Curriculum vitae

CURRICULUM VITAE
RICHARD F. BERGSTROM, PH.D.
OCTOBER 2011
PERSONAL DATA
EDUCATION
Taylor University, Upland, IN, Major: Chemistry University of Pittsburgh, School of Pharmacy, Pittsburgh, PA, Bachelor of Butler University, College of Pharmacy, Indianapolis, IN, Master of Science in Pharmacology (Thesis Advisor: Dr. James E. Berger and Dr. John F. Quay at Eli Lilly and Company) University of Michigan, School of Pharmacy, Ann Arbor, MI, Doctor of Philosophy Degree Pharmaceutical Chemistry (Pharmacokinetics) (Thesis Advisor: Dr. John G. Wagner) EMPLOYMENT:
Butler University College of Pharmacy and Health Sciences Professor or Pharmaceutical Sciences and Director of Research Alliances Eli Lilly and Company, Indianapolis, IN, Research Global Pharmacokinetics Pharmacodynamics and Trial Simulations, Lilly Research Laboratories Research Fellow Eli Lilly and Company, Indianapolis, IN, Staff Member Lilly Laboratory for Clinical Research, Indiana University Hospital. Eli Lilly and Company, Indianapolis, IN, Staff Member Lilly Laboratory for Clinical Research, Wishard Memorial Hospital. Eli Lilly and Company, Indianapolis, IN, Parenteral Products Development, Montefiore Hospital, Pittsburgh, PA, Pharmacy Staff Intern CONSULTING APPOINTMENTS
RFBergstrom PK/PD Consulting LLC, Indianapolis, IN, Principal Assignments/Projects: Centurion Clinical Research, LLC (2009); Eli Lilly and Company (2010), EMD Millipore, the Life Science Division of Merck KGaA of Germany (2010-present), Transpharma Medical Ltd (2010-present); BetaCat Pharmaceuticals, LLC (2011-present) Anson Group Consulting LLC, Indianapolis, IN, Regulatory Advisor YourEncore, Indianapolis, IN, PK/PD and Due Diligence Consulting Assignments/Projects: Eli Lilly and Company, Roche ACADEMIC APPOINTMENTS
Adjunct Assistant Professor of Pharmacology and Toxicology, Indiana University School of Medicine, Division of Pharmacology and Toxicology Adjunct Professor of Medicine, Indiana University School of Medicine, Professor of Pharmaceutical Sciences and Director of Research Alliances, Butler University, College of Pharmacy and Health Sciences PHARMACY LICENSE
HONORS AND AWARDS
Lilly Research Laboratories, President’s Recognition Award Fellow - American Association of Pharmaceutical Scientists Food and Drug Administration Commissioner's Special Citation, American Foundation for Pharmaceutical Education, Manufacturing and Industrial Pharmacy Fellow, The University of Michigan Phi Lambda Upsilon Honorary Chemical Society (1978) Merck Award Outstanding Achievement in Pharmaceutical Chemistry, Rho Chi Scholarship Award, Pharmacy Honor Society SCIENTIFIC AND RESEARCH ACTIVITES
Drug Development PK/PD Project Responsibilities
1980-1982:
Benoxaprofen, Oraflex® non-steroidal anti-inflammatory NDA Submission, Drug Interactions (probenecid, ASA), Protein Binding Nizatidine, LY139037, Axid®, Axid-AR™ United States NDA 20-555 (1996), PK/PD Consultant for Whitehall/Robbins prescription to OTC switch Areas of PK/PD Research: Clinical Pharmacology (Gastric Acid pH Effect and Sectrtion), Absolute Bioavailability (IV versus oral), Drug Interactions, Human 14C-labeled metabolism (IV and oral), Bioavailability/Bioequivalence (150 mg vs 300 mg capsules) Fluoxetine, LY110140, Prozax®, Serafem® Prozac Weekly™ United States NDA 18-936 (1985), European Countries MAA (decentralized individual submissions), and Japan NDA (2001). Areas of PK/PD Research: Clinical Pharmacology, Enantiomer Selective Pharmacokinetics and Metabolism, Human 14C-labeled metabolism studies, Drug-Interactions (tricyclics, CYP2D6 inhibitor, CYP1A2 substrates terfenadine), Special Populations Studies (elderly, renally impaired, hepatically impaired, pediatric, adolescent), Bioavailability/Bioequivalence (alternative dosage forms: liquid, tablets, capsule strengths, delayed release Prozac Weekly capsules), Population Pharmacokinetics. Olanzapine, LY170053, Zyprexa®, Symbyax®, Zyprexa® Zydis™, Relprevv™ NDA 20-592 (olanzapine original NDA), Clinical Pharmacology, Drug Interactions (theophylline, impramine), Bioavailability/Bioequivalence (tablets vs capsules), Special Populations (renally impaired, elderly, hepatically impaired), Population Pharmacokinetics NDA 21-086 (olanzapine rapidly disintegrating tablet, Zydis) Bioavailability/Bioequivalence (Zydis vs standard oral dose) NDA 21-520 (olanzapine fluoxetine fixed dose combinations) NDA 21-253 (olanzapine intramuscular injection) rapidly acting IM injection, PK/PD for IM administration, bioavailability/bioequivalence. NDA 22-173 (olanzapine pamoate depot) PK/DP of a depot drug product Duloxetine, LY248686, Cymbalta®, Yentreve® NDA 21-147 (2001, delayed release capsules), MAA Clinical Pharmacology, Special Populations, Bioavailability/Bioequivalence, Drug Interactions, Metabolism (CYP2D6, CYP1A2, inhibitors and other substrates)
