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Bert Spilker

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8004 Overhill Road
Bethesda, Maryland
20814-1145

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  • Bert Spilker & Associates
  • "Enhancing Your Meetings with FDA"
  • . Journal Articles by Bert L. Spilker

    Key to Journal Publications

    Number 
    1 Part of a Ph.D. thesis at Downstate Medical Center, Brooklyn, New York
    2-6 Work performed at the University of California Medical Center, San Francisco, California
    7-16 Work performed at Pfizer Ltd., Sandwich, Kent, England
    17-21 Work performed in collaboration with Dr. John Coltart at St. Bartholomews Hospital, London
    22-30 Work performed at Philips-Duphar, Weesp, The Netherlands
    31-41 Work performed at Sterling-Winthrop Research Institute, Rensselaer, New York
    42-43 Letters published while at Brown University Medical School, Providence, Rhode Island
    44 Work performed while at JRB Associates Inc., McLean, Virginia
    45 Work performed at the University of North Carolina Medical School, Chapel Hill, North Carolina
    46-105 Work performed at the Burroughs Wellcome Co., Research Triangle Park, North Carolina
    106-141 Work written while at Orphan Medical, Minnetonka, Minnesota
    142- Work written while at the Pharmaceutical Research and Manufacturers of America, Washington, D.C.


    A = Abstract; L = Letter

    PUBLICATIONS
    Number of
    Authors
    Order of
    Name on Paper

    1. Electrical membrane activity and frequency force relations in normal, denervated and reserpine- pretreated cat heart muscle. J. Pharmacol. Exp. Ther. 168: 60-69, 1969. With P. Cervoni.

    2

    1
    (A) 2. Augmenting and reducing phenomena: A cross correlation between VER and kinesthetic figural after effects. Communications in Behavioral Biology 1: 05681153, 1968. With E. Callaway.

    2

    1
    3. Visual evoked responses in subjects trained to control alpha rhythms. Psychophysiology 5 : 683-695, 1969. With J. Kamiya, E. Callaway, and C. Yeager.

    4

    1
    4. 'Augmenting' and 'Reducing' in averaged visual evoked responses to sine wave light. Psycho- physiology 6: 49-57, 1969. With E. Callaway.

    2

    1
    5. Ten year EEG studies in epileptic children (Two cases) Dis. Nerv. System 30: 194, 1969. With C. Yeager.

    2

    1
    6. Effects of drugs on 'augmenting/reducing' in averaged visual evoked responses in man. Psycho- pharmacologia (Berl.) 15: 116-124, 1969. With E. Callaway.

    2

    1
    7. Effects of dimethyl sulphoxide, dimethyl formamide and dimethyl acetamide on myocardial contractility and enzyme activity. Life Sciences 8: Part I: 1325- 1335, 1969. With R. A. Burges and K. J. Blackburn.

    3

    3
    (A) 8. The action of beta receptor antagonists on intracellular cardiac potentials. Br. J. Pharmacol. 38 : 448P, 1970. With S. Shevde.

    2

    2
    (A) 9. A characterization of the inotropic response to glucagon. Fed. Proc. 29: No. 2:611 (Abst. 2047), 1970.

    1

    1
    10. Spontaneous sympathetic activity in experimental heart failure. Experientia 26 : 512-514, 1970. With M. L. Hayden.

    2

    1
    11. Inotropic actions of dipolar aprotic solvents. J. Pharmacol. Exp. Ther. 175 : 361-367, 1970.

    1

    1
    12. Response to ouabain in acutely and chronically failed canine heart-lung preparations. Eur. J. Pharmacol. 11: 269-277, 1970. With M. L. Hayden.

    2

    1
    13. Comparison of the inotropic response to glucagon, ouabain and noradrenaline. Br. J. Pharmacol. 40: 382-395, 1970.

    1

    1
    14. Inotropic effects of thyroxine and related compounds on guinea pig left atria in vitro. Br. J. Pharmacol. 40: 526-527, 1970. With J. R. C. Baird.

    2

    2
    15. Alteration of Na+, K+ - dependent ATPase activity and inotropism by polyethylene glycol 300 in guinea pig atria. Biochem. Pharmacol. 20: 15-824, 1971. With D. R. Gadsdon and D. A. Rutty.

    3

    1
    16. Effect of various drugs on electrical and mechanical parameters of atrial muscle. Eur. J. Pharmacol. 15: 145-150, 1971. With S. Shevde.

