Gerald L. Klein, MD

Principal
MedSurgPI, LLC.
Raleigh, NC, USA

Biography

EDUCATION

• (1965-1969), BS, University of Florida, Gainesville, FL, USA
• (1969-1975), MD, University of Brussels Medical School Brussels, Belgium

Research Interest

His research interests include: Clinical trials, Drug and device development, Medical monitoring, Safety and pharmacovigilance, GCPs, Medical writing

Scientific Activities

HONORS

• (1979), Accepted for presentation of the 1979 National Student Research Forum: Theophylline
Induced Suppression of T Cells Bearing IgM
• (1985-86), American Association for Clinical Immunology and Allergy, Chairman, Public Relations
Committee
• (1986), Joint Council of Allergy Education Committee Member
• (1986), American Association for Clinical Immunology and Allergy, Representative Speaker on
Lifetime Cable TV
• (1986), American Board of Allergy & Clinical Immunology Board Member Nominee
• (1987), American Board of Allergy & Immunology Review Course, Appointed to Faculty
• (1990-1993), American College of Allergy Asthma and Clinical Immunology, Board of Regents
• (1990), American College of Allergy & Clinical Immunology Alternate Delegate, House of Delegates
• (1991-1993), President, San Diego County Allergy Society
• (1991-1993), American College of Allergy & Clinical Immunology, Delegate, House of Delegates
• (1993-1994), American College of Allergy & Clinical Immunology
• (1994-1995), Executive Committee, Board of Regents
• (1994-1995), American Academy of Allergy and Immunology
• (1995-1996), Volunteer Faculty Member of the Year Nominee, University of California, Irvine
• (2010), Principal Investigator of $2,000,000 Naval grant for nonclinical studies of Oxycyte

