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References

Lesson 5

Pharmacodynamics and Pharmacokinetics : References

The following page includes a quiz that will be used to assess your mastery of the lesson content. If you are completing the course for continuing education credit, you must successfully complete each lesson quiz. Go to Lesson 1 quiz.

  1. U.S. Department of Health and Human Services, Food and Drug Administration. (1993). Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs, Part IV. Retrieved January 19, 2006, from http://www.fda.gov/cder/guidance/old036fn.pdf.PDF Icon
  2. U.S. General Accounting Office. (2001). GAO-01-286R. Drugs withdrawn from market. Retrieved January 16, 2006, from http://www.gao.gov/new.items/d01286r.pdf.PDF Icon
  3. Huang, S. M, Miller, M., Toigo, T., Chen, M. C., Sahajwalla, C., Lesko, L. J., & Temple, R. (2004). Principles of gender-specific medicine. San Diego, CA: Elsevier Academic Press.
  4. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health. (1999). Agenda for research on women's health for the 21st century. A Report of the task force on the NIH women's health research agenda for the 21st century, volume 2. Bethesda, MD. NIH Publication No. 99-4386. Retrieved March 7, 2006, from http://orwh.od.nih.gov/research/Agenda_Book_2.pdf.PDF Icon
  5. Anthony, M., & Berg, M. J. (2002). Biologic and molecular mechanisms for sex differences in pharmacokinetics, pharmacodynamics, and pharmacogenetics: Part II. Journal of Women's Health and Gender-Based Medicine, 11, 617-629. PubMed
  6. Aarons, L., Hopkins, K., Rowland, M., Brossel, S., & Thiercelin, J. F. (1989). Route of administration and sex differences in the pharmacokinetics of aspirin, administered as its lysine salt. Pharmaceutical Research, 6, 660-666. PubMed
  7. Ibid., pp. 660-666.
  8. Knight, V., Yu, C. P., Gilbert, B. E., & Divine, G. W. (1988). Estimating the dosage of ribavirin aerosol according to age and other variables. Journal of Infectious Diseases, 158, 443-448. PubMed
  9. Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter? (T. M. Wizeman & M. L. Pardue, Eds.). Washington, DC: National Academy Press, p. 121.
  10. Ibid., p. 120.
  11. Cummins C.L., Wu C.Y., & Benet, L.Z. (2002). Sex-related differences in the clearance of cytochrome P450 3A4 substrates may be caused by P-glycoprotein. Clinical Pharmacology and Therapeutics, 72, 474-89; and Schuetz, E. G., Furuya, K. N., & Schuetz, J. D. (1995). Interindividual variation in expression of P-glycoprotein in normal human liver and secondary hepatic neoplasms. Journal of Pharmacology and Experimental Therapies, 275, 1011-1018. PubMed
  12. Wolbold, R., Klein, K., Burk, O., Nussler, A. K., Neuhaus, P., Eichelbaum, M., Schwab, M., & Zanger, U. M. (2003). Sex is a major determinant of CYP3A4 expression in human liver. Hepatology, 38, 978-988. PubMed
  13. Datz, F.L., Christian, P. E., & Moore, J. (1987). Gender-related differences in gastric emptying. Journal of Nuclear Medicine, 28, 1204-1207. PubMed
  14. Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter?, p. 121.
  15. Benet, L. Z., & Hoener, B. A. (2002). Changes in plasma protein binding have little clinical relevance. Clinical Pharmacology and Therapeutics, 71, 115-121.
  16. MacKichan J. J. (1992). Influence of protein binding and use of unbound (free) drug concentrations, pp. 1-48. In: Applied Pharmacokinetics, Principles of Therapeutic Drug Monitoring, revised 3rd ed. (W. E. Evans, J. J. Schentag, & W. Jusko, Eds.). Vancouver, British Columbia, Canada: Applied Therapeutics, Inc. Cited in: Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter? (T.M. Wizeman & M. L. Pardue, Eds.). Washington, DC: National Academy Press, p. 124.