    2

    1
    17. An electrophysiological study of human foetal cardiac muscle. Experientia 27: 797-799, 1971. With D. J. Coltart and S. J. Meldrum.

    3

    2
    (A) 18. Development of autonomic neural responses in human heart. Br. Heart J. 33: 612, 1971. With D. J. Coltart and S. J. Meldrum.

    3

    2
    (A) 19. Study of the contractile and electrophysiological maturation responses of the human foetal myocardium. Br. J. Pharmacol. 42: 653P-654P, 1971. With D. J. Coltart, S. J. Meldrum and R. B. Royds.

    4

    3
    20. Development of human foetal inotropic responses to catecholamines. Experientia 28: 525-527, 1972. With D. J. Coltart.

    2

    2
    (A) 21. An electrophysiological study of human foetal myocardium. Circulation 46: Suppl. II Abst. 107, 1972. With D. J. Coltart and S. J. Meldrum.

    3

    2
    (A) 22. On L-dopa induced hypotension in cats. Abst. 1319, Fifth International Congress on Pharmacology, 1972. With K. M. Dhasmana.

    2

    1
    (A) 23. Amantadine-induced differentiation between effects of nicotine and DMPP. Abst. 13th Dutch Federation Meetings, 318, 1972. With K. M. Dhasmana, J. E. Davies and V. Claassen.

    4

    1
    24. Pharmacological studies on dimethylsulphoxide. Arch. Int. Pharmacodyn. 200: 153-167, 1972.

    1

    1
    25. Peripheral cardiovascular effects in the pithed rat of compounds used in the treatment of hypertension. Br. J. Pharmacol. 46: 508-510, 1972. With K. M. Dhasmana and W. A. B. Fokker.

    3

    3
    26. On the mechanism of L-dopa induced postural hypotension in the cat. Br. J. Pharmacol. 47: 437-451, 1973. With K. M. Dhasmana.

    2

    2
    27. A comparative description of inotropic agents in vitro. Arch. Int. Pharmacodyn. 202: 325-341, 1973.

    1

    1
    28. Differentiation between effects of nicotine and DMPP by amantadine. Arch. Int. Pharmacodyn. 203: 221-231, 1973. With K. M. Dhasmana, J. E. Davies and V. Claassen.

    4

    1
    29. Formation and embolization of thrombi after electrical stimulation: On the method and evaluation of drugs. Thrombosis et Diasth. haemorrh. 30: 352-362, 1973. H. von Balken.

    2

    1
    30. On the specificity of dopamine release by amantadine. Experientia 30: 64-65, 1974. With K. M. Dhasmana.

    2

    1
    (A) 31. Lack of cardiac or bronchiolar tolerance to isoproterenol in the anesthetized dog. The Pharmacologist 15: 217, 1973. With H. Minatoya.

    2

    2
    (L) 32. Increase in asthma mortality. Br. Med. J. 4: 171-172, 1973.

    1

    1
    33. Guinea pig atrial and pulmonary beta-adrenoceptors. Arch.Int. Pharmacodyn. 207: 220-230, 1974. With W. B. McKeon, Jr. and A. Arnold.

    3

    1
    34. Lack of cardiac or bronchodilator tachyphlaxis to isoprenaline in the dog. Br. J. Pharmacol. 53: 333-340, 1975. With H. Minatoya.

    2

    2
    (A) 35. Comparison of animal models for predicting broncho- dilator efficacy in man. The Pharmacologist 16: 211, 1974. With H. Minatoya and W. B. McKeon, Jr.

    3

    1
    36. Cardiovascular effects and blood concentrations of ajmaline and its 17-monochloroacetate ester in cats. Arch. Int. Pharmacodyn. 216: 63-78, 1975. With L. Shargel, R. F. Koss and H. Minatoya.

    4

    1
    37. Comparison of animal models for predicting broncho- dilator efficacy in man. Arch. Int. Pharmacodyn. 217: 218-235, 1975. With H. Minatoya and W. B. McKeon, Jr.

    3

    1
    38. The role of bronchoconstrictors in evaluating smoothe muscle relaxant activity. Arch. Int. Pharmacodyn. 217: 201-217, 1975. With H. Minatoya.

    2

    1
    (A) 39. Anti-asthmatic studies on chloroquine in animals. The Pharmacologist 17: 191, 1975. With five co-authors.

    6

    1
    40. On the question of tachyphylaxis to isoproterenol in guinea pigs. Eur. J. Pharmacol. 36: 283-288, 1976. With J. Tyll.