Publications

1. Galant SP, Loscialpo AE, Klein GL, Glickman LT. The serological diagnosis of visceral larva migrans. Southern J. Med. 1979.
2. Klein GL, Galant SP. A comparison of the antipruritic efficacy of hydroxyzine and cyproheptadine in children with atopic dermatitis. Ann. Allergy. 1981.
3. Klein GL, Zenk V. A medication allergy profile (MAP) card. Ann. Allergy. 1981; 46(6): 328-330.
4. Ziering RW, Klein GL. Allergic disease: how to recognize and manager three common types. Journal Postgraduate Medicine. 1982; 72: 163-174.
5. Klein GL, Ziering RW. Improving the pharmacological treatment of the young child with asthma and allergies. Immunol. Practical Allergy. 1983.
6. Klein GL, Ziering RW. Diagnosing and treating the young child with asthma and allergy. Comprehensive Therapy. 1984.
7. Klein GL, Ziering RW, Miller MF: A simplified food challenge for allergic rhinitis and atopic dermatitis. Immunol. Allergy Pract. 1983.
8. Klein GL, Zeiring RW. Obstructive sleep apnea presenting as mouth breathing in a five year old. Immunol. Allergy Pract. 1984; 6: 9.
9. Klein GL, Zeiring RW, Girsh LS, Miller MF. The allergic irritability syndrome: Four case reports and a position statement, the neuroallergy committee of the american college of allergy. Ann Allergy. 1985; 55 (1): 22-24.
10. Klein GL, Zeiring RW. Once-a-day sustained-release theophylline: A clinical experience. J. Asthma. 1986; 23(2): 45-47. doi: 10.3109/02770908609077474
11. Klein GL, Zeiring RW, Miller MF, Novey H. Comparison of dipstick for specific IgE vs. skin test. Ann. Allergy. 1986; 23(2): 45-47.
12. Klein GL. Problems with generic theophylline and unknown brand switching. Ann. Allergy. 1987; 58: 350.
13. Klein GL. Treatment of allergic rhinitis in the elderly. Geriatrics. 1987.
14. Klein GL, Ziering RW, Miller MF. Comparison of a beaded capsule vs. liquid and tablet in treating childhood allergic rhinitis. Allergy Immunol. Pract. 1987.
15. Klein GL, Harrison LI. Effect of food on theophylline absorption from sustained-release products: Theolair-sr and theo-dur. Allergy Immunol. Pract. 1987.
16. Klein GL. Persistent allergic rhinitis in older patients: therapies worth trying. Geriatrics. 1987; 42(10): 91-94.
17. Klein GL: Theophylline dosing. Am J Asthma Allergy Pediatricians. 1988.
18. Klein GL. Non-sedating antihistamines. Amer. J. Asthma Allergy Pediatricians. 1988.
19. Kemp J, Klein GL, et al. The use of inhaled medication in school by students with asthma. JACI. 1989; 84(3): 400.
20. Klein GL. Keeping track: When others see your patients. Senior Patient. 1989.
21. Klein GL. Problems with the use of inhaled medication in the school system. Amer. J. Asthma Allergy Pediatricians. 1989; 2.
22. Klein GL, Ziering RW. The pinwheel: A diagnostic tool to detect wheezing in young children. Ped Asthma, Allergy & Immunol. 1990; 3: 1.
23. Klein GL. New aspects of inhaled medications. Amer. J. Asthma Allergy Pediatrics. 1990; 3(2).
24. Imam AA, Novey HS, Orgel HA, Klein GL, Meltzer EO, Ziering RW. A simplified screening test for the diagnosis of allergy. West J. Med. 1990; 152(3): 313-316.
25. Bronsky E, Goldberg S, Hawtylko E, Kaiser H, Klein GL, Leonard J. Urticaria: Clinical efficacy of cetirizine in comparison with hydroxyzine and placebo. J. Allergy Clin. Immunol.. 1990; 86: 1014-1018. doi: 10.1016/s0091-6749(05)80246-5
26. Klein GL. Treatment of sinusitis. Am. J. Asthma Allergy Pediatricians. 1991; 4(3):
27. Klein GL, Galant SP, Dungy C. Growth and nutrition in the non-steroid dependent asthmatic child. Ann. Allergy. 1991.
28. Klein GL. Medication update – new developments in environmental control. Amer. J. Asthma Allergy Pediatricians. 1991.
29. Klein GL. Controlling your allergies with environmental control. Postgrad. Med. 1992.
30. Ziering RW, Klein GL. Diagnosis and treatment of allergic rhinitis, management considerations. Postgrad. Med. 1992.
31. Klein GL, Ziering RW, Jaffe C. Pharmacologic and nonpharmacologic treatment of allergic rhinitis. J. Physician Assistants. 1993.
32. Klein GL, Ziering RW. Allergy tips of the month for physicians”, Immunol. Allergy Pract. 1983-1994.
33. Klein GL, Ziering RW. Allergy tips of the month for patients immunol. Allergy Pract. 1983-1994.
34. McDougle L, Klein GL, Hoehler FK. Management of hymenoptera sting anaphylaxis: A preventative medicine survey. J Emerg Med. 1995; 13(1): 9-13. doi: 10.1016/0736-4679(94)00105-7
35. Breneman D, Bronsky EA, Bruce S, et al. Cetirizine and astemizole therapy for chronic idiopathic urticaria: Double-blind, placebo-controlled comparative trial. J Amer Acad Derm. 1995; 33(2 Pt 1): 192-198. doi: 10.1016/0190-9622(95)90233-3