Editorial Advisory Board
2000-2002:

Journal Reviewer
AAPS Journal
AAPS PharmSciTech
Antimicrobial Agents and Chemotherapy
Biopharmaceutics and Drug Disposition British Journal of Clinical Pharmacology Clinical Pharmacology and Therapeutics Drug Metabolism and Disposition Journal of Pharmaceutical Sciences Pharmaceutical Research SCIENTIFIC AND PROFESSIONAL MEMBERSHIPS
American Pharmacists Association
Academy of Pharmaceutical Sciences
American Association of Pharmaceutical Scientists
• Primary Section: Pharmacokinetics Pharmacodynamics • PPDM Section Abstract Screener (1990) • PPDM Executive Committee (1991-1993) • AAPS Strategic Planning Committee (1993) • AAPS Executive Council Member at Large (1996-1998) • AAPS Chair Publication Board (2001-2002) • AAPS Nominations Program Review Team (2004) • AAPS Fellows Selection Committee (2006 – 2008) • PPDM Fellows Review Committee (2009 – 2010) Indiana Ohio Discussion Group
• Founding Committee (1987), Chair (1988-89) American College of Clinical Pharmacology
ASCPT American Society for Clinical Pharmacology and Therapeutics
International Society for the Study of Xenobiotics
TEACHING ACTIVITIES
Indiana University School of Medicine
F813
Clinical Pharmacokinetics (Indiana University School of Medicine, Department of Pharmacology and Toxicology): graduate level course taught every other year from 1986 until present covering the fundamental basis of PK/PD as they apply to new drug development. Physiologic Disposition of Drugs and Pharmacogenomics (Indiana University School of Medicine, Department of Pharmacology and Toxicology): graduate level course taught every other year from 1985 until present covering the fundamentals of PK, metabolism, bioanalytical analysis, and genomics
Butler University College of Pharmacy and Health Sciences
RX422
Industrial Pharmacy: Pre-formulation and Product Development BIBLIOGRAPHY - ABSTRACTS
Kay, D.R., Wexler, D., Agabeyoglu, I.T., Bergstrom, R.F., Sakmar, E., and Wagner, J.G. Clinical Pharmacokinetics of Prednisolone and Prednisone in Immune Disease Patients Receiving Chronic Prednisone Therapy. Abstracts of Am. Pharm. Assn. Acad. Pharm. Sci. 11(2):96, Nov. 18, 1981. Bergstrom, R.F., DeSante, K.A., Nash, J.F., and Ridolfo, A.S. Pharmacokinetic Interaction of Benoxaprofen and Probenecid. Abstracts of Am. Pharm. Assn. Acad. Pharm. Sci., 11(2):137, Nov. 18, 1981. Bergstrom, R.F., Galloway, J.A., Root, M.A., and Spradlin, C.T. The Bioavailability Index for Insulin. Toronto International Workshop on Insulin and Portable Delivery Systems, Toronto, Canada, June 9, 1982. Brier, G.L., Bergstrom, R.F., Black, H.R., Reynolds, J., Siders, J.A., and Bahn, N.A. Evaluation of the Dynatech Microelisa Reader for Anaerobic M.I.C. Determination. Abstract ICAAC, October, 1982. McNay, J.L., Bechtol, L.D., Miner, D.S., and Bergstrom, R.F. Hydroxylation Activity Determines Disposition of Penbutolol in Man. Abstracts: II World Conference on Clin. Pharmacol. Ther., Washington, D.C.: Pharmacokinetics II (79):14, Aug. 1, 1983. DeSante, K., Wolen, R., Bergstrom, R., Hatcher, B., Spradlin, C., and Lemberger, L. Determination of the Bioavailability and Dose Proportionality of Nabilone Using Stable Isotope Technology. Abstracts: II World Conference on Clin. Pharmacol. Ther., Washington, D.C.: Pharmacokinetics IV (280):48, Aug. 3, 1983. Callaghan, J.T., Bergstrom, R.F., and Obermeyer, B.D. Pharmacokinetic-Pharmacodynamic Evaluation of Nizatidine, A New H2-Antagonist. Abstracts: II World Conference on Clin. Pharmacol. The., Washington, D.C.: Gastrointestinal, Histamine and Antagonists I (402):69, August 2, 1983. Farid, N.A., Ziege, E.A., Bergstrom, R.F. and Lemberger, L. Physiologic Disposition and the Steady State Pharmacokinetics of Tomoxetine. Abstracts: II World Conference on Clin. Pharmacol. Ther., Washington, D.C.: Metabolism (663):114, August 4, 1983. Aronoff, G.R., Pottrate, S.T., Sloan, R.S., Bergstrom, R.F. and Lemberger, L. Elimination Kinetics of Fluoxetine in Patients with Impaired Renal Function. Abstracts: II World Conference on Clin. Pharmacol. Ther., Washington, D.C.: Antidepressants (515):88, August 4, 1983. 10. Bergstrom, R.F., Farid, K.Z., McClurg, J.E., and Lemberger, L. The Pharmacokinetics of Fluoxetine in Elderly Subjects. Abstracts: II World Conference on Clin. Pharmacol. Ther., Washington, D.C.: Drugs and the Elderly (699):120, August 4, 1983. 11. Bergstrom, R., Wolen, R., Dhahir, P., Hatcher, B., Werner, N. and Lemberger, L. Effect of Food on the Absorption of Fluoxetine in Normal Subjects. Abstracts of Am. Pharm. Assn. Acad. Pharm. Sci. 14(1):100, May 10, 1984. 12. Knadler, M.P., Rubin, A., Bergstrom, R.F., and Callaghan, J.T. Effects of Gelusil, Charcoal, and Propantheline on the Bioavailability of the H2-Blocker Nizatidine. The Pharmacologist 26(3): 236, Abstract 599, 1984. 