Publications

Allergy/Immunology

Miao S, Suso P, Furst JA, Hudson MG, Trivedi A. Effect of Mild or Moderate Hepatic Impairment on the Pharmacokinetics of Avacopan, a Small-Molecule Complement C5a Receptor Antagonist, for the Treatment of Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis. Clin Pharmacol Drug Dev. Published online July 11, 2024. doi:10.1002/cpdd.1444

Feiss G., Morris R., Rom D. et al. (1992). A comparative study of the effects of intranasal triamcinolone acetonide (ITAA) and prednisone on adrenocortical function. The Journal of Allergy and Clinical Immunology, 89(6), 1151-1156.

Howland WC, Dockhorn R, Gillman S, Gross GN, Hille D, Simpson B, Furst JA, Feiss G, Smith JA. A comparision of effects of triamcinolone acetonide aqueous nasal spray, oral prednisone, and placebo on adrenocortical function in male patients with allergic rhinitis. J of Allergy Asthma Immunol. 1996; July: 98(1): 32-38.

Munk ZM, LaForce C, Furst JA, Simpson B, Feiss G, Smith JA. Efficacy and safety of triamcinolone acetonide aqueous nasal spray in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 1996; Oct: 77(4): 277-81- Study RG 5029Y-301.

Banov CH, Silvers WS, Green AW, van Bavel JH, Winder JA, Feiss G, Simpson B, Furst JA, Smith JA. Placebo-controlled, double-blind study of the efficacy of triamcinolone acetone aerosol nasal inhaler in pediatric patients with seasonal allergic rhinitis. Clin Ther. 1996 Mar-Apr; 18(2):265-72.- Study RG 5029-121.

Storms WW, Southern DL, Feiss, G, Simpson B, Furst JA, Smith JA. Efficacy of triamcinolone acetonide aerosol nasal inhaler in children with perennial allergic rhinitis. Pediatric Asthma, Allergy & Immunology (submitted 3/96). – Study 5029-120.

Gross, G, Boggs, P, Ginchansky E, Howland W, Munk Z, Weakley S, Alderfer V, Simpson B, Feiss, G, Furst JA, Smith JA. A placebo-controlled double-blind comparison of topical versus systemic triamcinolone aqueous nasal spray in seasonal allergic rhinitis. AM J of Rhinology (submitted 12/95). – Study RG 5029Y-308.

Smith JA, Beaucher WN, Kobayashi RH, Koepke JW, Ransom JH, Rosen JP, Feiss G, Furst JA, Simpson B. Long-term safety and efficacy of triamcinolone acetonide aqueous nasal spray for the treatment of perennial allergic rhinitis. Allergy Asthma Proc 1997 Jan-Feb; 18(1):33-7 Study RG 5029Y-305LT.

Smith JA, Schenkel E, Gross G, Jacobson K, Kobayashi R, Settipane G, Feiss G, Furst J, Simpson B. Efficacy and safety of once-daily triamcinolone acetonide aqueous nasal spray in pediatric patients with spring grass seasonal allergic rhinitis. J of Allergy and Clinical Immunology 1996; 97:197 (No. 1 Pt. 3). Abstracts. – RG 5029Y-312.

LaForce K, Hampel F, Kiechel F, Lumry W, Murray J, Furst JA, Simpson B, Smith JA. Comparison of once-daily triamcinolone acetonide aqueous nasal spray and twice –daily Beconase AQ® for the treatment of seasonal allergic rhinitis due to ragweed. J of Allergy and Clinical Immunology. 1996; 97:433 (No. 1, Pt. 3). Abstract. – Study RG 5029Y-406.

Cardiology

Antman E, McCabe C, Gurfinkel E, Turpie G, Bernink P, Salien D, Bayes De Luna A, Fox K, LaBlanche JM, Radley D, Furst JA, Braunwald E. Treatment Benefit of Enoxaparin in Ustable Angina/Non-Q-Wave Myocardial Infarction is Maintained at One Year Follow-up in TIMI 11B. Abstract accepted for oral presentation at the 72nd annual Scientific Session of the American Heart Association, Atlanta USA, Nov 1999.