36. Spector SL, Klein GL, Bierman CW, et al. Comparative evaluation of zaditen vs. placebo in chronic idiopathic urticaria. 1996.
37. Klein GL. Non-prescription brompheniramine maleate versus terfenadine in treating symptomatic allergic rhinitis. 1996.
38. Klein GL, Whalen E, Echols RM, Heyd A. Ciprofloxacin versus cefuroxime axetil in the treatment of adult patients with acute bacterial sinusitis. J Otolaryngology. 1998; 27.
39. Klein GL. Acute rhinosinusitis: Treatment guidelines. Infections in Medicine. 1998.
40. Klein GL . Proceedings from a roundtable discussion: Update on the use of quinolones in acute rhinosinusitis. Trends in Drug Therapy. 1998.
41. Taskin D, Klein GL, Coleman S, et al. Comparing copd treatment: nebulizer, metered dose inhaler, and concomitant therapy. Am J Med. 2007; 120(5): 435-441. doi: 10.1016/j.amjmed.2006.07.043
42. Henry L, Dominique P, Klein GL. Petteway steve: Strengthening glp compliance. Quality Assurance Journal. 2006.
43. York J, Smeeding J, Brook RA, Hoehler F, Klein GL. An exploratory economic evaluation of chronic obstructive pulmonary disease (COPD) patients on combination product versus individual components (ipratropium bromide and albuterol). Adv Therapy. 2007; 24: 757-771. doi: 10.1007/BF02849969
44. Li H, Hawk S, Hanna K, Klein GL, Petteway S. Developing and implementing a comprehensive clinical qa audit program. Qual Assur J. 2007; 11: 128-137. doi: 10.1002/qaj.420
45. Li H, Vaughan L, Hanna K, Klein GL, Petteway S. Applying quality audit principles in managing quality of clinical documents. Quality Assurance Journal. 2009; 12: S40.
46. Li H, St. James D, Hanna K, Klein GL, Petteway S. Ensuring document quality throughout the life cycle of clinical trial-based publications. American Medical Writers Association Journal. 2009; 24(3): 115-116.
47. Brand P, Schulte MW, Herpich CH, Klein GL, Hanna K, Meyer T. Lung deposition of inhaled a1-proteinase inhibitor in cystic fibrosis and a1-antitrypsin deficiency. Eur Respir J. 2009; 34: 354-360. doi: 10.1183/09031936.00118408
48. Klein GL, Weaver EM, Bradshaw T. Medical foods: A distinct class of therapeutic agents. J Clin Trials. 2012; 2: 118. doi: 10.4172/2167-0870.1000118
49. Wilson D, Evans M, Weaver E, Shaw A, Klein GL. Evaluation of serum-derived bovine immunoglobulin protein isolatein subjects with diarrhea-predominant irritable bowel syndrome. Clin Med Insights Gastroenterol. 2013: 6: 49-60. doi: 10.4137/CGast.S13200
50. Klein GL, Weaver EM, Shaw A, and Petschow B. Gut barrier dysfunction and microbial translocation in cancer cachexia: a new therapeutic target. Curr Opin Support Palliat Care. 2013; 7(4): 361-367. doi: 10.1097/SPC.0000000000000017
51. Petschow B, Blikslager A, Weaver E, et al. Bovine immunoglobulin protein isolates for the nutritional management of enteropathy. World J Gastroenterol. 2014; 20(3): 11713-11726. doi: 10.3748/wjg.v20.i33.11713
52. Petschow B, Burnett B, Shaw A, Weaver E, Klein GL. Serum-derived bovine immunoglobulin/protein isolate: Postulated mechanism of action for management of enteropathy. Clin Exp Gastroenterol. 2014; 7: 181-190. doi: 10.2147/CEG.S62823
53. Bateman E, Weaver E, Klein GL, et al. Serum-derived bovine immunoglobulin/protein isolate in the alleviation of chemotherapy-induced mucositis. Support Care Cancer. 2015; 24(1): 377-385. doi: 10.1007/s00520-015-2806-6
54. Petshow BW, Burnett BP, Shaw AL, Weaver EM, Klein GL. Dietary requirement for serum derived bovine immunoglobulins in the clinical management of enteropathy. Dig Dis Sci. 2015; 60: 13-23. doi: 10.1007/s10620-014-3322-0
55. Shafran I, Burgunder P, Wei D, Young HE, Klein G. Management of inflammatory bowel disease with oral serum-derived bovine immunoglobulin. Therap Adv Gastroenterol. 2015; 8(6): 331-339. doi: 10.1177/1756283X15593693
56. Asmuth D, Somsouk M, Ma ZM, et al. Serum derived bovine immunoglobulin increases peripheral and mucosal CD4 Tcell count (MUC8P.736). J Immun. 2015; 194(1 Sup) 204.16. doi: 10.7448/IAS.18.5.20326
57. Shafran I, Youong H, Burgunder P, Klein GL. Pharmoeconomic benefit of bovine serum immunoglobulin in inflammatory bowel disease. Advance in Gastroenterology. 2016.
58. Shaw AL, Mathews DW, Hinkle JE, et al. Absorption and safety of serum-derived bovine immunoglobulin/protein isolate in healthy adults. Clin Exp Gastroenterol. 2016; 9: 365-375. doi: 10.2147/CEG.S120118
59. Klein G, Clarke M. The pharmacy adjudicated clinical study supply process decreases risk, cuts the cost and improves the efficiency when providing subjects unblinded clinical study supplies. Journal for Clinical Studies. 2017.
60. Klein GL. Double-blind, placebo controlled food challenge. J Allergy Clin Immunol. 1990; 85: 139. doi: 10.1016/0091-6749(90)90238-y