13. Farid, N.A., Bergstrom, R.F., Ziege, E.A., and Lemberger, L. The Effect of Food on the Relative Bioavailability of Tomoxetine and Intersubject Differences in Metabolism. p 1118 #4137, FASEB 69th Annual Meeting, Anaheim, CA, April, 1985. 14. Knadler, M.P., Bergstrom, R.F., Callaghan, J.T. and Rubin, A. Nizatidine, An H2- Blocker: Its Metabolism and Dispostiion in Man. The Pharmacologist 27(3): 180, Abstract 383, 1985. 15. Rowe, H., Lemberger, L., Bergstrom, R., Hardison, D., Barrett, J. The Effect of Co- administration of Fluoxetine and Diazepam on Psychomotor and Physiologic Responses. The Pharmacologist 27(3): 196, Abstract 462, 1985. 16. Bergstrom, R.F., Wolen, R.L., Lemberger, L., Dhahir, P., and Barrett, J.L. Fluoxetine Single Dose-Multiple Dose Kinetics. Abstracts of Am. Pharm. Assn. Acad. Pharm. Sci. 15(2):137, October 21, 1985. 17. DeLong, A.F., Bergstrom, R.F., Lemberger, L., Barrett, J.L., and Doedens, D.J. Fluoxetine-Secobarbital Interaction in Humans. Abstracts of Am. Pharm. Assn. Acad. Pharm. Sci. 15(2):149, October 21, 1985. 18. Callaghan, J.T., Farid, N.A., Bergstrom, R.F., Ziege, E.A., and Marshall, W.S. Clinical Observations and the Single Dose and Steady State Pharmacokinetics of LY171883, A New Leukotriene D4-Antagonist, In Man., Abstract 212 in Annals of Allergy 55(part II):278, October, 1985. 19. Bergstrom, R.F., van Lier, R.B.L., Lemberger, L., and Tenbarge, J.L. Absolute Bioavailability of Fluoxetine in Beagle Dogs. Abstracts of Am. Pharm. Assn. Acad. Pharm. Sci. 16(1):126, March 17, 1986. 20. Bergstrom, R.F., Wolen, R.L., Lemberger, L., Tenbarge, J.L., and Masco, H.L. Fluoxetine Steady State Pharmacokinetics in Depressed Patients. Abstracts of Am. Pharm. Assn. Acad. Pharm. Sci. 16(1):125, March 17, 1986. 21. Aronoff, G.R., Sloan, R.S., Bopp, R.J., Walters, J.B., Bergstrom, R.F., and Callaghan, J.T. Nizatidine Kinetics in Patients with Renal Insufficiency. Clin. Pharmacol. Ther. 39(2):178, 1986. 22. Callaghan, J.T., Bergstrom, R.F., Knadler, M.P., and Rubin, A. Nizatidine (N) Disposition in Elderly Subjects (E). Clin. Pharmacol. Ther. 39(2):185, 1986. 23. Lemberger, L., Farid, N.A., Bergstrom, R.F., and Wolen, R.L. The Pharmacology and Physiologic Disposition of Fluoxetine. Satellite - Drugs Regulating Food Intake and Energy Balance, Rome, Italy, September 22-25, 1986. 24. Bergstrom, R.F., Lemberger, L., and Hatcher, B.L. Evaluation of the Kinetics of Morphine When Administered Alone or After Fluoxetine. Am. Assn. Pharm. Sci. 1st Annual Meeting, Washington, D.C., November 3, 1986, Pharm. Res 3(6):106S, 1986. 25. Farid, N.A., Bergstrom, R.F., Lemberger, L., Ziege, E.A., Tenbarge, J., Wolen, R.L., and Dhahir, P.H. Studies on the Disposition of Fluoxetine at Steady State in Man with the Aid of Stable and Radioactive Isotopes. Collegium Internationale Neuropsycho Pharmaologieum, 15th CINP Congress, San Juan, Puerto Rico, December 14-17, 1986. 26. Murdoch, A.A., Shamblen, E.C., Lasseter, K.C., Rubin, A., Knadler, M.P., Bergstrom, R.F., and Callaghan, J.T. Nizatidine Pharmacokinetics in Hepatic Disease. Associates of Clinical Pharmacology, Spring Meeting, J. Clin. Res. Drug Dev. 1 _:233, 1987. 27. Bergstrom, R.F., Lemberger, L., Kuhlthau, J.M., and Kisicki, J.C. Fluoxetine Bioequivalence 10 vs 20 mg Capsules. Am. Assn. Pharm. Sci. 3rd Annual Meeting, Orlando , FL, November 3, 1988, Pharm. Res. 5(10):S-166, 1988. 28. Bergstrom, R.F., Lemberger, L., Russell, D.G., and Kisicki, J.C. Fluoxetine Pharmacokinetics in Obese Women. Am. Assn. Pharm. Sci. 3rd Annual Meeting, Orlando , FL, November 3, 1988, Pharm. Res. 5(10):S-158, 1988. 29. Obermeyer, B.D., Bergstrom, R.F., Callaghan, J.T., Golichowsky, A., Knadler, M.P., and Rubin, A. Secretion of Nizatidine into Human Breast Milk. The Pharmacologist 30(3): 1988. 30. Feher, M.D., Lucas, R.A., Farid, N.A., Idle, J.R., Bergstrom, R.F., Lemberger, L., and Sever, P.S. Single Dose Pharmacokinetics of Tomoxetine in Poor and Extensive Metabolisers of Debrisoquine. Br. J. Clin. Pharmacol. 26:231, 1988. 31. Wolen, R.L., Bergstrom, R.F., Tenbarge J.B., and Lemberger, L. Fluoxetine Enantiomer Disposition in Plasma and Urine of Normal Subjects and Patients. Am. Assn. Pharm. Sci. 4th Annual Meeting, Atlanta, GA, October 25, 1989, Pharm. Res. 6(9):S-221, 1989. 32. Bergstrom, R.F., Lemberger, L., Kuhlthau, J.M., and Kisicki, J.C. Fluoxetine: Comparative Bioequivalence Studies with 60 mg Capsules and Tablets. Am. Assn. Pharm. Sci. 4th Annual Meeting, Atlanta, GA, October 25, 1989, Pharm. Res. 6(9):S-227, 1989. 33. Schwinghammer, T.L., Kroboth, P.D., Bergstrom, R.F., and Callaghan, J.T. The Effect of Study Design on the Pharmacodynamics of Nizatidine. Am. College of Clin. Pharm. Annual Meeting, August 5, 1990, Pharmacotherapy 10(3):236, 1990. 