Cohen M, Antman E, Gurfinkel E, Turpie A, Furst JA, Bigonzi F Radley R. Impact of enoxaparin low molecular weight heparin in patients with Q-wave myocardial infarction. Am J Cardiol 2000 Sept 1;86(5):553-6, A9.

Kopecky SL, Aviles RJ, Bell MR, Lobl JK, Tipping D, Frommell G, Ramsey K, Holland AE, Midei M, Jain A, Kellet M, Gibbons RJ. A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study Measuring the Effect of an Adenosine Agonist on Infarct Size Reduction in Patients Undergoing Primary Percutaneous Transluminal Coronary Angioplasty (the ADMIRE [AMP579 Delivery for Myocardial Infarction Reduction] Study), Am Heart J 2003 146:146-52

Dermatology

U. Mrowietz, T. H. Kedem, R. Keynan, M. Eini, D. Tamarkin, D. M. Rom, M. H. Shirvan. A Phase II, Randomized, Double-Blind Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Topical Minocycline Foam, FMX103, for the Treatment of Facial Papulopustular Rosacea (2018). American Journal of Clinical Dermatology.

Baker, D., Ferris, D., Martens, M., Fife, K., Tyring, S., Edwards, L., Nelson, A., Ault, K., Trofatter, K., Liu, T., Levy, S., & Wu, J. (2011). Imiquimod 3.75% Cream Applied Daily to Treat Anogenital Warts: Combined Results from Women in Two Randomized, Placebo-Controlled Studies. Infectious Diseases in Obstetrics and Gynecology, 2011.

Hanke, C.W., Swanson, N., Bruce, S., Berman, B., Kulp, J., Levy, S. (2011). Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face and balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. J Drugs Dermatol, 10(2), 165-170.

Buchner, L., Vamvakias, G., Rom, D. (2010). Validation of a photonumeric wrinkle assessment scale for assessing nasolabial fold wrinkles. Plastic and Reconstructive Surgery, 126(2), 596-601.

Jorizzo, J., Markowitz, O., Lebwohl, M., Bourcier, M., Kulp, J., Meng, T., Levy, S. (2010). A randomized, double-blind, placebo-controlled, multicenter, efficacy and safety study of 3.75% imiquimod cream following cryosurgery for the treatment of actinic keratoses. J Drugs Dermatol, 9(9), 1101-1108.

Kulp, J., Levy, S., Fein, M.C., Adams, M., Furst, J., Meng, T. (2010). Pharmacokinetics of imiquimod 3.75% cream applied daily for 3 weeks to actinic keratoses on the face and/or balding scalp. Arch Dermatol Res., 302, 539-544.

Del Rosso, J.Q., Sofen, H., Leshin, B., Meng, T.C., Kulp, J., Levy, S. (2009). Safety and Efficacy of Multiple 16-week Courses of Topical Imiquimod for the Treatment of Large Areas of Skin Involved with Actinic Keratoses. Clin Aesthetic Dermatol, 2(4), 20-28.
Young, A.L., Levy, S., Nighland, M., Grossman, R., Silvers, S.N., Celebi, J.T. (2009). Are dark-skinned people really protected from ultraviolet radiation? Clin Exp Dermatol.

Eichenfield L.F, Nighland, M., Rossi, A.B., Cook-Bolden, F., Grimes, P., Fried, R., Levy, S. (2008). Phase 4 study to assess tretinoin pump for the treatment of facial acne. J Drugs in Dermatology, 7(12), 112.

Levy, S. et al. (2001). The efficacy of metronidazole 1% cream once daily compared with metronidazole 1% cream twice daily and their vehicles in rosacea: A double- blind clinical trial. American Journal of Clinical Dermatology, 2(1), 33-39.

Kulp J, Levy S, Fein MC, Adams M, Furst J, Meng TC. Pharmacokinetics of imiquimod 3.75% cream applied daily for 3 weeks to actinic keratosis on the face and/or balding scalp. Arch Dermatol Res. 2010 Sep;302(7):539-44. Epub 2010 Mar 4.