  17. Plymate, S. R., Moore, D. E., Cheng, C. Y., Bardin, C. W., Southworth, M. B., & Levinski, M. J. (1985). Sex hormone-binding globulin changes during the menstrual cycle. Journal of Clinical Endocrinology and Metabolism, 61, 993-996. PubMed; Cited in: Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter? (T. M. Wizeman & M. L . Pardue, Eds.). Washington, DC: National Academy Press, p. 123.
  18. Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter?, p. 125.
  19. Ibid., p. 123.
  20. Paine, M. F., Ludington, S. S., Chen, M. L., Stewart, P. W., Huang, S. M., & Watkins, P. B. (2005). Do men and women differ in proximal small intestinal CYP3A or P-glycoprotein expression? Drug Metabolism and Disposition, 33, 426-433. PubMed
  21. Wolbold, R., Klein, K., Burk, O., Nussler, A. K., Neuhaus, P., Eichelbaum, M., Schwab, M., & Zanger, U. M. (2003). Sex is a major determinant of CYP3A4 expression in human liver. Hepatology, 38, 978-988. PubMed
  22. Ibid., pp. 978-988.
  23. Harris, R. Z., Benet, L. Z., & Schwartz, J. B. (1995). Gender effects in pharmacokinetics and pharmacodynamics. Drugs, 50, 222-239. PubMed; Cited in: Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter? (T. M. Wizeman & M. L. Pardue, Eds.). Washington, DC: National Academy Press, p. 125.
  24. Paine et al. Do men and women differ in proximal small intestinal CYP3A or P-glycoprotein expression? pp. 426-433.
  25. Jennings, T. S., Nafziger, A. N., Davidson, L., & Bertino, J. S., Jr. (1993). Gender differences in hepatic induction and inhibition of theophylline pharmacokinetics and metabolism. Journal of Laboratory and Clinical Medicine, 122, 208-216. PubMed
  26. Paaby, P., Moller-Petersen, J., Larsen, C. E., & Raffn, K. (1987). Endogenous overnight creatinine clearance, serum beta 2-microglobulin and serum water during the menstrual cycle. Acta Medica Scandinavica, 221, 191-197. PubMed; Cited in: Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter? (T. M. Wizeman & M. L. Pardue, Eds.). Washington, DC: National Academy Press, p. 126.
  27. Harris et al. Gender effects in pharmacokinetics and pharmacodynamics, pp. 222-239; Anderson, G.D. (2005). Sex and racial differences in pharmacological response: where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics. Journal of Women's Health, 14, 19-29 PubMed; Donovan, M. D. (2005). Sex and racial differences in pharmacological response: route of administration and drug delivery system on pharmacokinetics. Journal of Women's Health, 14, 30-37 PubMed; Meibohm, B., Beierle, I., & Derendorf, H. (2002). How important are gender differences in pharmacokinetics? Clinical Pharmacokinetics, 41, 329-342 PubMed; Schwartz, J.B. (2003). The influence of sex on pharmacokinetics. Clinical Pharmacokinetics, 42, 107-121. PubMed
  28. Harris et al. Gender effects in pharmacokinetics and pharmacodynamics, pp. 222-239.
  29. Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter?, p. 126.
  30. Harris et al. Gender effects in pharmacokinetics and pharmacodynamics, pp. 222-239.
  31. Nishizawa, S., Benkelfat, C., Young, S. N., Leyton, M., Mzengeza, S., De Montigny, C. et al. (1997). Differences between males and females in rates of serotonin synthesis in human brain. Proceedings of the National Academy of Sciences of the United States of America, 94, 5308-5313. PubMed Cited in: Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter? (T. M. Wizeman & M. L. Pardue, Eds.). Washington, DC: National Academy Press, p. 130.