34. Bergstrom, R.F., Lemberger, L., Cerimele, B.J., Wolen, R.L., and Kisicki, J.C. Relative Bioequivalence of a Fluoxetine Oral Solution Versus the Marketed Capsule. Am. Assn. Pharm. Sci. 5th Annual Meeting, Las Vegas, NV, November 5, 1990, Pharm. Res. 7(9):S-251, 1990. 35. Bergstrom, R.F., Lemberger, L., and Peyton, A.L. Drug Interaction Between Fluoxetine and the Tricyclic Antidepressants Imipramine and Desipramine. Am. Assn. Pharm. Sci. 5th Annual Meeting, Las Vegas, NV, November 5, 1990, Pharm. Res. 7(9):S-254, 1990. 36. Bergstrom, R.F., Beasley, C.M. Jr, Levy, N.B., Dubey, A.K., Blumenfield, M., Goodman, A., and Solomon, R.J. Fluoxetine Pharmacokinetics after Daily Doses of 20-mg Fluoxetine in Patients with Severely Impaired Renal Function. Am. Assn. Pharm. Sci. 6th Annual Meeting, Washington, DC, November 18, 1991, Pharm. Res. 8(10):S-294, 1991. 37. Peyton, A.L., Lemberger, L., Rutkowski, K., Wolen, R.L., Bergstrom, R.F., Haynes, T., and Ziege, E.A. Differential Disposition and Protein Binding of Fluoxetine and Norfluoxetine Enantiomers after Administration of Racemic Fluoxetine. Am. Assn. Pharm. Sci. 6th Annual Meeting, Washington, DC, November 18, 1991, Pharm. Res. 8(10):S-308, 1991. 38. Bergstrom, R.F., Wolen, R.L., Peyton, A.L., Goodwin, M.R., Kasper, S.C., Barton, R., Schwertschlag U., and Lemberger, L. Pharmacokinetics of R- and S-Fluoxetine Enantiomers and the Effect of P450IID6 Activity on their Disposition in Man. Am. Assn. Pharm. Sci. 7th Annual Meeting, San Antonio, TX, November 18, 1991, Pharm. Res. 9(10):S-306, 1992. 39. Seger, M.E., Bergstrom, R.F., Schwertschlag, U.S., and DeLong, A.F. Pharmacokinetics of Dapoxetine after Single Oral Doses Given During A Phase I Clinical Evaluation. Am. Assn. Pharm. Sci. 7th Annual Meeting, San Antonio, TX, November 15-19, 1992, Pharm. Res. 9(10):S-309, 1992. 40. Bergstrom, R.F., Callaghan, J.T., Levine L.R., and Cerimele, B.J. The Interaction of Ethanol and the H2-Receptor Antagonist Nizatidine in Normal Male Volunteers. Am. Assn. Pharm. Sci. 8th Annual Meeting, Orlando, FL, November 14-18, 1993, Pharm. Res. 10(10):S-301, 1993. 41. Kurtz, D.L., Bergstrom, R.F., Goldberg, M.J., and Cerimele, B. J. Drug Interaction Between Sertraline and Desipramine or Imipramine. Am. Col. Clin. Pharmacol. 25th Annual Meeting, Orlando, FL, October 8, 1994, J. Clin. Pharmacol. 34:1030, 1994. 42. Nyhart, Jr., E.H., Cerimele, B.J., Kassahun, K., Callaghan, J.T., Bergstrom, R.F., and Radtke, D.B. Olanzapine: An Initial Assessment of the Bioequivalence of Capsule and Tablet Formulations. Am. Assn. Pharm. Sci. 10th Annual Meeting, Miami, FL, November 6-9, 1995, Pharm. Res. 12(9):S-415, 1995. 43. Patel, B.R., Nyhart, Jr., E.H., Callaghan, J.T., Kassahun, K., Hunt, T.L., and Bergstrom, R.F. Combined population Pharmacokinetic Analysis of Olanzapine in Healthy Volunteers. Am. Assn. Pharm. Sci. 10th Annual Meeting, Miami, FL, November 6-9, 1995, Pharm. Res. 12(9):S-360, 1995. 44. Bergstrom, R.F., Callaghan, J.T., Cerimele, B.J., Nyhart, Jr. E.H., Kassahun, K., and Hunt T.L. Pharmacokinetics of Olanzapine in Elderly and Young. Am. Assn. Pharm. Sci. 10th Annual Meeting, Miami, FL, November 6-9, 1995, Pharm. Res. 12(9):S-358, 1995. 45. Patel, B.R., Kurtz, D.L., Callaghan, J.T., Beasley, C.M., and Bergstrom, R.F. Effect of Smoking and Gender on Population Pharmacokinetics of Olanzapine. Am. Psych. Assn. Meeting, New York, NY, May 4-9, 1996. 46. Levy, N.B., Blumenfield, M., Beasley, C.M., Dubey, A.K., Solomon, R.J., Todd, R., Goodman, A. and Bergstrom R.F. Fluoxetine is Safe and Efficacious in Depressed Hemodialysis-Patients. Psychosomatics 37(2):211-211, 1996. 47. Bergstrom, R.F., Callaghan, J.T., Cerimele, B.J., Radtke, D.B., Tatum, D.E., Nyhart, Jr. E.H., and Potkin SG. Pharmacokinetics of Olanzapine in Caucasian, Chinese, and Japanese Subjects. Am. Assn. Pharm. Sci. Annual Meeting, Seattle, WA, October 27-31, 1996, Pharm. Res. 13(9):S-424, 1996. 48. Bergstrom, R.F., Goldberg, M.J., Cerimele, B.J., Hatcher, B.L., and Simcox, E.A. Lack of a Pharmacokinetic Drug Interaction Between Fluoxetine and Terfenadine. Am. Assn. Pharm. Sci. Annual Meeting, Seattle, WA, October 27-31, 1996, Pharm. Res. 13(9):S-433, 1996. 49. Patel, B.R., Kurtz, D. L., Callaghan, J.T., Beasley Jr., C.M., Bergstrom, R.F. Effects of Smoking and Gender on Population Pharmacokinetics of Olanzapine in a Phase III Clinical Trial. PPDM-8064 Am. Assn. Pharm. Sci. Annual Meeting, Seattle, WA, October 27-31, 1996, Pharm. Res. 13(9):S-408, 1996. 50. Goldberg, M.J. Bergstrom, R.F., Cerimele, B.J., Thomasson, H.R., Hatcher, B.L., and Simcox, E.A. Fluoxetine Effects on Pindolol Pharmacokinetics. Am. Soc. Clin. Pharmacol and Ther. Annual Meeting, San Diego, CA, March 1997, Clin. Pharmacol Ther. 61(2):178, 1997. 51. Mäenpää, J., Wrighton, S., Bergstrom, R., Cerimele, B., Tatum, D., Hatcher, B., and Callaghan, J.T. Pharmacokinetic and Pharmacodynamic Interactions Between Fluvoxamine and Olanzapine. Am. Soc. Clin. Pharmacol and Ther. Annual Meeting, San Diego, CA, March, 1997, Clin. Pharmacol Ther. 61(2):225, 1997. 