    2

    1
    41. Anticholinergic activity of antipsychotic drugs in relation to their extrapyramidal effects. J. Pharm. Pharmac. 28: 302-304, 1976. With J. Pearl, W. A. Woodward and R. G. Bentley.

    4

    2
    (L) 42. Medication records. J.A.M.A. 239: 929, 1978.

    1

    1
    (L) 43. On increasing autopsy rates. New England J. Med., 298: 634, 1978.

    1

    1
    44. How useful is hair analysis? J. of Energy Medicine 1: 15-19, 1980. With T.H. Maugh II.

    2

    1
    45. Drug interference with measurement of metanephrines in urine. Annals Clin. Lab. Sci. 13: 16-19, 1983. With B.S. Watson and J.W. Woods.

    3

    1
    (A) 46. A novel double-blind method to evaluate topically applied skin creams. Clin. Pharmacol. Ther. 33: 215, 1983. With C.J. Tullio, S.H. Poe, J. G. Perkins.

    4

    1
    (A) 47. Controlled trial of cinromide in epileptics with partial seizures. Epilepsia 24: 254-255, 1983. With nine coauthors.

    10

    1
    48. A double-blind crossover study of cinromide versus placebo in epileptic outpatients with partial seizures. Epilepsia 24: 410-421, 1983. With five coauthors.

    6

    1
    49. A multicenter study of the efficacy and safety of cinromide in patients with partial seizures. Curr. Ther. Res. 34: 7-14, 1983. With eleven coauthors.

    12

    1
    (A)50. Practical considerations in planning and conducting human drug trials. Second World Conference on Clinical Pharmacology and Therapeutics, Washington, D.C. July 31-August 5, 1983. Abst. 734, page 126.

    1

    1
    (A)51. A proposed strategy for the clinical assessment of anti-epileptic drugs. Second World Conference on Clinical Pharmacology and Therapeutics, Washington, D.C. July 31-August 5, 1983. Abst. 737, page 127. With five coauthors.

    6

    2
    52. Practical considerations in planning and conducting clinical trials with investigational or marketed drugs. Clin. Neuropharmacology 6: 325-347, 1983.

    1

    1
    (A)53. Methods for the assessments of drugs in partial epilepsy. International Epilepsy Meetings, Washington, D.C., September, 1983. With three co-authors.

    4

    2
    54. A novel double-blind method to evaluate topically applied antihistamine creams. Curr. Ther. Res. 35: 584-592, 1984. With C. Tullio and J. G. Perkins.

    3

    1
    55. A novel double-blind method to evaluate topically applied antipruritic drugs. Curr. Ther. Res. 35: 593-605, 1984. With R. D. Wilkins and J. G. Perkins.

    3

    1
    56. Validation of the phenomenon of regression of seizure frequency in epilepsy. Epilepsia 25: 443-449, 1984. With A. Segreti.

    2

    1
    (A)57. Examination of the phenomenon of regression of seizure frequency towards the median in epilepsy. Epilepsia 25: 658, 1984. With A. Segreti.

    2

    1
    58. Myths and misconceptions about drug industry ethics. Internat. J. of Applied Philosophy 2: 1-11, 1984.

    1

    1
    59. Development of orphan drugs. Trends Pharmacol. Sci. 6: 185-188, 1985.

    1

    1
    60. On the increasing importance of single-patient double-blind studies. Drug News & Perspectives 1: 160-163, 1988.

    1

    1
    61. Golden rules of clinical drug development. Drug News & Perspectives 1: 222-225, 1988.

    1

    1
    62. Choosing formats for presenting clinical data. Drug News & Perspectives 1: 282-283, 1988.

    1

    1
    63. Changing images of the American drug industry. Drug News & Perspectives 1: 325-328, 1988. With P. Cuatrecasas.

    2

    1
    64. Golden rules of drug discovery. Drug News & Perspectives 2: 26-30, 1989.

    1

    1
    65. Assessing risks. Drug News & Perspectives 2: 69-73, 1989. With P. Cuatrecasas.

    2

    1
    66. Models of how clinical research is conducted. Drug News & Perspectives 2: 161-163, 1989.

    1

    1
    67. Elements of a clinical strategy and development plan. Drug News & Perspectives 2: 222-228, 1989.

    1

    1
    68. Missions, objectives, goals, strategies, and tactics revisited. Drug News & Perspectives 2: 281-286, 1989.