  32. Henney, J.E. (2000). From the Food and Drug Administration. JAMA: the Journal of the American Medical Association, 283, 2779. Cited in: Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter? (T. M. Wizeman & M. L. Pardue, Eds.). Washington, DC: National Academy Press, p. 130.
  33. Frackiewicz, E. J., Sramek, J. J., & Cutler, N. R. (2000). Gender Differences in depression and pharmacokinetics and adverse events. Annals of Pharmacotherapy, 34, 80-88. PubMed
  34. Harris et al. Gender effects in pharmacokinetics and pharmacodynamics, pp. 222-239.
  35. Rodriguez, I., Kilborn, M. J., Liu, X. K., Pezzullo, J. C., & Woosley, R. L. (2001). Drug-induced QT prolongation in women during the menstrual cycle. JAMA: the Journal of the American Medical Association, 285, 1322-1326. PubMed
  36. Ebert, S. N., Liu, X-K, & Woosley, R. L. (1998). Female gender as a risk factor for drug-induced cardiac arrhythmias: evaluation of clinical and experimental evidence. Journal of Women's Health, 5, 547-557. PubMed
  37. Anthony, M. (2005). Male/female differences in pharmacology: safety issues with QT-prolonging drugs. Journal of Women's Health, 14, 47-52. PubMed
  38. Harris et al. Gender effects in pharmacokinetics and pharmacodynamics, pp. 222-239.
  39. U.S. Department of Health and Human Services, Food and Drug Administration. (2004). Draft guidance. Guidance for industry: Pharmacokinetics in pregnancy-study design, data analysis, and impact on dosing and labeling. Retrieved January 20, 2006, from http://www.fda.gov/cder/guidance/3625fnl.pdf.
  40. Harris et al. Gender effects in pharmacokinetics and pharmacodynamics, pp. 222-239.
  41. U.S. Department of Health and Human Services, Food and Drug Administration. (2004). Draft guidance. Guidance for industry: Pharmacokinetics in pregnancy-study design, data analysis, and impact on dosing and labeling. Retrieved March 7, 2006, from http://www.fda.gov/cder/guidance/5917dft.htm.
  42. Bologa, M., Tang, B., Klein, J., Tesoro, A., & Koren, G. (1991). Pregnancy-induced changes in drug metabolism in epileptic women. Journal of Pharmacology and Experimental Therapeutics, 257, 735-40. PubMed
  43. Wadelius, M., Darj, E., Frenne, G., & Rane, A. (1997). Induction of CYP2D6 in pregnancy. Clinical Pharmacology and Therapeutics, 62, 400-407. PubMed
  44. Harris et al. Gender effects in pharmacokinetics and pharmacodynamics, pp. 222-239.
  45. Ibid., pp. 222-239.
  46. Plymate et al. Sex hormone-binding globulin changes during the menstrual cycle. Cited in: Institute of Medicine Committee on Understanding the Biology of Sex and Gender Differences. (2001). Exploring the biological contributions to human health: Does sex matter? (T. M. Wizeman & M. L . Pardue, Eds.). Washington, DC: National Academy Press, p. 123
  47. Harris et al. Gender effects in pharmacokinetics and pharmacodynamics, pp. 222-239.
  48. Kashuba, A. D. & Nafziger, A. N. (1998). Physiological changes during the menstrual cycle and their effects on the pharmacokinetics and pharmacodynamics of drugs. Clinical Pharmacokinetics, 34, 203-218. PubMed
  49. Berg, M. J. (1998). Gender-specific prescribing: medications and the menstrual cycle. Journal of Gender-Specific Medicine, 1, 17-19.
  50. Paine et al. Do men and women differ in proximal small intestinal CYP3A or P-glycoprotein expression? pp. 426-433
  51. Harris et al. Gender effects in pharmacokinetics and pharmacodynamics, pp. 222-239.
  52. Mattison, D. R. (2004). Sex matters in pharmacology: Principles of pharmacology for women. In: Primary Care for Women (P. C. Leppert, & J. F. Peipert, Eds.). 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins, pp. 112-117.
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