52. Maya J.F., Callaghan, J.T., Bergstrom, R.F., Cerimele, B.J., Kassahun, K., Nyhart Jr, E.H., and Brater, D.C. Olanzapine and Warfarin Drug Interaction. Am. Soc. Clin. Pharmacol, Ther. Annual Meeting, San Diego, CA, March, 1997, Clin. Pharmacol Ther. 61(2):182, 1997. 53. Goldberg, M.J. Bergstrom, R.F., Smith, B.P., Simcox, E.A., Thomasson, H.R., and Shipley, L.A. Melatonin: Pharmacokinetics and Effect on Body Temperature in Men, Am. Sleep Disorders Association, Sleep Res. Soc. 11th Annual Meeting, San Francisco, CA, June 10-15, 1997. 54. Bergstrom, R.F., Macias, W.L., Cerimele, B.J., Kassahun K., Hatcher, B.L., Radtke D.B., Tatum, D.E., and Callaghan J.T. Steady State Olanzapine Concentrations Do Not Affect Theophylline Pharmacokinetics. Am. Assn. Pharm. Sci. Annual Meeting, Boston, MA, November 2-6, 1997, (Abstract 3427) Pharm. Res. 14(11):S-605, 1997. 55. Bergstrom R., Mitchell M., Hatcher B., Witcher J., Jewell H., Richards J., and McEwen J. Pharmacokinetics of Olanzapine in Healthy Male Subjects Following Intramuscular Administration of Single Doses. Am. Assn. Pharm. Sci. Annual Meeting, San Francisco, CA November 15-19, 1998, (Abstract 2052) PharmSci Supplement 1(1):S-152, 1998. http://www.aapsj.org/abstracts/AM_1998/2052.html 56. Cerimele B., Bergstrom R., Macias W., Callahgan J., and Miller J. Misapplication of Bioequivalence Paradigm to Drug-Interaction Studies. Am. Assn. Pharm. Sci. Annual Meeting, San Francisco, CA November 15-19, 1998, (Abstract 3342) PharmSci Supplement 1(1):S-459, 1998. http://www.aapsj.org/abstracts/AM_1998/3797.html 57. Witcher J.W., Bergstrom R.F., Cerimele B.J., Hatcher B.L., Jewell H., Hemingway J., Ratnasingam L,. and Mitchell M. Pharmacokinetics and Bioequivalence of Olanzapine Rapidly-Disintegrating Tablets. Am. Assn. Pharm. Sci. Annual Meeting, San Francisco, CA November 15-19, 1998, (Abstract 3431) PharmSci Supplement 1(1):S-487, 1998. http://www.aapsj.org/abstracts/AM_1998/3431.html 58. Cerimele B., Bergstrom R., Callaghan J., and Clancy A. Statistical Methodology for Assessing and Comparing Pharmacokinetic Dose-Response Relationships. Am. Assn. Pharm. Sci. Annual Meeting, San Francisco, CA November 15-19, 1998, (Abstract 3797) PharmSci Supplement 1(1):S-599, 1998. http://www.aapspharmsci.org/scientificjournals/pharmsci/am_abstracts/1998/abstracts/3797.html 59. Bergstrom R, Mitchell M, Jewell H, Richards J, McEwan J, Hatcher B. Examination of the safety, tolerance, and pharmacokinetics of intramuscular (IM) olanzapine compared to oral olanzapine in healthy subjects. Schizophrenia Research 36(1-3):305-306, 1999 60. Wright P, Keisler G, Mitchell M, Jewell H, Hatcher B, Brook S, Bergstrom R. Safety and efficacy of intramuscular (IM) olanzapine in patients with acute nonorganic psychosis. Schizophrenia Research 36(1-3):318, 1999. 61. Wright P, Jewell H, Mitchell M, Hatcher B, Brook S, Kiesler G, Bergstrom R. A preliminary study of the safety, efficacy, and pharmacokinetics of intramuscular (IM) olanzapine in patients with acute nonorganic psychosis. Schizophrenia Research 36(1-3):318. 1999 61. Bergstrom R, Mitchell M, Cerimele B, Hatcher B, Jewell H, Satterwhite J, Harry J. Direct Comparison of IM and Oral Olanzapine Pharmacokinetics in Healthy Male Subjects. AAPS Annual Meeting, New Orleans, LA November 1999, AAPS PharmSci 1(4):Abstract 3206, 1999. http://www.aapsj.org/abstracts/AM_1999/2363.htm 62. Satterwhite J, Cerimele B, Hatcher B, Tatum D, Thomasson H, Callaghan J, Bergstrom R. Pharmacokinetic/Pharmacodynamic Drug Interation Evaluation of the Coadministration of Intramuscular Olanzapine with Intramuscular Lorazepam. AAPS Annual Meeting, New Orleans, LA November 1999, AAPS PharmSci 1(4):Abstract 2072, 1999. http://www.aapsj.org/abstracts/AM_1999/1172.htm 63. Sathirakul K, Teng L, Bergstrom RF, Wise SD. Olanzapine: Assessment of the Pharmacokinetics in Chinese and Caucasian Subjects. AAPS Annual Meeting, Indianapolis, IN November 2000, AAPS PharmSci 2(4):Abstract 1861, 2000. http://www.aapsj.org/abstracts/AM_2000/3315.htm 64. Kuan HY, Reddy S, Zhang L, Knadler MP, Skinner M, Bergstrom RF. Duloxetine Single- And Multiple-dose Pharmacokinetics In Healthy Subjects AAPS Annual Meeting, Toronto Ontario, Canada, November 2002, AAPS PharmSci 4(4):Abstract T3243, 2002. http://www.aapsj.org/abstracts/AM_2002/AAPS2002-001600.pdf 65. Kothare PA, Bergstrom RF, Lee KB, Sinha V. Pharmacokinetic Analysis Of Fluoxetine Using Population Analyses In Caucasian Subjects With Major Depressive Disorder. AAPS Annual Meeting, Salt Lake City, Utah, November 2003, AAPS PharmSci 5(S1):Abstract T2347, 2003. http://www.aapsj.org/abstracts/Am_2003/AAPS2003-002163.PDF 66. Small D, Loghin C, Lucas R, Knadler MP, Zhang L, Chappell J, Bergstrom R, Callaghan JT. Pharmacokinetic