Statistics

Sanat Sarkar, Dror Rom & Jaclyn McTague (2021): Incorporating the sample correlation into the testing of two endpoints in clinical trials, Journal of Biopharmaceutical Statistics, DOI: 10.1080/10543406.2021.1895191 

Ganju, J. and Rom, D. (2017). Non-inferiority versus superiority drug claims: the (not so) subtle distinction. Trials. 2017 Jun 15;18(1):278. doi: 10.1186/s13063-017-2024-2

Gou, J., Tamhane, C. A., Xi, D., and Rom, D. M.A (2014). class of improved hybrid Hochberg–Hommel type step-up multiple. Biometrika, Volume 101, Issue 4, 1 December 2014, Pages 899–911,

Rom, D. M. (2012). An improved Hochberg procedure for multiple tests of significance British J Math Stat Psychol. 2013 Feb;66(1):189-96

Westfall, P.H., Tobias, R. D., Rom, D. M., Wolfinger, R. D., Hochberg, Y. (1999). Multiple Comparisons and Multiple Tests. SAS Publication

Rom, D. M. and Hwang, E. (1996). Testing for bioequivalence of treatment effects based on the proportion of similar responses. Statistics in Medicine, 15, 1489-1505.

Hochberg Y. and Rom D. M. (1995). Extensions of Simes’ test for logically related hypotheses. Journal of Statistical Planning and Inference, 48, 141-152.

Rom, D. M. and Holland, B. (1995). A new closed multiple testing procedure for hierarchical family of hypotheses. Journal of Statistical Planning and Inference, 46, 265-275.

Chang, C. K., and Rom, D. M. (1994). On the analysis of multiple correlated binary endpoints in medical studies. Proceedings of the Interface between Computing Science and Statistics.

Rom, D. M. (1994). Multiple comparisons, selection and applications in biometry (book review). Biopharmaceutical Report, 2(2), 17.

Rom, D. M. and Connell, L. (1994). A generalized family of multiple test procedures. Communications in Statistics. Theory and Methods, 23(11), 3171-3187.

Rom, D. M., Costello, R. and Connell, L. (1994). On closed test procedures for dose response analysis. Statistics in Medicine, 13, 1583-1596.

Rom, D. M. (1992). Strengthening some common multiple test procedures for discrete data. Statistics in Medicine, 11, 511-514.

Rom, D. M. and Sarkar, S. K. (1992). A generalized model for the analysis of association in ordinal contingency tables. Journal of Statistical Planning and Inference, 33, 205-212.

Rom, D. M. (1990). A sequentially rejective test procedure based on a modified Bonferroni Inequality. Biometrika, 77, 663-665.

Rom, D. M. and Sarkar, S. K. (1990). Approximating probability integrals of multivariate normal using association models. Statistical Computation and Simulation, 35, 109-119.

Rom, D. M. and Sarkar, S. K. (1989). The probability integrals of the multivariate normal: the 2n tree and association models. Proceedings of the Interface between Computing Science and Statistics, 20, 426-431.

Heyse, J. F. and Rom, D. (1988). Adjusting for multiplicity of statistical tests in the analysis of carcinogenicity studies. Biometrical Journal, 30, 883-896.

Women's Health

Levine DW, Dailey ME, Rockhill B, Tipping D, Naughton MJ, Shumaker SA. Validation of the Women’s Health Initiative Insomnia Rating Scale in a Multicenter Controlled Clinical Trial, Psychosomatic Medicine 2005 67:98-104

Archer DF, Furst K, Tipping D, Dain MP, VandePol C. A Randomized Comparison of Continuous Combined Transdermal Delivery of Estradiol-Norethindrone Acetate Versus Estradiol Alone for Menopause Treatment, Obstetrics and Gynecology 1999 94(4)498-503

Lee TY, Li J, Hudson M, Ferreira JCA, Migoya E (2021) Bioequivalence of a Fixed-Dose Combination Tablet, Relugolix/Estradiol (E2)/Norethindrone Acetate (NETA) (40 mg/1 mg/0.5 mg) and Co-Administration of Relugolix 40-mg and E2/NETA (1 mg/0.5 mg) Tablets. Abstract accepted for oral presentation at the Clinical Pharmacology - Chemical Session of the 2021 PharmSci 360, Phildelphia USA, Oct 2021.