    1

    1
    69. Goals and future directions of clinical trials. Drug News & Perspectives 2: 337-341, 1989.

    1

    1
    70. Career opportunities in fields related to drugs. Drug News & Perspectives 2: 389-396, 1989.

    1

    1
    71. Career opportunities for physicians in the pharmaceutical industry. J. Clin. Pharmacol. 29: 1069-1076, 1989. Ten thousand copies distributed via PMA.

    1

    1
    72. Meta-Analysis. Drug News & Perspectives 2: 464-469, 1989.

    1

    1
    73. Patient refusers, nonqualifiers, dropouts, dropins and discontinuers. Drug News & Perspectives 3: 14-18, 1990.

    1

    1
    74. Remote data entry. Drug News & Perspectives 3: 95-98, 1990.

    1

    1
    75. Roles of medical contractors in drug development. Drug News & Perspectives 3: 148-152, 1990.

    1

    1
    76. Prospective registration of clinical trials. Drug News & Perspectives 3: 222-225, 1990.

    1

    1
    77. Auditing a clinical trial. Drug News & Perspectives 3: 280-286, 1990.

    1

    1
    78. Marketing studies. Drug News & Perspectives: 3: 369-371, 1990.

    1

    1
    79. Data review committees. Drug News & Perspectives 3: 417-420, 1990.

    1

    1
    80. National versus multinational clinical trials. Drug News & Perspectives 3: 469-474, 1990.

    1

    1
    81. Archiving clinical trial data. Drug News & Perspectives 3: 527-528, 1990.

    1

    1
    82. Training professionals in clinical trial methods. Drug News & Perspectives 3: 606-613, 1990.

    1

    1
    83. Guest editorial. Medical Care 28 (12- Suppl.): DSI, 1990. With H. Tilson.

    2

    2
    84. Institutional memory in the pharmaceutical industry. Drug News & Perspectives 4: 25-27, 1991.

    1

    1
    85. Models of international operations and styles. Drug News & Perspectives 4: 142-149, 1991.

    1

    1
    86. Extrapolation of preclinical safety data to humans. Drug News & Perspectives 4: 211-216, 1991.

    1

    1
    87. Dose-response relationships in clinical trials. Drug News & Perspectives 4: 295-303, 1991.

    1

    1
    88. Are there golden rules for staffing? Drug News & Perspectives 4: 358-361, 1991.

    1

    1
    89. Planning for medicine discovery in the distant future. Drug News & Perspectives 4: 389-393, 1991.

    1

    1
    90. Criteria and standards for evaluating medicine discovery and development. Drug News & Perspectives 4: 453-458, 1991.

    1

    1
    91. Transferring medicine discoveries from academia to industry. Drug News & Perspectives 4: 597-600,1991.

    1

    1
    92. Licensing activities in the pharmaceutical industry. Drug News & Perspectives 5: 6-19, 1992.

    1

    1
    93. Pharmacopolitics: A new discipline for an old subject. Drug News & Perspectives 5: 69-77, 1992.

    1

    1
    94. Industry interaction with legislators and the public. Pharmaceutical Executive 12 (5): 58-66, 1992.

    1

    1
    95. Defining the pharmaceutical industry. Drug News & Perspectives 5: 139-144, 1992.

    1

    1
    96. Enhancing communication. Drug News & Perspectives 5: 236-246, 1992.

    1

    1
    97. Methods of assessing and improving patient compliance in clinical trials. IRB: A Review of Human Subjects Research 14 (3): 1-5, 1992.

    1

    1
    98. New software technology for visualizing clinical trial data. Drug News & Perspectives 5: 298-305, 1992.

    5

    1
    99. Standardization of quality of life trials: An industry perspective. PharmacoEconomics 1: 73-75, 1992.

    1

    1
    100. Strategies for dealing with patent expiration. Drug News and Perspectives 5: 370-374, 1992.

    1

    1
    101. Crises management. Drug News & Perspectives 5: 422-426, 1992.

    1

    1
    102. Switching prescription medicines to over-the- counter status. Drug News & Perspectives 5: 494-500, 1992.

    1

    1
    103. Conflicts of interest in pharmaceutical companies. Drug News & Perspectives 5: 561-571, 1992.

    1

    1
    104. Types of standards used in medicine development. Drug News & Perspectives 5: 595-603, 1992.