Evaluation of Combined Duloxetine and Fluvoxamine Dosing in CYP2D6 Poor Metabolizers. ASCPT Annual Meeting, Orlando, Florida, March 2-6, 2005. Clin Pharmacol Ther 77: P37-P37; doi:10.1016/j.clpt.2004.12.036 http://www.nature.com/clpt/journal/v77/n2/pdf/clpt2005150a.pdf 67. Sinha VP, Dai Y, Kothare P, Lee KB, Kurtz DL, Bergstrom RF. Population Pharmacokinetic Analyses of Fluoxetine and Norfluoxetine in Patients. ASCPT Annual Meeting, Baltimore, Maryland, March 8-11, 2006. Clin Pharmacol Ther 79: P27-P27; doi:10.1016/j.clpt.2005.12.100 http://www.nature.com/clpt/journal/v79/n2/pdf/clpt2006114a.pdf 68. Bergstrom RF; Kryzhanovskaya L; Martenyi F; Osuntokun OO; Quinlan T; Tohen M; Wang WV; Bowden CL; Smulevich AB. Olanzapine Plus Carbamazepine Versus Carbamazepine Plus Placebo in the Treatment of Mania: A 6-week, Double-blind, Randomized Trial Fifth European Stanley Conference on Bipolar Disorder (ESCBD/Stanley); 5-7 October 2006; Barcelona, Spain 69. Bergstrom RF; Kryzhanovskaya L; Osuntokun OO; Tohen M; Wang WV; Bowden CL; Smulevich AB; Quinlan T; Martenyi F. Olanzapine Plus Carbamazepine Versus Carbamazepine in the Treatment of Mania: A 6-week, Double-blind, Randomized Trial. 45th American College of Neuropsychopharmacology; December 3-7, 2006; Hollywood, FL 70. Kurtz D, Bergstrom R, McDonnell DP, Mitchell M. Pharmacokinetics (PK) of Multiple Doses of Olanzapine Long Acting Injection (OLAI), an Intramuscular (IM) Depot Formulation of Olanzapine (OLZ), in Stabilized Patients with Schizophrenia. Society of Biological Psychiatry 63rd Annual Convention, Washington, DC Biological Psychiatry 63(7):S1:288S May 3, 2008. 71. Garhyan P., Kurtz D. L., McDonnell D. P., Bergstrom R. F. Population Pharmacokinetic Modeling of Long Acting Intramuscular Injection of Olanzapine Pamaote Depot. American Association of Pharmaceutical Scientists, Annual Meeting 2008. http://www.aapsj.org/abstracts/AM_2008/AAPS2008-001838.PDF BIBLIOGRAPHY - JOURNAL PUBLICATIONS
Bergstrom, R.F., Fites, A.L., and Lamb, J.W. Stability of Parenteral Solutions of Tobramycin Sulfate. Am. J. Hosp. Pharm. 32:887-888, 1975. Bergstrom, R.F., and Fites, A.L. Stability of Erythromycin Gluceptate in Sodium Chloride Injection and Dextrose Injection. Am. J. Hosp. Pharm. 32:241, 1975. Agabeyoglu, I.T., Bergstrom, R.F., Gillespie, W.R., Wagner, J.G., and Kay, D.R. Plasma Protein Binding of Prednisolone in Normal Volunteers and Arthritic Patients. Europ. J. Clin. Pharmacol. 16:339-404, 1979. Bergstrom, R.F., Kay, D.R., and Wagner, J.G. High-Performance Liquid Chromatographic Determination of Penicillamine in Whole Blood, Plasma, and Urine. J. Chromatogr. Biomed. Appl. 222:445-452, 1981. Bergstrom, R.F., Kay, D.R., and Wagner, J.G. The In-Vitro Loss of Penicillamine in Plasma, Albumin Solution, and Whole Blood: Implications for Pharmacokinetic Studies of Penicillamine. Life Sciences 27:189-198, 1981. Wagner, J.G., Wexler, D., Agabeyoglu, I.T., Bergstrom, R.F., Sakmar, E., and Kay, D.R. Plasma Protein-Binding Parameters of Prednisolone in Immune Disease. J. Lab. Clin. Med. 97:487-501, 1981. Bergstrom, R.F., Kay, D.R., and Wagner, J.G. The Pharmacokinetics of Penicillamine in a Female Mongrel Dog. J. Pharmacokin. Biopharm. 9:603-621, 1981. Bergstrom, R.F., Kay, D.R., and Wagner, J.G. Penicillamine Kinetics in Normal Subjects. Clin. Pharmacol. Ther. 30:404-413, 1981. Ridolfo, A.S., Carmichael, R.H., DeSante, K.A., Bergstrom, R.F., Rockhold, F.W., Nash, J.F., and Fineberg, S.E. Clinical Pharmacology of Benoxaprofen. Europ. J. Rheum. Inflam. 5:(2):98-112, 1982. 10. Lemberger, L., Bergstrom, R., Aronoff, G., Farid, N. and Wolen, R. Specific Serotonin Uptake Blockers: Clinical Pharmacology and Antidepressant Action. Clin. Neuropharmacol. 7(S1):324-325, 1984. 11. Aronoff, G.R., Bergstrom, R.F., Prottratz, S.T., Sloan, R.S., Wolen, R.L., and Lemberger, L. Fluoxetine Kinetics and Protein Binding in Normal and Impaired Renal Function. Clin. Pharmacol. Ther., 36:138-144, 1984. 12. Callaghan, J.T., Bergstrom, R.F., Obermeyer, B.D., King, E.P. and Offen, W.W. Intravenous Nizatidine Kinetics and Acid Suppression. Clin. Pharmacol. Ther. 37(2):162-165, 1985. 13. Lemberger, L., Rowe, H., Bergstrom, R.F., Farid, K.Z., Enas, G.G. The Effect of Fluoxetine on the Psychomotor Performance, Physiologic Response, and Pharmacokinetic Disposition of Ethanol. Clin. Pharmacol. Ther. 37:658-664, 1985. 14. Farid, N.A., Bergstrom, R.F., Ziege, E.A., Parli, C.J., and Lemberger, L. Single-Dose and Steady-State Pharmacokinetics of Tomoxetine in Normal Subjects. J. Clin. Pharmacol. 25:296-301, 1985. 15. Lemberger, L., Bergstrom, R.F., Wolen, R.L., Farid, N.A., Enas, G.G., and Aronoff, G.R. Fluoxetine: Clinical Pharmacology and Physiologic Disposition. J. Clin. Psych. 46(3):14-19, 1985. 16. Knadler, M.P., Bergstrom, R.F., Callaghan, J.T., and Rubin, A. Nizatidine, An H2- Blocker: Its Metabolism and Disposition in Man. Drug Metab. Dispos. 