valves (Second Edition), New York, Springer-Verlag, pp 193-231, 2004.
  • Hilbert SL and Hopkins RA in Hopkins RA: Tissue Engineered Heart Valves: The Ultimate Challenge, in Hopkins RA, Cardiac Reconstructions with Allograft Valves (Second Edition), New York, Springer-Verlag, pp 612-620, 2004.
  • Hilbert SL, Yanagida R, Souza J, Wolfinbarger L, Linthurst Jones A, Krueger P,
    Stearns, Bert A, Hopkins RA: ”Prototype anionic detergent technique used to decellularize allograft valve conduits evaluated in the right ventricular outflow tract in sheep.” Journal of Heart Valve Disease 13:831-840, 2004.
  • Quinn RW; Hilbert SL; Bert AA; Drake BW; Bustamante JA; Fenton JE; Moriarty
    SJ; Neighbors SL; Lofland GK; Hopkins RA: “Performance and Morphology of Decellularized Pulmonary Valves Implanted in Juvenile Sheep”. The Annals of Thoracic Surgery 92(1):131-137, 2011.
  • Rhodes SP, Harvey ED: “HUDs and HDEs: Common Misconceptions and Current Changes,” Regulatory Focus, Janaury 2011: 21-25. [view article]
  • Gong XY, Chwirut DJ, Mitchell MR, Choules BD: “Fatigue to Fracture: An Informative, Fast, and Reliable Approach for Assessing Medical Implant Duability,” J ASTM International, 2009; 6(7): 1-10. [view article]
  • Kaplan AV, Harvey ED, Kuntz R, Shiran H, Robb JF, and Fitzgerald P: “Humanitarian Use Devices (HUD)/Humanitarian Device Exemptions (HDE) in Cardiovascular Medicine,” Circulation, vol 112, 2005.
  • Oktay HS, Ryan T, and Chwirut DJ: “A Chronical of the U.S. Regulatory Process of Stent Approval,” in Textbook of Coronary Stenting, Eds. Stone GW and Leon MB, under development.
  • Perry M, Oktay S and Muskivitch J: “Finite Element Analysis and Fatigue of Stents,” Minim Invas Ther Allied Tech, accepted for publication.
  • Oktay S, Perry M, and Muskivitch JC: “Using Mechanical Simulations to Improve the Design of Implantable Devices,” Am J Cardiol, vol 90 (Suppl 6A), 2002.
  • Choma TJ, Chwirut DJ and Polly DW: “Biomechanics of LongSegment Fixation: Hook Patterns and Rod Strain”, J Spinal Disorders, vol 14 (2), 2001.
  • Spyker DA, Harvey ED, Harvey BE, Harvey AM, Rumack BH, Peck CC, Atkinson AJ, Woolsey RL, Abernathy DR, and Cantilena LR: “Commentaries: Assessment and Reporting of Clinical Pharmacology Information in Drug Labeling,” Clinical Pharmacology and Therapeutics, vol 67(3), 2000
  • Walsh DL, Chwirut DJ and Kotz RM: “EnvironmentalDegradation of Natural Rubber Latex Gloves: The Effects of Elevated Temperature on Tensile Strength,” ASTM J Test Eval, vol 27(6), 1999.
  • Chwirut DJ, Oktay HS and Ryan T: “Nitinol InterventionalCardiology Devices – FDA’s Perspective”, in SMST-97: Proceedings of the Second International Conference on Shape Memory and Superelastic Technologies, published by the International Organization on Shape Memory and Superelastic Technologies, 1997.
  • Johnson DM, Chwirut DJ and Regnault WF: “FDA’sRequirements for In-Vitro Performance Data for Prosthetic Heart Valves”, J Heart Valve Disease, vol 3, 1994.
  • Oktay HS, Resar J and Humphrey JD: “Luminal Gain Following Balloon Angioplasty Of Normal Coronaries With Increased Balloon Size Is Offset By Increased Arterial Recoil,” American College of Cardiology, 43rd Annual Scientific Session, 1993.
  • Oktay HS, Resar J and Humphrey JD: “Mechanics of conventional and thermal balloon angioplasty,” Bioengineering Conference, Colorado. ASME, New York, BED-Vol.24,1993.
  • Oktay HS et al, “Changes in the mechanical behavior of arteries following balloon angioplasty,” Biomechanics Symposium, Eds. RL Spilker and MH Friedman, ASME, New York, 1991.
  • Kien GA, Jeffries B, Katz HV, Herman BA, Carey RF,Chwirut DJ, and Bushar HF: “Digital Acoustical Analysis of Normal and Bimodal Bjork-Shiley 60-degree Convexo-Concave Heart Valves”, Am J Cardiol, vol 66, 1990.
  • Chwirut DJ and Regnault WF: “Fracture Mechanics Principles Applied to Implant Medical Devices – A Review”, Medical Progress Through Technology, vol 14, 1988.
  • Richard E. Galgon, “Understanding Medical Device Regulation”, Current Opinion in Anesthesiology, Vol 29, No. 6, Dec 2016
  • Robert A. Byrne, Patrick W. Serruys, Andreas Baumbach, Javier Escaned, Jean Fajadet, Stefan James, Michael Joner, Semih Oktay, Peter Juni, Adnan Kastrati, George Sianos, Giulio G. Stefanini, William Wijns, and Stephan Windecker, “Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary”, European Heart Journal (2015) 36, 2608-2620