    1

    1
    105. Patient package inserts and disease oriented brochures. Drug News & Perspectives 6: 42-48, 1992.

    1

    1
    106. Providing product information to health professionals. Drug News & Perspectives 6: 114-122, 1993.

    1

    1
    107. Mergers, joint ventures and alliances. Drug News & Perspectives 6: 169-176, 1993.

    1

    1
    108. Clinical trials come of age. Drug News & Perspectives 6: 224-228, 1993.

    1

    1
    109. Worldwide compatibility of diagnostic criteria. Drug News & Perspectives 6: 406-413, 1993.

    1

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    110. Qualifications necessary to interpret clinical data. Drug News & Perspectives 6: 604-607, 1993.

    1

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    111. Incorporating benefit to risk determinations in medicine development. Drug News & Perspectives 7: 53-59, 1994.

    1

    1
    112. Telescoping the medicine development process. Drug News & Perspectives 7: 119-123, 1994.

    1

    1
    113. Mastering alternative distribution channels. Pharmaceutical Executive 14: 46-56, 1994. With D. Burton.

    2

    1
    114. Normalcy, supernormalcy, and subnormalcy. Drug News & Perspectives 7: 289-294, 1994.

    1

    1
    115. Use and abuse of pharmacoeconomic trials. Drug News & Perspectives 7: 363-369, 1994.

    1

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    116. Collecting and interpreting life events data in clinical trials. Applied Clinical Trials 3: 45-52, 1994.

    1

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    117. Overview of medicine development. Drug News & Perspectives 8: 146-150, 1995.

    1

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    118. Proposals sent by academicians to pharmaceutical companies. Drug News & Perspectives 8: 226-229, 1995.

    1

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    119. Orphan drug challenge for pharmaceutical companies. Drug News & Perspectives 9: 399-404, 1996.

    1

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    120. Orphan drug act of 1983. Drug News & Perspectives 9: 460-462, 1996.

    1

    1
    121. Virtual drug development on a global basis. Drug News & Perspectives 9: 524-531, 1996.

    1

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    122. Phases of clinical trials and phases of drug development. Drug News & Perspectives 9: 601-606, 1996.

    1

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    123. Evaluating advice and information on drug development. Drug News & Perspectives 10: 89-92, 1997.

    1

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    124. Managing in an environment of uncertainty. Drug News & Perspectives 10: 152-155, 1997.

    1

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    125. The seven(teen) deadly sins in pharmaceutical companies. 10: 203-207, 1997.

    1

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    (A)126. Uses and misuses of quality of life data. Epilepsia 38: Suppl. 3, 162, 1997.

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    127. Asking the right pharmaceutical question (and getting the right answer). Drug News & Perspectives 10: 261-266, 1997.

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    128. Formulating and using pharmaceutical metaphors. Drug News & Perspectives 10: 389-393, 1997.

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    129. Developing and using pharmaceutical frames of reference. Drug News & Perspectives 10: 453-455, 1997.

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    130. Pharmaceutical benchmarks. Drug News & Perspectives 10: 517-521, 1997.

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    131. Comparing pharma think with academic and government think Drug News & Perspectives 10:581-586, 1997.

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    132. The importance of pharma sense and pharma think. Drug News & Perspectives 11:5-9, 1998.

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    133. Differentiating between current fashions and major innovations. Drug News & Perspectives 11:69-72, 1998.

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    134. Pharmaceutical tangents: the good, the bad and the ugly. Drug News & Perspectives 11:133-138, 1998.

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    135. Creating standards for basic, medical and market research. Drug News and Perspectives 11:197-203, 1998.

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    136. Applying pharmaceutical lessons: learning lessons from. the past Drug News & Perspectives 12: 261-264, 1999.

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    137. Reducing pharmaceutical risk. Drug News & Perspectives 12: 325-330, 1999.

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    138. Using teams and committees. Drug News & Perspectives 12: 389-393, 1999.

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    139. The many faces of reality. Drug News & Perspectives 12: 453-457, 1999.

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    140. Developing a pharmaceutical perspective. Drug News & Perspectives 12: 517-522, 1999.

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    141. Quality and quality of data. Drug News & Perspectives 12: 605-610, 1999.

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    142. U.S. drug and biologic approvals in 1998. Drug Development Research 48: 139- 153, 1999. With S. Fitz Simmons and M. Horan.

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    143. Industry faces the drug safety issue. MM&M: 150-157, July, 2000. With S. FitzSimmons and A. Goldhammer.

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