14(2):175-182, 1986. 17. Galloway, J.A., Root, M.A., Bergstrom, R., Spradlin, C.T., Howey, D.C., Fineberg, S.E., and Jackson, R.L. Clinical Pharmacologic Studies with Human Insulin (recombinant DNA). Diabetes Care 2(S5):13-22, 1982. 18. Callaghan, J.T., Bergstrom, R.F., Rubin, A., Chernish, S., Crabtree, R., Knadler, M.P., Obermeyer, B., Offen, W.W., Schneck, D.W., Aronoff, G., Lasseter, K.C. A Pharmacokinetic Profile of Nizatidine in Man. Scan. J. Gastero. 22(S136):9-17, 1987. 19. Callaghan, J.T., Rubin, A., Knadler, M.P., and Bergstrom, R.F. Nizatidine, an H2- Receptor Antagonist: Disposition and Safety in the Elderly. J. Clin. Pharmacol. 27:618-624, 1987. 20. Knadler, M.P., Bergstrom, R.F., Callaghan, J.T., Obermeyer, B.D., and Rubin, A. Absorption Studies of the H2-Blocker Nizatidine. Clin. Pharmacol. Ther. 42(5):514-520, 1987. 21. Lemberger, L., Rowe, H., Bergstrom, R., Bosomworth, J., and Tenbarge, J. The Effect of Fluoxetine on the Pharmacokinetics and Psychomotor Responses of Diazepam. Clin. Pharmacol. Ther. 43(4):412-419, 1988. 22. Lemberger, L., Farid, N.A., Bergstrom, R.F. and Wolen, R.L. Fluoxetine, Pharmacology and Physiologic Disposition. Int. J. Obesity 11(S3):157-161, 1987. 23. Aronoff, G.R., Bergstrom, R.F., Bopp, R.J., Sloan, R.S., and Callaghan, J.T. Nizatidine Disposition in Subjects with Normal and Impaired Renal Function. Clin. Pharmacol. Ther. 43(6):688-695, 1988. 24. Bergstrom, R.F., Lemberger, L., Farid, N.A., and Wolen, R.L. Clinical Pharmacology and Pharmacokinetics of Fluoxetine: A Review. Br. J. Psych. 153(S3):47-50, 1988. 25. Schenker, S., Bergstrom, R.F., Wolen, R.L., and Lemberger, L. Fluoxetine Disposition and Elimination in Cirrhosis. Clin. Pharmacol. Ther. 44(3):353-359, 1988. 26. Lalka, S.G., Malone, J.M., Fischer, D.F., Jr., Bernhard, V.M., Sullivan, D., Stoeckelmann, D., and Bergstrom, R.F. Efficacy of Prophylactic Antibiotics in Vascular Surgery: An Atrerial Wall Microbioloogic and Pharmacokinetic Perspective. J. Vas. Surg. 10(5):501-510, 1989. 27. Bergstrom, R.F., and Lemberger L. First Time Studies in Man: An Industrial Perspective. in Controversy V: Phase I, First Time in Man Studies. Ed. Colburn, W.A. J. Clin. Pharmacol. 30(3):210-222, 1990. 28. Schneck, D.W., Callaghan, J.T., Bergstrom, R.F., Obermeyer, B.D., and Offen, W.W. Relationship Between Steady-State Plasma Nizatidine Concentrations and Inhibition of Basel and Stimulated Gastric Acid Secretion. Clin. Pharmacol. Ther. 47(4):499-503, 1990. 29. Obermeyer, B.D., Bergstrom, R.F., Callaghan J.T., Knadler M.P., Golichowski A., and Rubin A. Secretion of Nizatidine into Human Breast Milk after Single and Multiple Doses. Clin. Pharmacol. Ther. 47(6):724-730, 1990. 30. Kreis, W., Budman, D.R., Freeman, J., Bergstrom, R.F., and Nelson, R.L. Clinical Pharmacokinetics of Intravenously Injected Tritiated Vinzolidine. Cancer Chemother. Pharmacol. 26:419-422, 1990. 31. Bergstrom, R.F., Peyton, A.L., and Lemberger, L. Quantification and Mechanism of the Fluoxetine and Tricyclic Antidepressant Interaction. Clin. Pharmacol. Ther. 51(3):239-248, 1992. 32. Bergstrom, R.F., Beasley, C.M., Levy, N.B., Blumenfield M., and Lemberger, L. The Effect of Renal and Hepatic Disease on the pharmacokinetics, Renal Tolerance, and Risk-Benefit Profile of Fluoxetine. Internat. Clin. Psychopharmacol. 8(4):261-266, 1993. 33. Levy, N.B., Blumenfield, M., Beasley, C.M., Dubey, A.K., Solomon, R.J., Todd, R., Goodman, A. and Bergstrom R.F. Fluoxetine in Depressed-Patients with Renal-Failure and in Depressed-Patients with Normal Kidney-Function. Gen. Hosp. Psy. 18(1):8-13, 1996. 34. Kurtz, D.L., Bergstrom, R.F., Goldberg, M.J. and Cerimele, B.J. The Effect of Sertraline on the Pharmacokinetics of Desipramine and Imipramine. Clin. Pharmacol. Ther. 62(2):145-56, 1997. 35. Bergstrom, R.F., Goldberg, M.J., Cerimele, B.J., and Hatcher, B.L. Assessment of the Potential for a Pharmacokinetic Interaction Between Fluoxetine and Terfenadine. Clin. Pharmacol. Ther. 62:643-51 1997. 36. Blumenfield M., Levy N.B., Spinowitz B, Charytan C., Beasley C.M. Jr., Dubey A.K. Solomon R.J., Todd R., Goodman A., Bergstrom R.F. Fluoxetine in Depressed Patients on Dialysis. Internat. J. Psyc. in Med. 27(1):71-80 1997. 37. Lucas R.A., Gilfillan D.J., and Bergstrom R.F. A Pharmacokinetic Interaction Between Carbamazepine and Olanzapine: Observations on Possible Mechanism. European J Clin Pharmacol. 54:639-43 1998. 38. Macias, W.L., Bergstrom, R.F., Cerimele, B.J., Kassahun K., Tatum, D.E., and Callaghan J.T. Lack of a Pharmacokinetic Interaction Between Olanzapine and Theophylline. Pharmacotherapy 18(6):1237-1248 1998. 39. Callaghan J.T., Bergstrom R.F., Ptak L.R., and Beasley C.M. Jr. Olanzapine: Pharmacokinetics, Pharmacodynamics, and Clinical Trial Profile. Clinical Pharmacokinetics 37(3):177-193 1999. 40. Grothe D.R., Calis K.A., Jacobsen L., Kumra S., DeVane C.L., Rapoport J.L., Bergstrom R.F., and Kurtz D.L. Olanzapine Pharmacokinetics in Pediatric and Adolescent Inpatients with Childhood Onset Schizophrenia. J Clin Psychopharmacol. 20(2):220-5, 2000. 41. Sathirakul K., Chan C., Teng L., Bergstrom R.F., Yeo K.P., Wise S.D. Olanzapine Pharmacokinetics Are Similar in Chinese and Caucasian Subjects. Br. J. Clin. Phamacol. 56:184-187, 2003. 42. Lobo ED. Loghin C. Knadler MP. Quinlan T. Zhang L. Chappell J. Lucas R. Bergstrom RF. Pharmacokinetics of duloxetine in breast milk and plasma of healthy postpartum women. Clinical Pharmacokinetics. 47(2):103-9, 2008. 43. Lobo ED. Bergstrom RF. Reddy S. Quinlan T. Chappell J. Hong Q. Ring B. Knadler MP. In vitro and in vivo evaluations of cytochrome P450 1A2 interactions with duloxetine. Clinical Pharmacokinetics. 47(3):191-202, 2008. 44. Tohen M. Bowden CL. Smulevich AB. Bergstrom R. Quinlan T. Osuntokun O. Wang WV. Oliff HS. Martenyi F. Kryzhanovskaya LA. Greil W. Olanzapine plus carbamazepine v. carbamazepine alone in treating manic episodes. British Journal of Psychiatry. 192(2):135-43, 2008 Feb. 45. Citrome L. Stauffer VL. Chen L. Kinon BJ. Kurtz DL. Jacobson JG. Bergstrom RF. Olanzapine plasma concentrations after treatment with 10, 20, and 40 mg/d in patients with schizophrenia: an analysis of correlations with efficacy, weight gain, and prolactin concentration. Journal of Clinical Psychopharmacology. 29(3):278-83, Jun 2009. 46. Kane J.M., Detke H.C., Naber D., Sethuraman G., Lin D.Y., Bergstrom R.F., and McDonnellD. Olanzapine Long-Acting Injection: A 24-Week, Randomized, Double-Blind Trial of Maintenance Treatment in Patients With Schizophrenia. Am J Psychiatry 167: 181 - 189 Feb 2010. 47. Lobo E.D., Robertson-Plouch C., Quinlan T., Hong Q., Bergstrom R.F. Oral Olanzapine Disposition in Adolescents with Schizophrenia or Bipolar I Disorder: A Population Pharmacokinetic Model. Paediatr Drugs 2010 Jun;12(3):201-11. 48. McDonnell D.P., Detke H.C., Bergstrom R.F., Kothare P., Johnson J., Stickelmeyer M., Sanchez-Felix M.V., Sorsaburu S., and Mitchell M.I. Post-injection Delirium/Sedation Syndrome in Patients with Schizophrenia Treated with Olanzapine Long-Acting Injection: II. Investigations of Mechanism. BMC Psychiatry 2010 Jun 10;10:45. 49. Knadler MP, Lobo E, Chappell J, Bergstrom R. Duloxetine: clinical pharmacokinetics and drug interactions. Clin Pharmacokinet. 2011 May 1;50(5):281-94. 50. Mitchell M, Kothare P, Bergstrom R, Zhao F, Jen KY, Walker D, Johnson J, McDonnell D. Single and Multiple-Dose Pharmacokinetics, Safety and Tolerability Profiles of Olanzapine Long-Acting Injection (LAI) in Patients with Schizophrenia. Clin Ther. (in press) 2011. BIBLIOGRAPHY- BOOKS AND CHAPTERS
Quay, J.F., and Bergstrom, R.F. Pharmacology and Pharmacokinetics of Penicillins. In Beta-Lactam Antibiotics For Clinical Use. Ed. Queener, S.F., Webber, A.J., and Queener, S.W. Marcel Dekker Inc., New York, pp 163-224, 1986. Kroboth, P.D., Schwinghammer, T.L., and Bergstrom, R.F. H Antagonists: Choosing a Model. In Pharmacokinetics and Pharmacodynamics: Current Problems, Potential Solutions. Ed. Kroboth, P.D., Smith, R.B., and Juhl, R.P. Harvey Whitney Books Company, Cincinnati, Ohio, pp 10-28, 1988. Library of Congress: 88-050443 Bergstrom RF, Callaghan JT, Cerimele BJ, Kurtz, DL, and Hatcher BL. Population Pharmacokinetics and Plasma Concentrations of Olanzapine. In Olanzapine (Zyprexa®): A Novel Antipsychotic edited by Tran PV, Bymaster FP, Tye N, Herrera JM, Brier A, and Tollefson, GD. Lippincott, Williams and Wilkins, Philladelphia 2000, pp 232-252. Callaghan JT, and Bergstrom RF. Olanzapine: Drug Interactions. In Olanzapine (Zyprexa®): A Novel Antipsychotic edited by Tran PV, Bymaster FP, Tye N, Herrera JM, Brier A, and Tollefson, GD. Lippincott, Williams and Wilkins, Philladelphia 2000, pp 253-264. REFERENCES
Dr. Ho-Leung Fung, University at Buffalo, State University of New York, Buffalo, NY 14260 Professor of Pharmaceutical Sciences email: hlfung@acsu.buffalo.edu Phone: 716-645-4843 Dr. David Smith, University of Michigan, Ann Arbor, MI 48109 Professor and Chair of Pharmaceutical Sciences email: smithb@umich.edu Phone: 734-647-1431 Dr. Lisa Shipley, Merck and Co., Inc., West Point, PA 19486 Vice President & Global Head Drug Metabolism and Pharmacokinetics email: lisa_shipley2@merck.com Phone: 215-652-6128 Dr. Sandra R. B. Allerheiligen, Merck and Co., Inc. West Point, PA 19486 Vice President of Modeling and Clinical Trial Simulation email: sandra.allerheiligen@merck.com Phone: 267-305-3086 Dr. Gregg Lundeen, Eli Lilly and Co., Indianapolis, IN 46285 Vice President Toxicology, Drug Disposition, and PK/PD email: grl@lilly.com Phone: 317-277-1608 REVISED: OCTOBER, 2011

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